COPD

DRESSLERVILLE, NEV. – Smoke began billowing into the skies of northwestern Nevada in September, clouding the mountains, dimming the sun – and quashing residents’ hopes that they would be spared from wildfires and the awful air quality the blazes produce.

The lung-irritating particles were blowing in from burning forests in California and settling in Douglas County, Nevada, home to nearly 50,000 people, prompting warnings that air quality had reached hazardous levels.

Those levels meant the air was very unhealthy, bad enough to raise alarms about people’s immediate health care needs and questions about whether worsening pollution could result in long-term health issues. People could increasingly face such risks as climate change makes wildfires, drought, dust storms, and floods more frequent across the United States and the world.

Some people simply feel powerless.

“There’s not much we could do about it,” said Serrell Smokey, chairman of the Washoe Tribe of Nevada and California. The tribe’s land straddles the border between California and Nevada near Lake Tahoe and extends into Douglas County, about 60 miles south of Reno.

Tribe members and other area residents are among millions of people nationwide who this year will experience poor air quality because of wildfires. In September, as smoke settled over Nevada, fire-related air quality alerts were dispatched in six other states: California, Idaho, Montana, Oregon, Washington, and Wyoming.

Yet, by one measure, people who live in Douglas County are better off than those in some other hard-hit areas. Douglas County residents must drive 30 minutes, on average, for medical care from lung specialists called pulmonologists. In other parts of the West and Upper Midwest, however, patients must drive an hour or more, according to data analyzed by GoodRx, a website that tracks prescription drug prices and conducts research.

Specifically, the research found that about 5.5 million Americans live in the 488 counties where drive times to pulmonologists are an hour or more. Much of Nevada and large parts of Montana fall into those gaps between specialists – places that have recently grappled with wildfires that fill the air with smoke and ash, which can cause lung problems or exacerbate existing ones.

Allergies, asthma, and similar issues are often handled by primary care physicians, but patients are sent to pulmonologists when problems escalate – think severe asthma; chronic obstructive pulmonary disease, or COPD; or emphysema.

Data from the Association of American Medical Colleges shows the number of pulmonary disease specialists in the United States dropped nearly 11% from 2014 to 2019. The group, which is based in Washington, D.C., and represents the academic medicine community, noted that the decline might not be as high as it appears because some physicians are opting to practice pulmonary critical care rather than just pulmonology. Many of those types of pulmonologists work in hospital intensive care units.

About 15,000 pulmonologists are practicing in the United States, according to the GoodRx report. Yet vast swaths of the country have few or none.

“New Mexico has one pulmonologist for the entire southeastern part of state, not counting Las Cruces, which is closer to El Paso,” said Victor Test, MD, a pulmonologist at Texas Tech Physicians.

Dr. Test, one of 13 pulmonologists in the Lubbock, Tex., region, said that his patients from within Texas sometimes drive 4 hours for an appointment and that other people travel from “New Mexico, Oklahoma, even far western Kansas.”

Increases in wildfires and their intensity will likely expand the need for pulmonologists.

“Climate change is going to affect lung disease,” said Nicholas Kenyon, MD, a professor of pulmonary, critical care, and sleep medicine at the University of California, Davis, where he and several other researchers are tracking the effects of wildfires. At his Sacramento practice, Dr. Kenyon said, he sees patients from far northern parts of California, including Eureka, a 5-hour drive from the state capital.

The short-term effects of breathing smoke are pretty well known. People show up in emergency rooms with asthma attacks, exacerbation of COPD, bronchitis, and even pneumonia, Dr. Kenyon said. Some have chest pain or other cardiac concerns.

“But we have very little understanding of what happens over the longer term,” he said. “If people get 2 or 3 weeks of wildfire exposure for 2 or 3 years, does that lead to worsening of asthma or COPD? We just don’t know.”

Fires release multiple pollutants, including carbon dioxide, carbon monoxide, and chemicals like benzene. All fires send particles into the air. Health researchers and air quality experts are most concerned about tiny pieces referred to as particulate matter 2.5. Far smaller than a human hair, the particles can lodge deep in the lungs and have been linked to heart and lung conditions.

Increases in those tiny particles are associated with a greater risk of death from all causes, excluding accidents, homicides, and other nonaccidental causes, for up to 4 days after a population is exposed, according to a 2020 New England Journal of Medicine overview.

The concentration of fine particulate matter is one of five gauges used to calculate the Air Quality Index, a numerical and color-coded index used to let the public know about local air pollution levels. Green denotes good air quality and is given if the total index is 50 or less. When the measurement exceeds 100, the air quality gets an orange label and may be bad for certain groups. Levels over 200 get a red label and are considered unhealthy for everyone.

Government agencies track those levels, as do people who use apps or websites to determine whether it’s safe to go outside.

When the AQI rises above 150, Farah Madhani-Lovely, MD, a pulmonologist, said, Renown Regional Medical Center in Reno shuts its outpatient pulmonary rehabilitation clinic because it doesn’t want to encourage patients to drive in. Some patients from Douglas County opt for care near home, about an hour away. “We don’t want these patients exposed outside because just 1 minute of exposure to the smoke can trigger an exacerbation of their chronic disease,” Dr. Madhani-Lovely said.

Mr. Smokey said connecting with pulmonologists can be difficult for Washoe Tribe members, particularly those who live on the California side of the reservation. “We cannot find providers for them,” he said. “We end up referring them out and sending them hundreds of miles out of their way just to get care that we should be able to provide here.”

Recruiting specialists to rural areas or smaller cities has long been difficult. For one thing, a specialist might be the only one for miles around, “so there’s a tremendous burden in terms of coverage and days off,” Dr. Test said.

Another concern is that physicians tend to train in larger cities and often want to practice in similar places. Even recruiting pulmonary physicians to Lubbock, a city of 260,000 in West Texas, is a challenge, Dr. Test said.

“I love Lubbock,” he said. “But I tell people who have never been here, I say, ‘It’s really flat.’ They don’t understand flat until they get here.”

In Nevada, on days when the air quality is bad, Washoe tribal members try to protect themselves with makeshift air purifiers created from fans, duct tape, and air filters, Mr. Smokey said.

Longer term, Mr. Smokey and other tribal leaders are pushing the Indian Health Service to establish a specialty care hospital in northern Nevada. The closest specialty care hospital for Washoe tribal members is more than 700 miles away, in Phoenix.

It’s difficult because “there’s a need we should be taking care of,” Mr. Smokey said. “But we have to fight for it. And sometimes that fight takes years, years, and years to accomplish.”
 

A version of this article first appeared on Medscape.com.

DRESSLERVILLE, NEV. – Smoke began billowing into the skies of northwestern Nevada in September, clouding the mountains, dimming the sun – and quashing residents’ hopes that they would be spared from wildfires and the awful air quality the blazes produce.

The lung-irritating particles were blowing in from burning forests in California and settling in Douglas County, Nevada, home to nearly 50,000 people, prompting warnings that air quality had reached hazardous levels.

Those levels meant the air was very unhealthy, bad enough to raise alarms about people’s immediate health care needs and questions about whether worsening pollution could result in long-term health issues. People could increasingly face such risks as climate change makes wildfires, drought, dust storms, and floods more frequent across the United States and the world.

Some people simply feel powerless.

“There’s not much we could do about it,” said Serrell Smokey, chairman of the Washoe Tribe of Nevada and California. The tribe’s land straddles the border between California and Nevada near Lake Tahoe and extends into Douglas County, about 60 miles south of Reno.

Tribe members and other area residents are among millions of people nationwide who this year will experience poor air quality because of wildfires. In September, as smoke settled over Nevada, fire-related air quality alerts were dispatched in six other states: California, Idaho, Montana, Oregon, Washington, and Wyoming.

Yet, by one measure, people who live in Douglas County are better off than those in some other hard-hit areas. Douglas County residents must drive 30 minutes, on average, for medical care from lung specialists called pulmonologists. In other parts of the West and Upper Midwest, however, patients must drive an hour or more, according to data analyzed by GoodRx, a website that tracks prescription drug prices and conducts research.

Specifically, the research found that about 5.5 million Americans live in the 488 counties where drive times to pulmonologists are an hour or more. Much of Nevada and large parts of Montana fall into those gaps between specialists – places that have recently grappled with wildfires that fill the air with smoke and ash, which can cause lung problems or exacerbate existing ones.

Allergies, asthma, and similar issues are often handled by primary care physicians, but patients are sent to pulmonologists when problems escalate – think severe asthma; chronic obstructive pulmonary disease, or COPD; or emphysema.

Data from the Association of American Medical Colleges shows the number of pulmonary disease specialists in the United States dropped nearly 11% from 2014 to 2019. The group, which is based in Washington, D.C., and represents the academic medicine community, noted that the decline might not be as high as it appears because some physicians are opting to practice pulmonary critical care rather than just pulmonology. Many of those types of pulmonologists work in hospital intensive care units.

About 15,000 pulmonologists are practicing in the United States, according to the GoodRx report. Yet vast swaths of the country have few or none.

“New Mexico has one pulmonologist for the entire southeastern part of state, not counting Las Cruces, which is closer to El Paso,” said Victor Test, MD, a pulmonologist at Texas Tech Physicians.

Dr. Test, one of 13 pulmonologists in the Lubbock, Tex., region, said that his patients from within Texas sometimes drive 4 hours for an appointment and that other people travel from “New Mexico, Oklahoma, even far western Kansas.”

Increases in wildfires and their intensity will likely expand the need for pulmonologists.

“Climate change is going to affect lung disease,” said Nicholas Kenyon, MD, a professor of pulmonary, critical care, and sleep medicine at the University of California, Davis, where he and several other researchers are tracking the effects of wildfires. At his Sacramento practice, Dr. Kenyon said, he sees patients from far northern parts of California, including Eureka, a 5-hour drive from the state capital.

The short-term effects of breathing smoke are pretty well known. People show up in emergency rooms with asthma attacks, exacerbation of COPD, bronchitis, and even pneumonia, Dr. Kenyon said. Some have chest pain or other cardiac concerns.

“But we have very little understanding of what happens over the longer term,” he said. “If people get 2 or 3 weeks of wildfire exposure for 2 or 3 years, does that lead to worsening of asthma or COPD? We just don’t know.”

Fires release multiple pollutants, including carbon dioxide, carbon monoxide, and chemicals like benzene. All fires send particles into the air. Health researchers and air quality experts are most concerned about tiny pieces referred to as particulate matter 2.5. Far smaller than a human hair, the particles can lodge deep in the lungs and have been linked to heart and lung conditions.

Increases in those tiny particles are associated with a greater risk of death from all causes, excluding accidents, homicides, and other nonaccidental causes, for up to 4 days after a population is exposed, according to a 2020 New England Journal of Medicine overview.

The concentration of fine particulate matter is one of five gauges used to calculate the Air Quality Index, a numerical and color-coded index used to let the public know about local air pollution levels. Green denotes good air quality and is given if the total index is 50 or less. When the measurement exceeds 100, the air quality gets an orange label and may be bad for certain groups. Levels over 200 get a red label and are considered unhealthy for everyone.

Government agencies track those levels, as do people who use apps or websites to determine whether it’s safe to go outside.

When the AQI rises above 150, Farah Madhani-Lovely, MD, a pulmonologist, said, Renown Regional Medical Center in Reno shuts its outpatient pulmonary rehabilitation clinic because it doesn’t want to encourage patients to drive in. Some patients from Douglas County opt for care near home, about an hour away. “We don’t want these patients exposed outside because just 1 minute of exposure to the smoke can trigger an exacerbation of their chronic disease,” Dr. Madhani-Lovely said.

Mr. Smokey said connecting with pulmonologists can be difficult for Washoe Tribe members, particularly those who live on the California side of the reservation. “We cannot find providers for them,” he said. “We end up referring them out and sending them hundreds of miles out of their way just to get care that we should be able to provide here.”

Recruiting specialists to rural areas or smaller cities has long been difficult. For one thing, a specialist might be the only one for miles around, “so there’s a tremendous burden in terms of coverage and days off,” Dr. Test said.

Another concern is that physicians tend to train in larger cities and often want to practice in similar places. Even recruiting pulmonary physicians to Lubbock, a city of 260,000 in West Texas, is a challenge, Dr. Test said.

“I love Lubbock,” he said. “But I tell people who have never been here, I say, ‘It’s really flat.’ They don’t understand flat until they get here.”

In Nevada, on days when the air quality is bad, Washoe tribal members try to protect themselves with makeshift air purifiers created from fans, duct tape, and air filters, Mr. Smokey said.

Longer term, Mr. Smokey and other tribal leaders are pushing the Indian Health Service to establish a specialty care hospital in northern Nevada. The closest specialty care hospital for Washoe tribal members is more than 700 miles away, in Phoenix.

It’s difficult because “there’s a need we should be taking care of,” Mr. Smokey said. “But we have to fight for it. And sometimes that fight takes years, years, and years to accomplish.”
 

A version of this article first appeared on Medscape.com.

DRESSLERVILLE, NEV. – Smoke began billowing into the skies of northwestern Nevada in September, clouding the mountains, dimming the sun – and quashing residents’ hopes that they would be spared from wildfires and the awful air quality the blazes produce.

The lung-irritating particles were blowing in from burning forests in California and settling in Douglas County, Nevada, home to nearly 50,000 people, prompting warnings that air quality had reached hazardous levels.

Those levels meant the air was very unhealthy, bad enough to raise alarms about people’s immediate health care needs and questions about whether worsening pollution could result in long-term health issues. People could increasingly face such risks as climate change makes wildfires, drought, dust storms, and floods more frequent across the United States and the world.

Some people simply feel powerless.

“There’s not much we could do about it,” said Serrell Smokey, chairman of the Washoe Tribe of Nevada and California. The tribe’s land straddles the border between California and Nevada near Lake Tahoe and extends into Douglas County, about 60 miles south of Reno.

Tribe members and other area residents are among millions of people nationwide who this year will experience poor air quality because of wildfires. In September, as smoke settled over Nevada, fire-related air quality alerts were dispatched in six other states: California, Idaho, Montana, Oregon, Washington, and Wyoming.

Yet, by one measure, people who live in Douglas County are better off than those in some other hard-hit areas. Douglas County residents must drive 30 minutes, on average, for medical care from lung specialists called pulmonologists. In other parts of the West and Upper Midwest, however, patients must drive an hour or more, according to data analyzed by GoodRx, a website that tracks prescription drug prices and conducts research.

Specifically, the research found that about 5.5 million Americans live in the 488 counties where drive times to pulmonologists are an hour or more. Much of Nevada and large parts of Montana fall into those gaps between specialists – places that have recently grappled with wildfires that fill the air with smoke and ash, which can cause lung problems or exacerbate existing ones.

Allergies, asthma, and similar issues are often handled by primary care physicians, but patients are sent to pulmonologists when problems escalate – think severe asthma; chronic obstructive pulmonary disease, or COPD; or emphysema.

Data from the Association of American Medical Colleges shows the number of pulmonary disease specialists in the United States dropped nearly 11% from 2014 to 2019. The group, which is based in Washington, D.C., and represents the academic medicine community, noted that the decline might not be as high as it appears because some physicians are opting to practice pulmonary critical care rather than just pulmonology. Many of those types of pulmonologists work in hospital intensive care units.

About 15,000 pulmonologists are practicing in the United States, according to the GoodRx report. Yet vast swaths of the country have few or none.

“New Mexico has one pulmonologist for the entire southeastern part of state, not counting Las Cruces, which is closer to El Paso,” said Victor Test, MD, a pulmonologist at Texas Tech Physicians.

Dr. Test, one of 13 pulmonologists in the Lubbock, Tex., region, said that his patients from within Texas sometimes drive 4 hours for an appointment and that other people travel from “New Mexico, Oklahoma, even far western Kansas.”

Increases in wildfires and their intensity will likely expand the need for pulmonologists.

“Climate change is going to affect lung disease,” said Nicholas Kenyon, MD, a professor of pulmonary, critical care, and sleep medicine at the University of California, Davis, where he and several other researchers are tracking the effects of wildfires. At his Sacramento practice, Dr. Kenyon said, he sees patients from far northern parts of California, including Eureka, a 5-hour drive from the state capital.

The short-term effects of breathing smoke are pretty well known. People show up in emergency rooms with asthma attacks, exacerbation of COPD, bronchitis, and even pneumonia, Dr. Kenyon said. Some have chest pain or other cardiac concerns.

“But we have very little understanding of what happens over the longer term,” he said. “If people get 2 or 3 weeks of wildfire exposure for 2 or 3 years, does that lead to worsening of asthma or COPD? We just don’t know.”

Fires release multiple pollutants, including carbon dioxide, carbon monoxide, and chemicals like benzene. All fires send particles into the air. Health researchers and air quality experts are most concerned about tiny pieces referred to as particulate matter 2.5. Far smaller than a human hair, the particles can lodge deep in the lungs and have been linked to heart and lung conditions.

Increases in those tiny particles are associated with a greater risk of death from all causes, excluding accidents, homicides, and other nonaccidental causes, for up to 4 days after a population is exposed, according to a 2020 New England Journal of Medicine overview.

The concentration of fine particulate matter is one of five gauges used to calculate the Air Quality Index, a numerical and color-coded index used to let the public know about local air pollution levels. Green denotes good air quality and is given if the total index is 50 or less. When the measurement exceeds 100, the air quality gets an orange label and may be bad for certain groups. Levels over 200 get a red label and are considered unhealthy for everyone.

Government agencies track those levels, as do people who use apps or websites to determine whether it’s safe to go outside.

When the AQI rises above 150, Farah Madhani-Lovely, MD, a pulmonologist, said, Renown Regional Medical Center in Reno shuts its outpatient pulmonary rehabilitation clinic because it doesn’t want to encourage patients to drive in. Some patients from Douglas County opt for care near home, about an hour away. “We don’t want these patients exposed outside because just 1 minute of exposure to the smoke can trigger an exacerbation of their chronic disease,” Dr. Madhani-Lovely said.

Mr. Smokey said connecting with pulmonologists can be difficult for Washoe Tribe members, particularly those who live on the California side of the reservation. “We cannot find providers for them,” he said. “We end up referring them out and sending them hundreds of miles out of their way just to get care that we should be able to provide here.”

Recruiting specialists to rural areas or smaller cities has long been difficult. For one thing, a specialist might be the only one for miles around, “so there’s a tremendous burden in terms of coverage and days off,” Dr. Test said.

Another concern is that physicians tend to train in larger cities and often want to practice in similar places. Even recruiting pulmonary physicians to Lubbock, a city of 260,000 in West Texas, is a challenge, Dr. Test said.

“I love Lubbock,” he said. “But I tell people who have never been here, I say, ‘It’s really flat.’ They don’t understand flat until they get here.”

In Nevada, on days when the air quality is bad, Washoe tribal members try to protect themselves with makeshift air purifiers created from fans, duct tape, and air filters, Mr. Smokey said.

Longer term, Mr. Smokey and other tribal leaders are pushing the Indian Health Service to establish a specialty care hospital in northern Nevada. The closest specialty care hospital for Washoe tribal members is more than 700 miles away, in Phoenix.

It’s difficult because “there’s a need we should be taking care of,” Mr. Smokey said. “But we have to fight for it. And sometimes that fight takes years, years, and years to accomplish.”
 

A version of this article first appeared on Medscape.com.

BARCELONA – For patients with emphysema who are suitable candidates for lung volume reduction surgery, there were no differences at 1 year in either lung function, dyspnea, or exercise capacity between patients who were assigned to undergo standard lung volume reduction surgery (LVRS) or bronchoscopic lung volume reduction with endobrachial valves (BLVR-EBV) in a randomized trial.

Among patients with emphysema amenable to surgery, there were similar improvements between the treatment groups at 12-month follow-up as assessed by the iBODE score, a composite disease severity measure incorporating body mass index, airflow obstruction, dyspnea, and exercise capacity (incremental shuttle walk test), reported Sara Buttery, BSc, a research physiotherapist and PhD candidate at the National Heart and Lung Institute at Imperial College London.

“Until now there had been no direct comparison of the two to inform decision-making when a person seems to be suitable for either. Bronchoscopic lung volume reduction is a less invasive option and is thought to be ‘less risky’ but, until now, there has not been substantial research to support this,” she said at the annual congress of the European Respiratory Society.

Ms. Buttery and colleagues conducted a randomized, controlled, single-blinded superiority trial to see whether LVRS could be superior to BLVR with valves. They enrolled 88 patients (52% male) with a mean age of 64, and randomly assigned them to receive either LVRS (41 patients) or the less-invasive BLVR (47 patients).

As noted before, there were no significant differences in outcomes at 1 year, with similar degrees of improvement between the surgical techniques for both the composite iBODE score (–1.10 for LVRS vs. –0.82 for BLVR, nonsignificant), and for the individual components of the score.

In addition, the treatments were associated with similar reductions in gas trapping, with residual volume percentage predicted –36.1 with LVRS versus –30.5 with BLVR (nonsignificant).

One patient in each group died during the 12 months of follow-up. The death of the patient in the BLVR group was deemed to be treatment related; the death of the patient in the LVRS group was related to a noninfective exacerbation of chronic obstructive pulmonary disease.

Invited discussant Isabelle Opitz, MD, from University Hospital Zürich told Ms. Buttery: “I have to congratulate you for this very first randomized controlled trial comparing both procedures in a superiority design.”

She pointed out, however, that the number of patients lost to follow-up and crossover of some patients randomized to bronchoscopy raised questions about the powering of the study.

“We did a sensitivity analysis to have a look to see if there was any difference between the patients who did return and the ones who didn’t, and there was no difference at baseline between those patients.” Ms. Buttery said.

She noted that follow-up visits were hampered by the COVID-19 pandemic and the inability of many patients to come into the clinic.

Dr. Opitz also asked about COPD Assessment Test (CAT) scores that were included in the trial design but not reported in the presentation. Ms. Buttery said that the CAT results favored the LVRS group, and that the results would be included in a future economic analysis.

“The results from this first randomized controlled trial suggest that BLVR may be a good therapeutic option for those patients for whom either procedure is suitable,” said Alexander Mathioudakis, MD, PhD, from the University of Manchester (England), who was not involved with this study but commented on it in a press statement. “Lung volume reduction surgery is an invasive operation as it requires a small incision to be made in the chest, which is stitched up after the procedure. As such, it has risks associated with surgery and it takes longer to recover from than bronchoscopic lung volume reduction. On the other hand, endobronchial valves placement is also associated with side effects, such as pneumonia, or valve displacement. Therefore, both the safety and effectiveness of the two procedures need to be investigated further, in larger groups of patients, but the results from this trial are very encouraging.”

The study is supported by the U.K. National Institute of Health Research. Ms. Buttery, Dr. Opitz, and Dr. Mathioudakis reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

BARCELONA – For patients with emphysema who are suitable candidates for lung volume reduction surgery, there were no differences at 1 year in either lung function, dyspnea, or exercise capacity between patients who were assigned to undergo standard lung volume reduction surgery (LVRS) or bronchoscopic lung volume reduction with endobrachial valves (BLVR-EBV) in a randomized trial.

Among patients with emphysema amenable to surgery, there were similar improvements between the treatment groups at 12-month follow-up as assessed by the iBODE score, a composite disease severity measure incorporating body mass index, airflow obstruction, dyspnea, and exercise capacity (incremental shuttle walk test), reported Sara Buttery, BSc, a research physiotherapist and PhD candidate at the National Heart and Lung Institute at Imperial College London.

“Until now there had been no direct comparison of the two to inform decision-making when a person seems to be suitable for either. Bronchoscopic lung volume reduction is a less invasive option and is thought to be ‘less risky’ but, until now, there has not been substantial research to support this,” she said at the annual congress of the European Respiratory Society.

Ms. Buttery and colleagues conducted a randomized, controlled, single-blinded superiority trial to see whether LVRS could be superior to BLVR with valves. They enrolled 88 patients (52% male) with a mean age of 64, and randomly assigned them to receive either LVRS (41 patients) or the less-invasive BLVR (47 patients).

As noted before, there were no significant differences in outcomes at 1 year, with similar degrees of improvement between the surgical techniques for both the composite iBODE score (–1.10 for LVRS vs. –0.82 for BLVR, nonsignificant), and for the individual components of the score.

In addition, the treatments were associated with similar reductions in gas trapping, with residual volume percentage predicted –36.1 with LVRS versus –30.5 with BLVR (nonsignificant).

One patient in each group died during the 12 months of follow-up. The death of the patient in the BLVR group was deemed to be treatment related; the death of the patient in the LVRS group was related to a noninfective exacerbation of chronic obstructive pulmonary disease.

Invited discussant Isabelle Opitz, MD, from University Hospital Zürich told Ms. Buttery: “I have to congratulate you for this very first randomized controlled trial comparing both procedures in a superiority design.”

She pointed out, however, that the number of patients lost to follow-up and crossover of some patients randomized to bronchoscopy raised questions about the powering of the study.

“We did a sensitivity analysis to have a look to see if there was any difference between the patients who did return and the ones who didn’t, and there was no difference at baseline between those patients.” Ms. Buttery said.

She noted that follow-up visits were hampered by the COVID-19 pandemic and the inability of many patients to come into the clinic.

Dr. Opitz also asked about COPD Assessment Test (CAT) scores that were included in the trial design but not reported in the presentation. Ms. Buttery said that the CAT results favored the LVRS group, and that the results would be included in a future economic analysis.

“The results from this first randomized controlled trial suggest that BLVR may be a good therapeutic option for those patients for whom either procedure is suitable,” said Alexander Mathioudakis, MD, PhD, from the University of Manchester (England), who was not involved with this study but commented on it in a press statement. “Lung volume reduction surgery is an invasive operation as it requires a small incision to be made in the chest, which is stitched up after the procedure. As such, it has risks associated with surgery and it takes longer to recover from than bronchoscopic lung volume reduction. On the other hand, endobronchial valves placement is also associated with side effects, such as pneumonia, or valve displacement. Therefore, both the safety and effectiveness of the two procedures need to be investigated further, in larger groups of patients, but the results from this trial are very encouraging.”

The study is supported by the U.K. National Institute of Health Research. Ms. Buttery, Dr. Opitz, and Dr. Mathioudakis reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

BARCELONA – For patients with emphysema who are suitable candidates for lung volume reduction surgery, there were no differences at 1 year in either lung function, dyspnea, or exercise capacity between patients who were assigned to undergo standard lung volume reduction surgery (LVRS) or bronchoscopic lung volume reduction with endobrachial valves (BLVR-EBV) in a randomized trial.

Among patients with emphysema amenable to surgery, there were similar improvements between the treatment groups at 12-month follow-up as assessed by the iBODE score, a composite disease severity measure incorporating body mass index, airflow obstruction, dyspnea, and exercise capacity (incremental shuttle walk test), reported Sara Buttery, BSc, a research physiotherapist and PhD candidate at the National Heart and Lung Institute at Imperial College London.

“Until now there had been no direct comparison of the two to inform decision-making when a person seems to be suitable for either. Bronchoscopic lung volume reduction is a less invasive option and is thought to be ‘less risky’ but, until now, there has not been substantial research to support this,” she said at the annual congress of the European Respiratory Society.

Ms. Buttery and colleagues conducted a randomized, controlled, single-blinded superiority trial to see whether LVRS could be superior to BLVR with valves. They enrolled 88 patients (52% male) with a mean age of 64, and randomly assigned them to receive either LVRS (41 patients) or the less-invasive BLVR (47 patients).

As noted before, there were no significant differences in outcomes at 1 year, with similar degrees of improvement between the surgical techniques for both the composite iBODE score (–1.10 for LVRS vs. –0.82 for BLVR, nonsignificant), and for the individual components of the score.

In addition, the treatments were associated with similar reductions in gas trapping, with residual volume percentage predicted –36.1 with LVRS versus –30.5 with BLVR (nonsignificant).

One patient in each group died during the 12 months of follow-up. The death of the patient in the BLVR group was deemed to be treatment related; the death of the patient in the LVRS group was related to a noninfective exacerbation of chronic obstructive pulmonary disease.

Invited discussant Isabelle Opitz, MD, from University Hospital Zürich told Ms. Buttery: “I have to congratulate you for this very first randomized controlled trial comparing both procedures in a superiority design.”

She pointed out, however, that the number of patients lost to follow-up and crossover of some patients randomized to bronchoscopy raised questions about the powering of the study.

“We did a sensitivity analysis to have a look to see if there was any difference between the patients who did return and the ones who didn’t, and there was no difference at baseline between those patients.” Ms. Buttery said.

She noted that follow-up visits were hampered by the COVID-19 pandemic and the inability of many patients to come into the clinic.

Dr. Opitz also asked about COPD Assessment Test (CAT) scores that were included in the trial design but not reported in the presentation. Ms. Buttery said that the CAT results favored the LVRS group, and that the results would be included in a future economic analysis.

“The results from this first randomized controlled trial suggest that BLVR may be a good therapeutic option for those patients for whom either procedure is suitable,” said Alexander Mathioudakis, MD, PhD, from the University of Manchester (England), who was not involved with this study but commented on it in a press statement. “Lung volume reduction surgery is an invasive operation as it requires a small incision to be made in the chest, which is stitched up after the procedure. As such, it has risks associated with surgery and it takes longer to recover from than bronchoscopic lung volume reduction. On the other hand, endobronchial valves placement is also associated with side effects, such as pneumonia, or valve displacement. Therefore, both the safety and effectiveness of the two procedures need to be investigated further, in larger groups of patients, but the results from this trial are very encouraging.”

The study is supported by the U.K. National Institute of Health Research. Ms. Buttery, Dr. Opitz, and Dr. Mathioudakis reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Eosinophil-guided corticosteroid therapy for patients with chronic obstructive pulmonary disease (COPD) is equivalent in efficacy to standard of care therapy, but the eosinophil-guided therapy may help mitigate the harmful side effects associated with even short courses of corticosteroids, investigators said in a primary care–based randomized trial.

Among patients in 14 primary care practices in the United Kingdom who experienced COPD exacerbations, the proportion of patients who experienced treatment failure at day 28 was 27% for those who were randomized to receive prednisolone only when blood eosinophil counts on a point-of-care assay equaled or exceeded 2%, compared with 34% of all patients randomized to standard of care.

The relative risk for treatment failure using the eosinophil-guided approach was 0.82, which did not reach statistical significance, but indicated noninferiority for the biomarker-based dosing method, Mona Bafadhel, MD, of King’s College London, reported on behalf of colleagues in the Stratified Treatment to Reduce Risk in COPD (STARR2) trial.

“The STARR2 trial showed that eosinophil-guided prescription in primary care is safe and is not associated with worsening outcomes. This is the largest primary care multicenter trial, and probably adds another 20% to the literature base for exacerbations in COPD,” she said in an oral abstract presentation at the European Respiratory Society 2022 Congress.

“A personalized endotype-based treatment with oral prednisolone is possible in patients with COPD and I think should be now part of clinical guidelines,” she added.
 

Too much of a good thing

Although systemic corticosteroids are the universal treatment for COPD exacerbations, the drugs are also known to increase harm, with studies showing that cumulative doses of oral corticosteroids in COPD patients is associated with an increased risk for death. In addition, systemic corticosteroids are the third most common cause of adverse events leading to hospitalization, behind only chemotherapy and antibiotic use leading to  Clostridioides difficile infections, Dr. Bafadhel said.

“And of course, corticosteroids are associated with significant harmful effects, including a five-times increased risk of sepsis, three-times increased risk of [venous thromboembolism], and a twice-increased risk of fracture,” she said.

Dr. Bafadhel and colleagues had previously shown in the single-center BEAT-COPD study that peripheral blood eosinophils at the time of a moderate COPD exacerbation could be used to safely direct oral corticosteroid therapy. She also pointed to a 2019 multicenter open-label study showing that eosinophil-guided care was noninferior to standard prescribing of oral corticosteroids for patients with severe exacerbations.
 

Primary care study

The investigators conducted the current study to test whether eosinophil-guided therapy at the point of care in a primary practice setting was efficacious, with the ultimate goal of encouraging changes in guidelines.

They recruited patients with COPD exacerbations from 14 general practices in Oxfordshire and Buckinghamshire in the Thames Valley.

The patients were randomly assigned to receive either standard of care or the biomarker-guided intervention for 14 days. In this arm, patients with eosinophil counts of 2% or greater received matched prednisolone, while patients with counts below 2% received placebo. The patients were blinded to the assigned drug.

A total of 203 exacerbations among 152 patients were evenly allocated to treatment or control groups. The mean patient age was 71. Of the 102 exacerbations allocated to eosinophil-guided therapy, 34 were treated with placebo.

As noted before, in the intention-to-treat analysis the primary outcome of the treatment failure rate, defined as any need for antibiotics and/or steroids at one month, was 27% in the biomarker-guided arm and 34% in the standard care arm.

“In the per-protocol analysis we also demonstrated that there was a suggestion that there is possible superiority of using blood eosinophil-directed oral corticosteroid prescriptions at the time of acute exacerbation using the point-of-care eosinophil test,” Dr. Bafadhel said.

There were no significant differences in the secondary outcomes of mean change in forced expiratory volume in 1 second (FEV₁), COPD Assessment Test scores from exacerbation to follow-up, and symptoms according to a visual analog scale. 

Invited discussant Dave Singh, MD, of the University of Manchester, England, asked Dr. Bafadhel how the data she presented supported her conclusions about the potential benefits of eosinophil-guided therapy, given that the P values were nonsignificant.

“The primary outcome was powered on noninferiority, and of course what we’ve shown is that it’s not any worse, it’s not any better, but of course it’s the effect of how many courses of steroids you can reduce in that population,” Dr. Bafadhel replied.

She noted that although the investigators have not performed an economic analysis to determine how many adverse events might be avoided using the biomarker-guided approach, “we do know that some of these patients who are given prednisolone, their comorbidities of diabetes worsened, for example.”

In the online Q&A for the presentation, Sohail Ansari, MD, from the Mid and South Essex NHS Foundation Trust in the United Kingdom, said that many patients in primary care practices receive “rescue packs” containing antibiotics and steroids, but may not be equipped to know when they should use the steroids and therefore may overuse them.

“Perhaps community-based, adequately resourced respiratory teams [may] be a way forward, but it will need adequate investment and commitment,” he wrote.

The trial was supported by the University of Oxford and National Institute for Health and Care Research, UK. Dr. Bafadhel reported grant and research support from the National Institute for Health and Care Research, Asthma & Lung UK, AstraZeneca, and Roche, and honoraria or fees from others. Dr. Singh reported speaking fees, honoraria, and research grants from multiple companies. Dr. Ansari reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

Eosinophil-guided corticosteroid therapy for patients with chronic obstructive pulmonary disease (COPD) is equivalent in efficacy to standard of care therapy, but the eosinophil-guided therapy may help mitigate the harmful side effects associated with even short courses of corticosteroids, investigators said in a primary care–based randomized trial.

Among patients in 14 primary care practices in the United Kingdom who experienced COPD exacerbations, the proportion of patients who experienced treatment failure at day 28 was 27% for those who were randomized to receive prednisolone only when blood eosinophil counts on a point-of-care assay equaled or exceeded 2%, compared with 34% of all patients randomized to standard of care.

The relative risk for treatment failure using the eosinophil-guided approach was 0.82, which did not reach statistical significance, but indicated noninferiority for the biomarker-based dosing method, Mona Bafadhel, MD, of King’s College London, reported on behalf of colleagues in the Stratified Treatment to Reduce Risk in COPD (STARR2) trial.

“The STARR2 trial showed that eosinophil-guided prescription in primary care is safe and is not associated with worsening outcomes. This is the largest primary care multicenter trial, and probably adds another 20% to the literature base for exacerbations in COPD,” she said in an oral abstract presentation at the European Respiratory Society 2022 Congress.

“A personalized endotype-based treatment with oral prednisolone is possible in patients with COPD and I think should be now part of clinical guidelines,” she added.
 

Too much of a good thing

Although systemic corticosteroids are the universal treatment for COPD exacerbations, the drugs are also known to increase harm, with studies showing that cumulative doses of oral corticosteroids in COPD patients is associated with an increased risk for death. In addition, systemic corticosteroids are the third most common cause of adverse events leading to hospitalization, behind only chemotherapy and antibiotic use leading to  Clostridioides difficile infections, Dr. Bafadhel said.

“And of course, corticosteroids are associated with significant harmful effects, including a five-times increased risk of sepsis, three-times increased risk of [venous thromboembolism], and a twice-increased risk of fracture,” she said.

Dr. Bafadhel and colleagues had previously shown in the single-center BEAT-COPD study that peripheral blood eosinophils at the time of a moderate COPD exacerbation could be used to safely direct oral corticosteroid therapy. She also pointed to a 2019 multicenter open-label study showing that eosinophil-guided care was noninferior to standard prescribing of oral corticosteroids for patients with severe exacerbations.
 

Primary care study

The investigators conducted the current study to test whether eosinophil-guided therapy at the point of care in a primary practice setting was efficacious, with the ultimate goal of encouraging changes in guidelines.

They recruited patients with COPD exacerbations from 14 general practices in Oxfordshire and Buckinghamshire in the Thames Valley.

The patients were randomly assigned to receive either standard of care or the biomarker-guided intervention for 14 days. In this arm, patients with eosinophil counts of 2% or greater received matched prednisolone, while patients with counts below 2% received placebo. The patients were blinded to the assigned drug.

A total of 203 exacerbations among 152 patients were evenly allocated to treatment or control groups. The mean patient age was 71. Of the 102 exacerbations allocated to eosinophil-guided therapy, 34 were treated with placebo.

As noted before, in the intention-to-treat analysis the primary outcome of the treatment failure rate, defined as any need for antibiotics and/or steroids at one month, was 27% in the biomarker-guided arm and 34% in the standard care arm.

“In the per-protocol analysis we also demonstrated that there was a suggestion that there is possible superiority of using blood eosinophil-directed oral corticosteroid prescriptions at the time of acute exacerbation using the point-of-care eosinophil test,” Dr. Bafadhel said.

There were no significant differences in the secondary outcomes of mean change in forced expiratory volume in 1 second (FEV₁), COPD Assessment Test scores from exacerbation to follow-up, and symptoms according to a visual analog scale. 

Invited discussant Dave Singh, MD, of the University of Manchester, England, asked Dr. Bafadhel how the data she presented supported her conclusions about the potential benefits of eosinophil-guided therapy, given that the P values were nonsignificant.

“The primary outcome was powered on noninferiority, and of course what we’ve shown is that it’s not any worse, it’s not any better, but of course it’s the effect of how many courses of steroids you can reduce in that population,” Dr. Bafadhel replied.

She noted that although the investigators have not performed an economic analysis to determine how many adverse events might be avoided using the biomarker-guided approach, “we do know that some of these patients who are given prednisolone, their comorbidities of diabetes worsened, for example.”

In the online Q&A for the presentation, Sohail Ansari, MD, from the Mid and South Essex NHS Foundation Trust in the United Kingdom, said that many patients in primary care practices receive “rescue packs” containing antibiotics and steroids, but may not be equipped to know when they should use the steroids and therefore may overuse them.

“Perhaps community-based, adequately resourced respiratory teams [may] be a way forward, but it will need adequate investment and commitment,” he wrote.

The trial was supported by the University of Oxford and National Institute for Health and Care Research, UK. Dr. Bafadhel reported grant and research support from the National Institute for Health and Care Research, Asthma & Lung UK, AstraZeneca, and Roche, and honoraria or fees from others. Dr. Singh reported speaking fees, honoraria, and research grants from multiple companies. Dr. Ansari reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

Eosinophil-guided corticosteroid therapy for patients with chronic obstructive pulmonary disease (COPD) is equivalent in efficacy to standard of care therapy, but the eosinophil-guided therapy may help mitigate the harmful side effects associated with even short courses of corticosteroids, investigators said in a primary care–based randomized trial.

Among patients in 14 primary care practices in the United Kingdom who experienced COPD exacerbations, the proportion of patients who experienced treatment failure at day 28 was 27% for those who were randomized to receive prednisolone only when blood eosinophil counts on a point-of-care assay equaled or exceeded 2%, compared with 34% of all patients randomized to standard of care.

The relative risk for treatment failure using the eosinophil-guided approach was 0.82, which did not reach statistical significance, but indicated noninferiority for the biomarker-based dosing method, Mona Bafadhel, MD, of King’s College London, reported on behalf of colleagues in the Stratified Treatment to Reduce Risk in COPD (STARR2) trial.

“The STARR2 trial showed that eosinophil-guided prescription in primary care is safe and is not associated with worsening outcomes. This is the largest primary care multicenter trial, and probably adds another 20% to the literature base for exacerbations in COPD,” she said in an oral abstract presentation at the European Respiratory Society 2022 Congress.

“A personalized endotype-based treatment with oral prednisolone is possible in patients with COPD and I think should be now part of clinical guidelines,” she added.
 

Too much of a good thing

Although systemic corticosteroids are the universal treatment for COPD exacerbations, the drugs are also known to increase harm, with studies showing that cumulative doses of oral corticosteroids in COPD patients is associated with an increased risk for death. In addition, systemic corticosteroids are the third most common cause of adverse events leading to hospitalization, behind only chemotherapy and antibiotic use leading to  Clostridioides difficile infections, Dr. Bafadhel said.

“And of course, corticosteroids are associated with significant harmful effects, including a five-times increased risk of sepsis, three-times increased risk of [venous thromboembolism], and a twice-increased risk of fracture,” she said.

Dr. Bafadhel and colleagues had previously shown in the single-center BEAT-COPD study that peripheral blood eosinophils at the time of a moderate COPD exacerbation could be used to safely direct oral corticosteroid therapy. She also pointed to a 2019 multicenter open-label study showing that eosinophil-guided care was noninferior to standard prescribing of oral corticosteroids for patients with severe exacerbations.
 

Primary care study

The investigators conducted the current study to test whether eosinophil-guided therapy at the point of care in a primary practice setting was efficacious, with the ultimate goal of encouraging changes in guidelines.

They recruited patients with COPD exacerbations from 14 general practices in Oxfordshire and Buckinghamshire in the Thames Valley.

The patients were randomly assigned to receive either standard of care or the biomarker-guided intervention for 14 days. In this arm, patients with eosinophil counts of 2% or greater received matched prednisolone, while patients with counts below 2% received placebo. The patients were blinded to the assigned drug.

A total of 203 exacerbations among 152 patients were evenly allocated to treatment or control groups. The mean patient age was 71. Of the 102 exacerbations allocated to eosinophil-guided therapy, 34 were treated with placebo.

As noted before, in the intention-to-treat analysis the primary outcome of the treatment failure rate, defined as any need for antibiotics and/or steroids at one month, was 27% in the biomarker-guided arm and 34% in the standard care arm.

“In the per-protocol analysis we also demonstrated that there was a suggestion that there is possible superiority of using blood eosinophil-directed oral corticosteroid prescriptions at the time of acute exacerbation using the point-of-care eosinophil test,” Dr. Bafadhel said.

There were no significant differences in the secondary outcomes of mean change in forced expiratory volume in 1 second (FEV₁), COPD Assessment Test scores from exacerbation to follow-up, and symptoms according to a visual analog scale. 

Invited discussant Dave Singh, MD, of the University of Manchester, England, asked Dr. Bafadhel how the data she presented supported her conclusions about the potential benefits of eosinophil-guided therapy, given that the P values were nonsignificant.

“The primary outcome was powered on noninferiority, and of course what we’ve shown is that it’s not any worse, it’s not any better, but of course it’s the effect of how many courses of steroids you can reduce in that population,” Dr. Bafadhel replied.

She noted that although the investigators have not performed an economic analysis to determine how many adverse events might be avoided using the biomarker-guided approach, “we do know that some of these patients who are given prednisolone, their comorbidities of diabetes worsened, for example.”

In the online Q&A for the presentation, Sohail Ansari, MD, from the Mid and South Essex NHS Foundation Trust in the United Kingdom, said that many patients in primary care practices receive “rescue packs” containing antibiotics and steroids, but may not be equipped to know when they should use the steroids and therefore may overuse them.

“Perhaps community-based, adequately resourced respiratory teams [may] be a way forward, but it will need adequate investment and commitment,” he wrote.

The trial was supported by the University of Oxford and National Institute for Health and Care Research, UK. Dr. Bafadhel reported grant and research support from the National Institute for Health and Care Research, Asthma & Lung UK, AstraZeneca, and Roche, and honoraria or fees from others. Dr. Singh reported speaking fees, honoraria, and research grants from multiple companies. Dr. Ansari reported no conflicts of interest.

A version of this article first appeared on Medscape.com.

Current or former smokers who have clinically significant respiratory symptoms but no spirometric evidence of airway obstruction are often treated with dual bronchodilators commonly prescribed for patients with chronic obstructive pulmonary disease (COPD).

But as results of the randomized RETHINC (Redefining Therapy In Early COPD for the Pulmonary Trials Cooperative) trial showed, bronchodilator therapy was no better than placebo at reducing respiratory symptoms in smokers, reported MeiLan K. Han, MD, from the University of Michigan, Ann Arbor, on behalf of colleagues in the RETHINC study group.

“Many tobacco-exposed symptomatic individuals are currently being treated. We don’t know if this is because physicians just aren’t doing spirometry and assuming COPD or they strongly believe that there’s a benefit, but the bottom line is that we really need to do spirometry to understand who benefits from bronchodilators, and we need further research to understand how to treat this specific group of patients because there truly is pathogenesis and disease burden,” Dr. Han said in an oral abstract presentation at the annual congress of the European Respiratory Society.

The study results were also published online in the New England Journal of Medicine to coincide with the presentation.

In an editorial accompanying the study, Don D. Sin, MD, MPH, from the University of British Columbia, Vancouver, commented that the study shows that “long-acting bronchodilators do not appear to be effective for the treatment of symptomatic persons with a smoking history and preserved lung function on spirometry; these medications should most likely be reserved for patients with COPD who have clinically significant airflow limitation,” and that “respiratory symptoms in tobacco-exposed persons are common but are highly variable over time.”

Dave Singh, MD, from the University of Manchester (England), the invited discussant, called it “a very important negative study.”
 

Not up to GOLD standard

Current or former smokers who are symptomatic, with COPD Assessment Test (CAT) scores of at least 10 despite having preserved function on spirometry, have been shown to have higher prospective rates of respiratory disease exacerbations and increased sputum total mucin concentrations. Approximately 43% of such patients are treated with bronchodilators, and 23% are treated with inhaled corticosteroids (ICS), Dr. Han noted.

Her group hypothesized that ever-smokers with spirometric values that fall within the normal range – that is, a postbronchodilator FEV1/FVC ratio of 70 or greater – would still derive benefit from long-acting bronchodilator therapy, even though these patients are currently excluded from Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations.

To test this, they conducted a 12-week, multicenter, randomized, parallel-group study in which patients were assigned to receive either indacaterol (27.5 mcg) and glycopyrrolate (15.6 mcg) inhaled twice daily or placebo.

They enrolled adults aged 40-80 years with a minimum of 10 pack-years of smoking history, postbronchodilator FEV₁/FVC ratio of 70 or greater, and CAT scores of 10 or greater. Patients with known concomitant lung disease, a primary diagnosis of asthma, or body mass index lower than 15 or higher than 40 and those being concomitantly treated with long-acting beta₂-agonists or muscarinic antagonists or a short-acting combination were excluded, although patients were allowed to be on a short-acting beta-agonist.

A total of 535 participants were randomized, but COVID-19 pandemic–imposed obstacles resulted in a modified intention-to-treat population of 277 patients assigned to receive the active treatment and 244 assigned to receive placebo.

There was no difference between the groups for the primary outcome of an at least 4-point decrease in St. George’s Respiratory Questionnaire scores in patients who did not experience treatment failure, defined as an increase in respiratory symptoms requiring treatment with active long-acting bronchodilators or ICS.

The primary endpoint was seen in 56.4% of patients in the bronchodilator group, and 59% of controls.

Although there was greater improvement in pulmonary function from baseline in the treatment group, compared with the placebo group, the improvements did not correlate with similar improvements in symptoms, Dr. Han said.

There were 4 serious adverse events in the bronchodilator group and 11 in the placebo group, but none of the events were deemed to be related to the assigned treatments.

Dr. Han acknowledged limitations of the study, which may have included symptoms driven by other factors such as cardiac disease, suggesting that if such patients had been identified and excluded, a stronger effect might have been seen for the active treatment.

In addition, the study was underpowered to look at the subgroup of participants with chronic bronchitis, and the 12 weeks of the study may have been too short to see improvements in symptoms.

In his editorial, Dr. Sin noted that the study showed that cough and sputum production rather than exertion dyspnea are the primary symptoms among ever-smokers.

“Although bronchodilators are effective in ameliorating breathlessness and improving exercise tolerance, they are generally ineffective for cough,” he wrote. “Existing drugs for the treatment of COPD, such as inhaled glucocorticoids or phosphodiesterase-4 inhibitors, or new therapeutics such as P2X3 receptor antagonists may be more effective for the treatment of cough and sputum production related to smoking and could be considered for future evaluations in this patient population.”

The study was supported by the National Heart, Lung, and Blood Institute, the National Center for Advancing Translational Sciences, and Sunovion Pharmaceuticals. Novartis Pharmaceuticals donated the trial medication and placebo. Dr. Han disclosed grant/research support and honoraria or consulting fees from various companies. Dr. Singh reported speaking fees, honoraria, and research grants from multiple companies. Dr. Sin reported having no conflicts of interest to disclose.

A version of this article first appeared on Medscape.com.

Current or former smokers who have clinically significant respiratory symptoms but no spirometric evidence of airway obstruction are often treated with dual bronchodilators commonly prescribed for patients with chronic obstructive pulmonary disease (COPD).

But as results of the randomized RETHINC (Redefining Therapy In Early COPD for the Pulmonary Trials Cooperative) trial showed, bronchodilator therapy was no better than placebo at reducing respiratory symptoms in smokers, reported MeiLan K. Han, MD, from the University of Michigan, Ann Arbor, on behalf of colleagues in the RETHINC study group.

“Many tobacco-exposed symptomatic individuals are currently being treated. We don’t know if this is because physicians just aren’t doing spirometry and assuming COPD or they strongly believe that there’s a benefit, but the bottom line is that we really need to do spirometry to understand who benefits from bronchodilators, and we need further research to understand how to treat this specific group of patients because there truly is pathogenesis and disease burden,” Dr. Han said in an oral abstract presentation at the annual congress of the European Respiratory Society.

The study results were also published online in the New England Journal of Medicine to coincide with the presentation.

In an editorial accompanying the study, Don D. Sin, MD, MPH, from the University of British Columbia, Vancouver, commented that the study shows that “long-acting bronchodilators do not appear to be effective for the treatment of symptomatic persons with a smoking history and preserved lung function on spirometry; these medications should most likely be reserved for patients with COPD who have clinically significant airflow limitation,” and that “respiratory symptoms in tobacco-exposed persons are common but are highly variable over time.”

Dave Singh, MD, from the University of Manchester (England), the invited discussant, called it “a very important negative study.”
 

Not up to GOLD standard

Current or former smokers who are symptomatic, with COPD Assessment Test (CAT) scores of at least 10 despite having preserved function on spirometry, have been shown to have higher prospective rates of respiratory disease exacerbations and increased sputum total mucin concentrations. Approximately 43% of such patients are treated with bronchodilators, and 23% are treated with inhaled corticosteroids (ICS), Dr. Han noted.

Her group hypothesized that ever-smokers with spirometric values that fall within the normal range – that is, a postbronchodilator FEV1/FVC ratio of 70 or greater – would still derive benefit from long-acting bronchodilator therapy, even though these patients are currently excluded from Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations.

To test this, they conducted a 12-week, multicenter, randomized, parallel-group study in which patients were assigned to receive either indacaterol (27.5 mcg) and glycopyrrolate (15.6 mcg) inhaled twice daily or placebo.

They enrolled adults aged 40-80 years with a minimum of 10 pack-years of smoking history, postbronchodilator FEV₁/FVC ratio of 70 or greater, and CAT scores of 10 or greater. Patients with known concomitant lung disease, a primary diagnosis of asthma, or body mass index lower than 15 or higher than 40 and those being concomitantly treated with long-acting beta₂-agonists or muscarinic antagonists or a short-acting combination were excluded, although patients were allowed to be on a short-acting beta-agonist.

A total of 535 participants were randomized, but COVID-19 pandemic–imposed obstacles resulted in a modified intention-to-treat population of 277 patients assigned to receive the active treatment and 244 assigned to receive placebo.

There was no difference between the groups for the primary outcome of an at least 4-point decrease in St. George’s Respiratory Questionnaire scores in patients who did not experience treatment failure, defined as an increase in respiratory symptoms requiring treatment with active long-acting bronchodilators or ICS.

The primary endpoint was seen in 56.4% of patients in the bronchodilator group, and 59% of controls.

Although there was greater improvement in pulmonary function from baseline in the treatment group, compared with the placebo group, the improvements did not correlate with similar improvements in symptoms, Dr. Han said.

There were 4 serious adverse events in the bronchodilator group and 11 in the placebo group, but none of the events were deemed to be related to the assigned treatments.

Dr. Han acknowledged limitations of the study, which may have included symptoms driven by other factors such as cardiac disease, suggesting that if such patients had been identified and excluded, a stronger effect might have been seen for the active treatment.

In addition, the study was underpowered to look at the subgroup of participants with chronic bronchitis, and the 12 weeks of the study may have been too short to see improvements in symptoms.

In his editorial, Dr. Sin noted that the study showed that cough and sputum production rather than exertion dyspnea are the primary symptoms among ever-smokers.

“Although bronchodilators are effective in ameliorating breathlessness and improving exercise tolerance, they are generally ineffective for cough,” he wrote. “Existing drugs for the treatment of COPD, such as inhaled glucocorticoids or phosphodiesterase-4 inhibitors, or new therapeutics such as P2X3 receptor antagonists may be more effective for the treatment of cough and sputum production related to smoking and could be considered for future evaluations in this patient population.”

The study was supported by the National Heart, Lung, and Blood Institute, the National Center for Advancing Translational Sciences, and Sunovion Pharmaceuticals. Novartis Pharmaceuticals donated the trial medication and placebo. Dr. Han disclosed grant/research support and honoraria or consulting fees from various companies. Dr. Singh reported speaking fees, honoraria, and research grants from multiple companies. Dr. Sin reported having no conflicts of interest to disclose.

A version of this article first appeared on Medscape.com.

Current or former smokers who have clinically significant respiratory symptoms but no spirometric evidence of airway obstruction are often treated with dual bronchodilators commonly prescribed for patients with chronic obstructive pulmonary disease (COPD).

But as results of the randomized RETHINC (Redefining Therapy In Early COPD for the Pulmonary Trials Cooperative) trial showed, bronchodilator therapy was no better than placebo at reducing respiratory symptoms in smokers, reported MeiLan K. Han, MD, from the University of Michigan, Ann Arbor, on behalf of colleagues in the RETHINC study group.

“Many tobacco-exposed symptomatic individuals are currently being treated. We don’t know if this is because physicians just aren’t doing spirometry and assuming COPD or they strongly believe that there’s a benefit, but the bottom line is that we really need to do spirometry to understand who benefits from bronchodilators, and we need further research to understand how to treat this specific group of patients because there truly is pathogenesis and disease burden,” Dr. Han said in an oral abstract presentation at the annual congress of the European Respiratory Society.

The study results were also published online in the New England Journal of Medicine to coincide with the presentation.

In an editorial accompanying the study, Don D. Sin, MD, MPH, from the University of British Columbia, Vancouver, commented that the study shows that “long-acting bronchodilators do not appear to be effective for the treatment of symptomatic persons with a smoking history and preserved lung function on spirometry; these medications should most likely be reserved for patients with COPD who have clinically significant airflow limitation,” and that “respiratory symptoms in tobacco-exposed persons are common but are highly variable over time.”

Dave Singh, MD, from the University of Manchester (England), the invited discussant, called it “a very important negative study.”
 

Not up to GOLD standard

Current or former smokers who are symptomatic, with COPD Assessment Test (CAT) scores of at least 10 despite having preserved function on spirometry, have been shown to have higher prospective rates of respiratory disease exacerbations and increased sputum total mucin concentrations. Approximately 43% of such patients are treated with bronchodilators, and 23% are treated with inhaled corticosteroids (ICS), Dr. Han noted.

Her group hypothesized that ever-smokers with spirometric values that fall within the normal range – that is, a postbronchodilator FEV1/FVC ratio of 70 or greater – would still derive benefit from long-acting bronchodilator therapy, even though these patients are currently excluded from Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations.

To test this, they conducted a 12-week, multicenter, randomized, parallel-group study in which patients were assigned to receive either indacaterol (27.5 mcg) and glycopyrrolate (15.6 mcg) inhaled twice daily or placebo.

They enrolled adults aged 40-80 years with a minimum of 10 pack-years of smoking history, postbronchodilator FEV₁/FVC ratio of 70 or greater, and CAT scores of 10 or greater. Patients with known concomitant lung disease, a primary diagnosis of asthma, or body mass index lower than 15 or higher than 40 and those being concomitantly treated with long-acting beta₂-agonists or muscarinic antagonists or a short-acting combination were excluded, although patients were allowed to be on a short-acting beta-agonist.

A total of 535 participants were randomized, but COVID-19 pandemic–imposed obstacles resulted in a modified intention-to-treat population of 277 patients assigned to receive the active treatment and 244 assigned to receive placebo.

There was no difference between the groups for the primary outcome of an at least 4-point decrease in St. George’s Respiratory Questionnaire scores in patients who did not experience treatment failure, defined as an increase in respiratory symptoms requiring treatment with active long-acting bronchodilators or ICS.

The primary endpoint was seen in 56.4% of patients in the bronchodilator group, and 59% of controls.

Although there was greater improvement in pulmonary function from baseline in the treatment group, compared with the placebo group, the improvements did not correlate with similar improvements in symptoms, Dr. Han said.

There were 4 serious adverse events in the bronchodilator group and 11 in the placebo group, but none of the events were deemed to be related to the assigned treatments.

Dr. Han acknowledged limitations of the study, which may have included symptoms driven by other factors such as cardiac disease, suggesting that if such patients had been identified and excluded, a stronger effect might have been seen for the active treatment.

In addition, the study was underpowered to look at the subgroup of participants with chronic bronchitis, and the 12 weeks of the study may have been too short to see improvements in symptoms.

In his editorial, Dr. Sin noted that the study showed that cough and sputum production rather than exertion dyspnea are the primary symptoms among ever-smokers.

“Although bronchodilators are effective in ameliorating breathlessness and improving exercise tolerance, they are generally ineffective for cough,” he wrote. “Existing drugs for the treatment of COPD, such as inhaled glucocorticoids or phosphodiesterase-4 inhibitors, or new therapeutics such as P2X3 receptor antagonists may be more effective for the treatment of cough and sputum production related to smoking and could be considered for future evaluations in this patient population.”

The study was supported by the National Heart, Lung, and Blood Institute, the National Center for Advancing Translational Sciences, and Sunovion Pharmaceuticals. Novartis Pharmaceuticals donated the trial medication and placebo. Dr. Han disclosed grant/research support and honoraria or consulting fees from various companies. Dr. Singh reported speaking fees, honoraria, and research grants from multiple companies. Dr. Sin reported having no conflicts of interest to disclose.

A version of this article first appeared on Medscape.com.

Lower levels of serum sclerostin (SOST) were significantly associated with increased risk of lung exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD), based on data from 139 individuals.

COPD exacerbations contribute to poorer prognosis and diminished quality of life, but many potential triggers of these exacerbations, including serum biomarkers, have not been well studied, wrote Carlos A. Amado, MD, of Hospital Universitario Marqués de Valdecilla, Santander, Spain, and colleagues.

These biomarkers include sclerostin, which is associated with bone metabolism and may play a role in “muscle-bone crosstalk,” thereby impacting lung function, they said.

In a study published in Pulmonology, the researchers recruited 139 adult outpatients with stable COPD and normal kidney function who were treated at a single center. The patients were followed for 12 months after study enrollment and a baseline assessment of serum SOST, bone metabolism parameters, body composition, clinical characteristics, and lung function. The mean age of the participants was 65.8 years, and 71% were men. Notably, 41.7% of the participants were current smokers. Body composition was assessed using fat-free mass index (FFMI), and lung function was assessed using forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC).

A total of 55 patients had SOST levels of 20 pmol/L at baseline, and 84 had SOST levels greater than 20 pmol/L. In a multivariate analysis, only age and FFMI were positively correlated with SOST levels (beta = 0.264 and beta = 1.241, respectively).

Patients in the lower tertile of SOST levels had a significantly higher risk of moderate COPD exacerbation (hazard ratio, 2.015; P = .017) and hospital admission related to COPD (HR, 5.142; P = .015), compared with the other patients. Also in a multivariate analysis, low levels of SOST were independently associated with FFMI (odds ratio, 1.936; P = .004) but not with any of the other variables.

“We can only speculate about the possible causes and effects of low SOST in COPD,” the researchers wrote in their discussion. However, “we found that SOST and FFMI were positively associated in patients with COPD; therefore, lower levels of circulating SOST might reflect sarcopenia,” they noted. Low levels of muscle mass are associated with COPD exacerbations, they added.

The study findings were limited by several factors, including the use of patients from only one center and the high prevalence of hypovitaminosis D in the study population. The study also was not designed to show causality, the researchers said.

However, the results were strengthened by their specific design and overall well-selected population, as well as the evaluation of bone metabolism, they said.

The study offers the first evidence of an association between SOST and clinical outcomes in COPD “and may have a role as a biomarker to evaluate the risk of exacerbation and hospitalization in COPD,” but more research is needed in other populations to fully evaluate the therapeutic aspects of the study findings, the researchers concluded.

The study was supported by the Instituto de Investigación Sanitaria of Cantabria. The researchers disclosed no financial conflicts.

A version of this article first appeared on Medscape.com.

Lower levels of serum sclerostin (SOST) were significantly associated with increased risk of lung exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD), based on data from 139 individuals.

COPD exacerbations contribute to poorer prognosis and diminished quality of life, but many potential triggers of these exacerbations, including serum biomarkers, have not been well studied, wrote Carlos A. Amado, MD, of Hospital Universitario Marqués de Valdecilla, Santander, Spain, and colleagues.

These biomarkers include sclerostin, which is associated with bone metabolism and may play a role in “muscle-bone crosstalk,” thereby impacting lung function, they said.

In a study published in Pulmonology, the researchers recruited 139 adult outpatients with stable COPD and normal kidney function who were treated at a single center. The patients were followed for 12 months after study enrollment and a baseline assessment of serum SOST, bone metabolism parameters, body composition, clinical characteristics, and lung function. The mean age of the participants was 65.8 years, and 71% were men. Notably, 41.7% of the participants were current smokers. Body composition was assessed using fat-free mass index (FFMI), and lung function was assessed using forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC).

A total of 55 patients had SOST levels of 20 pmol/L at baseline, and 84 had SOST levels greater than 20 pmol/L. In a multivariate analysis, only age and FFMI were positively correlated with SOST levels (beta = 0.264 and beta = 1.241, respectively).

Patients in the lower tertile of SOST levels had a significantly higher risk of moderate COPD exacerbation (hazard ratio, 2.015; P = .017) and hospital admission related to COPD (HR, 5.142; P = .015), compared with the other patients. Also in a multivariate analysis, low levels of SOST were independently associated with FFMI (odds ratio, 1.936; P = .004) but not with any of the other variables.

“We can only speculate about the possible causes and effects of low SOST in COPD,” the researchers wrote in their discussion. However, “we found that SOST and FFMI were positively associated in patients with COPD; therefore, lower levels of circulating SOST might reflect sarcopenia,” they noted. Low levels of muscle mass are associated with COPD exacerbations, they added.

The study findings were limited by several factors, including the use of patients from only one center and the high prevalence of hypovitaminosis D in the study population. The study also was not designed to show causality, the researchers said.

However, the results were strengthened by their specific design and overall well-selected population, as well as the evaluation of bone metabolism, they said.

The study offers the first evidence of an association between SOST and clinical outcomes in COPD “and may have a role as a biomarker to evaluate the risk of exacerbation and hospitalization in COPD,” but more research is needed in other populations to fully evaluate the therapeutic aspects of the study findings, the researchers concluded.

The study was supported by the Instituto de Investigación Sanitaria of Cantabria. The researchers disclosed no financial conflicts.

A version of this article first appeared on Medscape.com.

Lower levels of serum sclerostin (SOST) were significantly associated with increased risk of lung exacerbations and hospitalizations in adults with chronic obstructive pulmonary disease (COPD), based on data from 139 individuals.

COPD exacerbations contribute to poorer prognosis and diminished quality of life, but many potential triggers of these exacerbations, including serum biomarkers, have not been well studied, wrote Carlos A. Amado, MD, of Hospital Universitario Marqués de Valdecilla, Santander, Spain, and colleagues.

These biomarkers include sclerostin, which is associated with bone metabolism and may play a role in “muscle-bone crosstalk,” thereby impacting lung function, they said.

In a study published in Pulmonology, the researchers recruited 139 adult outpatients with stable COPD and normal kidney function who were treated at a single center. The patients were followed for 12 months after study enrollment and a baseline assessment of serum SOST, bone metabolism parameters, body composition, clinical characteristics, and lung function. The mean age of the participants was 65.8 years, and 71% were men. Notably, 41.7% of the participants were current smokers. Body composition was assessed using fat-free mass index (FFMI), and lung function was assessed using forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC).

A total of 55 patients had SOST levels of 20 pmol/L at baseline, and 84 had SOST levels greater than 20 pmol/L. In a multivariate analysis, only age and FFMI were positively correlated with SOST levels (beta = 0.264 and beta = 1.241, respectively).

Patients in the lower tertile of SOST levels had a significantly higher risk of moderate COPD exacerbation (hazard ratio, 2.015; P = .017) and hospital admission related to COPD (HR, 5.142; P = .015), compared with the other patients. Also in a multivariate analysis, low levels of SOST were independently associated with FFMI (odds ratio, 1.936; P = .004) but not with any of the other variables.

“We can only speculate about the possible causes and effects of low SOST in COPD,” the researchers wrote in their discussion. However, “we found that SOST and FFMI were positively associated in patients with COPD; therefore, lower levels of circulating SOST might reflect sarcopenia,” they noted. Low levels of muscle mass are associated with COPD exacerbations, they added.

The study findings were limited by several factors, including the use of patients from only one center and the high prevalence of hypovitaminosis D in the study population. The study also was not designed to show causality, the researchers said.

However, the results were strengthened by their specific design and overall well-selected population, as well as the evaluation of bone metabolism, they said.

The study offers the first evidence of an association between SOST and clinical outcomes in COPD “and may have a role as a biomarker to evaluate the risk of exacerbation and hospitalization in COPD,” but more research is needed in other populations to fully evaluate the therapeutic aspects of the study findings, the researchers concluded.

The study was supported by the Instituto de Investigación Sanitaria of Cantabria. The researchers disclosed no financial conflicts.

A version of this article first appeared on Medscape.com.

A home-based strength training program does not improve dyspnea in patients with chronic obstructive lung disease (COPD), but it does improve some functional capacity and helps patients feel better, a 12-month long HOMEX exercise program shows. 

“Home-based programs became increasingly popular in the last years and complement traditional center-based inpatient and outpatient PR (pulmonary rehabilitation),” Anja Frei, PhD, University of Zurich, Switzerland, and colleagues reported.

“Our study showed that the HOMEX strength training program had no effect on dyspnea after 12 months in persons with COPD who completed PR, [but] the program improved functional exercise capacity ... and many participants reported having perceived positive effects that they attributed to the training,” investigators add.

The study was published online  in the journal CHEST.
 

Intervention or controls

A total of 123 patients (mean age, 67 years) with COPD were randomly assigned to the intervention group or to the control group. The mean forced expiratory volume in 1 second (FEV1) was 39.3% of predicted. Three-quarters of participants had severe or very severe COPD.

A total of 104 patients completed the 12-month study. “The primary outcome was change in dyspnea (Chronic Respiratory Questionnaire, CRQ) from baseline to 12 months,” investigators note. Secondary outcomes included change in exercise capacity as assessed by the 1-minute-sit-to-stand test (1-min-STST); the 6-minute walk test (6MWT); health-related quality of life, exacerbations, and symptoms.

The HOMEX program was a structured, home-based strength training program developed for patients with COPD that could be done following the pulmonary rehabilitation program, with the intention of maintaining the training benefits gained during pulmonary rehabilitation.

“We deliberately focused on the strength component of exercise training due to the fact that skeletal muscle dysfunction is prevalent in COPD and [is] associated with lower daily physical activity and poor prognosis,” the authors explain. Patients had completed pulmonary rehabilitation no longer than 1 month prior to starting the training program. The program required a chair and a set of resistance bands and consisted of trunk, upper limb, and lower limb exercises done at different intensity levels.

Participants were instructed to do the exercises 6 days per week for about 20 minutes per day over the 12-month study interval. The dyspnea score dropped from 4.65 to 4.42 from baseline to 12 months in the intervention group, compared with a drop from 4.61 to 4.06 in the control group, the investigators reported. “There was no evidence for a difference between the two groups in change in the 6MWT distance after 12 months ... but moderate evidence for a between-group difference in the change of repetitions in the 1-min-STST favoring the IG (intervention group),” they also noted, at an adjusted mean difference of 2.6 (95% confidence interval, 0.22-5.03, P = .033).

In all other outcomes, no differences were observed between the two groups. Importantly, 70% of participants carried on with the HOMEX training program until study endpoint and at least 79% of them persevered for at least 10 months. Based on results from a satisfaction survey, 81% of participants randomly assigned to the intervention group indicated that they “liked” or “very much liked” participating in the program, and 79% of them reported that they experienced positive effects that they felt were attributed to the training.

“The program was safe and the majority of the multimorbid and severely ill study participants adhered to the training during the study year,” the authors write. And while the program had no effect on functional exercise capacity as measured by the 6MWT, it did improve the strength and intramuscular coordination of the lower leg muscles because the program had repetitive sit-to-stand exercises as a component of the training. “Adherence to this long-term training program was surprisingly high,” the authors say. “It was well accepted by COPD patients and may facilitate continued training at home.”

One limitation of the study was that some participants did not travel to the rehabilitation clinic for a follow-up assessment.

The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A home-based strength training program does not improve dyspnea in patients with chronic obstructive lung disease (COPD), but it does improve some functional capacity and helps patients feel better, a 12-month long HOMEX exercise program shows. 

“Home-based programs became increasingly popular in the last years and complement traditional center-based inpatient and outpatient PR (pulmonary rehabilitation),” Anja Frei, PhD, University of Zurich, Switzerland, and colleagues reported.

“Our study showed that the HOMEX strength training program had no effect on dyspnea after 12 months in persons with COPD who completed PR, [but] the program improved functional exercise capacity ... and many participants reported having perceived positive effects that they attributed to the training,” investigators add.

The study was published online  in the journal CHEST.
 

Intervention or controls

A total of 123 patients (mean age, 67 years) with COPD were randomly assigned to the intervention group or to the control group. The mean forced expiratory volume in 1 second (FEV1) was 39.3% of predicted. Three-quarters of participants had severe or very severe COPD.

A total of 104 patients completed the 12-month study. “The primary outcome was change in dyspnea (Chronic Respiratory Questionnaire, CRQ) from baseline to 12 months,” investigators note. Secondary outcomes included change in exercise capacity as assessed by the 1-minute-sit-to-stand test (1-min-STST); the 6-minute walk test (6MWT); health-related quality of life, exacerbations, and symptoms.

The HOMEX program was a structured, home-based strength training program developed for patients with COPD that could be done following the pulmonary rehabilitation program, with the intention of maintaining the training benefits gained during pulmonary rehabilitation.

“We deliberately focused on the strength component of exercise training due to the fact that skeletal muscle dysfunction is prevalent in COPD and [is] associated with lower daily physical activity and poor prognosis,” the authors explain. Patients had completed pulmonary rehabilitation no longer than 1 month prior to starting the training program. The program required a chair and a set of resistance bands and consisted of trunk, upper limb, and lower limb exercises done at different intensity levels.

Participants were instructed to do the exercises 6 days per week for about 20 minutes per day over the 12-month study interval. The dyspnea score dropped from 4.65 to 4.42 from baseline to 12 months in the intervention group, compared with a drop from 4.61 to 4.06 in the control group, the investigators reported. “There was no evidence for a difference between the two groups in change in the 6MWT distance after 12 months ... but moderate evidence for a between-group difference in the change of repetitions in the 1-min-STST favoring the IG (intervention group),” they also noted, at an adjusted mean difference of 2.6 (95% confidence interval, 0.22-5.03, P = .033).

In all other outcomes, no differences were observed between the two groups. Importantly, 70% of participants carried on with the HOMEX training program until study endpoint and at least 79% of them persevered for at least 10 months. Based on results from a satisfaction survey, 81% of participants randomly assigned to the intervention group indicated that they “liked” or “very much liked” participating in the program, and 79% of them reported that they experienced positive effects that they felt were attributed to the training.

“The program was safe and the majority of the multimorbid and severely ill study participants adhered to the training during the study year,” the authors write. And while the program had no effect on functional exercise capacity as measured by the 6MWT, it did improve the strength and intramuscular coordination of the lower leg muscles because the program had repetitive sit-to-stand exercises as a component of the training. “Adherence to this long-term training program was surprisingly high,” the authors say. “It was well accepted by COPD patients and may facilitate continued training at home.”

One limitation of the study was that some participants did not travel to the rehabilitation clinic for a follow-up assessment.

The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A home-based strength training program does not improve dyspnea in patients with chronic obstructive lung disease (COPD), but it does improve some functional capacity and helps patients feel better, a 12-month long HOMEX exercise program shows. 

“Home-based programs became increasingly popular in the last years and complement traditional center-based inpatient and outpatient PR (pulmonary rehabilitation),” Anja Frei, PhD, University of Zurich, Switzerland, and colleagues reported.

“Our study showed that the HOMEX strength training program had no effect on dyspnea after 12 months in persons with COPD who completed PR, [but] the program improved functional exercise capacity ... and many participants reported having perceived positive effects that they attributed to the training,” investigators add.

The study was published online  in the journal CHEST.
 

Intervention or controls

A total of 123 patients (mean age, 67 years) with COPD were randomly assigned to the intervention group or to the control group. The mean forced expiratory volume in 1 second (FEV1) was 39.3% of predicted. Three-quarters of participants had severe or very severe COPD.

A total of 104 patients completed the 12-month study. “The primary outcome was change in dyspnea (Chronic Respiratory Questionnaire, CRQ) from baseline to 12 months,” investigators note. Secondary outcomes included change in exercise capacity as assessed by the 1-minute-sit-to-stand test (1-min-STST); the 6-minute walk test (6MWT); health-related quality of life, exacerbations, and symptoms.

The HOMEX program was a structured, home-based strength training program developed for patients with COPD that could be done following the pulmonary rehabilitation program, with the intention of maintaining the training benefits gained during pulmonary rehabilitation.

“We deliberately focused on the strength component of exercise training due to the fact that skeletal muscle dysfunction is prevalent in COPD and [is] associated with lower daily physical activity and poor prognosis,” the authors explain. Patients had completed pulmonary rehabilitation no longer than 1 month prior to starting the training program. The program required a chair and a set of resistance bands and consisted of trunk, upper limb, and lower limb exercises done at different intensity levels.

Participants were instructed to do the exercises 6 days per week for about 20 minutes per day over the 12-month study interval. The dyspnea score dropped from 4.65 to 4.42 from baseline to 12 months in the intervention group, compared with a drop from 4.61 to 4.06 in the control group, the investigators reported. “There was no evidence for a difference between the two groups in change in the 6MWT distance after 12 months ... but moderate evidence for a between-group difference in the change of repetitions in the 1-min-STST favoring the IG (intervention group),” they also noted, at an adjusted mean difference of 2.6 (95% confidence interval, 0.22-5.03, P = .033).

In all other outcomes, no differences were observed between the two groups. Importantly, 70% of participants carried on with the HOMEX training program until study endpoint and at least 79% of them persevered for at least 10 months. Based on results from a satisfaction survey, 81% of participants randomly assigned to the intervention group indicated that they “liked” or “very much liked” participating in the program, and 79% of them reported that they experienced positive effects that they felt were attributed to the training.

“The program was safe and the majority of the multimorbid and severely ill study participants adhered to the training during the study year,” the authors write. And while the program had no effect on functional exercise capacity as measured by the 6MWT, it did improve the strength and intramuscular coordination of the lower leg muscles because the program had repetitive sit-to-stand exercises as a component of the training. “Adherence to this long-term training program was surprisingly high,” the authors say. “It was well accepted by COPD patients and may facilitate continued training at home.”

One limitation of the study was that some participants did not travel to the rehabilitation clinic for a follow-up assessment.

The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A study aimed at determining whether behind some of the sex differences in chronic obstructive airway disease (COPD) prevalence and clinical outcomes lie structural differences in airways found that airway lumen sizes quantified through chest CT were smaller in women than in men.

The findings, published in Radiology, took into account height and lung size. The lower baseline airway lumen sizes in women conferred lower reserves against respiratory morbidity and mortality for equivalent changes, compared with men.

Alfred Pasieka/Science Source

Among key findings in a secondary analysis of consecutive participants (9,363 ever-smokers and 420 never-smokers) enrolled in the Genetic Epidemiology of COPD (COPDGene) study, airway lumen dimensions were lower in never-smoker women than in men (segmental lumen diameter, 8.1 mm vs. 9.1 mm; P < .001). Also, ever-smoker women had narrower segmental lumen diameter (7.8 mm ± 0.05 vs. 8.7 mm ± 0.04; P < .001). The investigators found also that a unit change in wall thickness or lumen area resulted in more severe airflow obstruction, more dyspnea, worse respiratory quality of life, lower 6-minute walk distance, and worse survival in women, compared with men.

While COPD is diagnosed more often in men than women, changes in smoking behavior and increasing urbanization have led to COPD prevalence in women fast approaching the rate in men. Although age-adjusted rates for COPD-related deaths have continued to decline in men, in women they have not. Indeed, never-smoking women accounted for two-thirds of COPD in a population-based study.

COPDGene, a prospective, multicenter, observational cohort study, enrolled current and former smokers, as well as never-smokers, aged 45-80 years at 21 clinical centers across the United States from January 2008 to June 2011 with longitudinal follow-up until November 2020. The investigators quantified airway disease through CT imaging using the following metrics: airway wall thickness of segmental airways, wall area percent of segmental airways, the square root of the wall area of a hypothetical airway with 10-mm internal perimeter, total airway count, lumen diameter of segmental airways, airway volume, and airway fractal dimension.

“Not all sex differences in prevalence of COPD have been explained, and structural differences may explain some of these differences. Our findings may have implications for patient selection for clinical trials,” corresponding author Surya P. Bhatt, MD, associate professor of medicine and director of the University of Alabama Imaging Core at Birmingham, said in an interview.

The investigators wrote: “Our findings have implications for airflow limitation and the consequent clinical outcomes. ... We confirmed that men have more emphysema than women with equivalent smoking burden, and our results suggest that the lower reserve conferred by smaller airways predisposes women to develop airflow limitation predominantly through the airway phenotype. All airway remodeling changes were associated with more dyspnea, worse respiratory quality of life, and lower functional capacity in women than in men. The smaller airways in women can result in higher airway resistance and more turbulent airflow, and thus place a higher ventilatory constraint during exertion. Alteration in each airway measure was also associated with worse survival in women than in men, partially explaining the comparable mortality between the sexes for COPD despite the differing degrees of emphysema.”

“I think these findings highlight underappreciated sex differences in the natural history of COPD,” Mohsen Sadatsafavi, MD, PhD, associate professor, faculty of pharmaceutical sciences, at the University of British Columbia, Vancouver, said in an interview. “To me, first and foremost, the Bhatt et al. findings highlight how the ‘one size fits all’ approach to COPD management of using exacerbation history alone to guide preventive therapies is incorrect. These findings have the potential to change the management paradigm of COPD in the long term, but before getting there, I think we need to relate these findings to clinically relevant and patient-reported outcomes.”

Noting study limitations, the authors stated that a higher proportion of men were active smokers, compared with women, and despite adjustments for smoking status, some of the airway wall differences may be from the impact of active cigarette smoking on airway wall thickness.

Five study authors reported receiving support from various government and industry sources and disclosed conflicts of interest based on relationships with industry. The rest reported no conflicts of interest.

A study aimed at determining whether behind some of the sex differences in chronic obstructive airway disease (COPD) prevalence and clinical outcomes lie structural differences in airways found that airway lumen sizes quantified through chest CT were smaller in women than in men.

The findings, published in Radiology, took into account height and lung size. The lower baseline airway lumen sizes in women conferred lower reserves against respiratory morbidity and mortality for equivalent changes, compared with men.

Alfred Pasieka/Science Source

Among key findings in a secondary analysis of consecutive participants (9,363 ever-smokers and 420 never-smokers) enrolled in the Genetic Epidemiology of COPD (COPDGene) study, airway lumen dimensions were lower in never-smoker women than in men (segmental lumen diameter, 8.1 mm vs. 9.1 mm; P < .001). Also, ever-smoker women had narrower segmental lumen diameter (7.8 mm ± 0.05 vs. 8.7 mm ± 0.04; P < .001). The investigators found also that a unit change in wall thickness or lumen area resulted in more severe airflow obstruction, more dyspnea, worse respiratory quality of life, lower 6-minute walk distance, and worse survival in women, compared with men.

While COPD is diagnosed more often in men than women, changes in smoking behavior and increasing urbanization have led to COPD prevalence in women fast approaching the rate in men. Although age-adjusted rates for COPD-related deaths have continued to decline in men, in women they have not. Indeed, never-smoking women accounted for two-thirds of COPD in a population-based study.

COPDGene, a prospective, multicenter, observational cohort study, enrolled current and former smokers, as well as never-smokers, aged 45-80 years at 21 clinical centers across the United States from January 2008 to June 2011 with longitudinal follow-up until November 2020. The investigators quantified airway disease through CT imaging using the following metrics: airway wall thickness of segmental airways, wall area percent of segmental airways, the square root of the wall area of a hypothetical airway with 10-mm internal perimeter, total airway count, lumen diameter of segmental airways, airway volume, and airway fractal dimension.

“Not all sex differences in prevalence of COPD have been explained, and structural differences may explain some of these differences. Our findings may have implications for patient selection for clinical trials,” corresponding author Surya P. Bhatt, MD, associate professor of medicine and director of the University of Alabama Imaging Core at Birmingham, said in an interview.

The investigators wrote: “Our findings have implications for airflow limitation and the consequent clinical outcomes. ... We confirmed that men have more emphysema than women with equivalent smoking burden, and our results suggest that the lower reserve conferred by smaller airways predisposes women to develop airflow limitation predominantly through the airway phenotype. All airway remodeling changes were associated with more dyspnea, worse respiratory quality of life, and lower functional capacity in women than in men. The smaller airways in women can result in higher airway resistance and more turbulent airflow, and thus place a higher ventilatory constraint during exertion. Alteration in each airway measure was also associated with worse survival in women than in men, partially explaining the comparable mortality between the sexes for COPD despite the differing degrees of emphysema.”

“I think these findings highlight underappreciated sex differences in the natural history of COPD,” Mohsen Sadatsafavi, MD, PhD, associate professor, faculty of pharmaceutical sciences, at the University of British Columbia, Vancouver, said in an interview. “To me, first and foremost, the Bhatt et al. findings highlight how the ‘one size fits all’ approach to COPD management of using exacerbation history alone to guide preventive therapies is incorrect. These findings have the potential to change the management paradigm of COPD in the long term, but before getting there, I think we need to relate these findings to clinically relevant and patient-reported outcomes.”

Noting study limitations, the authors stated that a higher proportion of men were active smokers, compared with women, and despite adjustments for smoking status, some of the airway wall differences may be from the impact of active cigarette smoking on airway wall thickness.

Five study authors reported receiving support from various government and industry sources and disclosed conflicts of interest based on relationships with industry. The rest reported no conflicts of interest.

A study aimed at determining whether behind some of the sex differences in chronic obstructive airway disease (COPD) prevalence and clinical outcomes lie structural differences in airways found that airway lumen sizes quantified through chest CT were smaller in women than in men.

The findings, published in Radiology, took into account height and lung size. The lower baseline airway lumen sizes in women conferred lower reserves against respiratory morbidity and mortality for equivalent changes, compared with men.

Alfred Pasieka/Science Source

Among key findings in a secondary analysis of consecutive participants (9,363 ever-smokers and 420 never-smokers) enrolled in the Genetic Epidemiology of COPD (COPDGene) study, airway lumen dimensions were lower in never-smoker women than in men (segmental lumen diameter, 8.1 mm vs. 9.1 mm; P < .001). Also, ever-smoker women had narrower segmental lumen diameter (7.8 mm ± 0.05 vs. 8.7 mm ± 0.04; P < .001). The investigators found also that a unit change in wall thickness or lumen area resulted in more severe airflow obstruction, more dyspnea, worse respiratory quality of life, lower 6-minute walk distance, and worse survival in women, compared with men.

While COPD is diagnosed more often in men than women, changes in smoking behavior and increasing urbanization have led to COPD prevalence in women fast approaching the rate in men. Although age-adjusted rates for COPD-related deaths have continued to decline in men, in women they have not. Indeed, never-smoking women accounted for two-thirds of COPD in a population-based study.

COPDGene, a prospective, multicenter, observational cohort study, enrolled current and former smokers, as well as never-smokers, aged 45-80 years at 21 clinical centers across the United States from January 2008 to June 2011 with longitudinal follow-up until November 2020. The investigators quantified airway disease through CT imaging using the following metrics: airway wall thickness of segmental airways, wall area percent of segmental airways, the square root of the wall area of a hypothetical airway with 10-mm internal perimeter, total airway count, lumen diameter of segmental airways, airway volume, and airway fractal dimension.

“Not all sex differences in prevalence of COPD have been explained, and structural differences may explain some of these differences. Our findings may have implications for patient selection for clinical trials,” corresponding author Surya P. Bhatt, MD, associate professor of medicine and director of the University of Alabama Imaging Core at Birmingham, said in an interview.

The investigators wrote: “Our findings have implications for airflow limitation and the consequent clinical outcomes. ... We confirmed that men have more emphysema than women with equivalent smoking burden, and our results suggest that the lower reserve conferred by smaller airways predisposes women to develop airflow limitation predominantly through the airway phenotype. All airway remodeling changes were associated with more dyspnea, worse respiratory quality of life, and lower functional capacity in women than in men. The smaller airways in women can result in higher airway resistance and more turbulent airflow, and thus place a higher ventilatory constraint during exertion. Alteration in each airway measure was also associated with worse survival in women than in men, partially explaining the comparable mortality between the sexes for COPD despite the differing degrees of emphysema.”

“I think these findings highlight underappreciated sex differences in the natural history of COPD,” Mohsen Sadatsafavi, MD, PhD, associate professor, faculty of pharmaceutical sciences, at the University of British Columbia, Vancouver, said in an interview. “To me, first and foremost, the Bhatt et al. findings highlight how the ‘one size fits all’ approach to COPD management of using exacerbation history alone to guide preventive therapies is incorrect. These findings have the potential to change the management paradigm of COPD in the long term, but before getting there, I think we need to relate these findings to clinically relevant and patient-reported outcomes.”

Noting study limitations, the authors stated that a higher proportion of men were active smokers, compared with women, and despite adjustments for smoking status, some of the airway wall differences may be from the impact of active cigarette smoking on airway wall thickness.

Five study authors reported receiving support from various government and industry sources and disclosed conflicts of interest based on relationships with industry. The rest reported no conflicts of interest.

Chronic obstructive pulmonary disease (COPD) is defined by airway obstruction and alveolar damage caused by exposure to noxious air particles. The physiologic results include varying degrees of gas-exchange abnormality and mechanical respiratory limitation, often in the form of dynamic hyperinflation. There’s a third major contributor, though – skeletal muscle deconditioning. Only one of these abnormalities responds to inhalers.

When your patients with COPD report dyspnea or exercise intolerance, what do you do? Do you attempt to determine its character to pinpoint its origin? Do you quiz them about their baseline activity levels to quantify their conditioning? I bet you get right to the point and order a cardiopulmonary exercise test (CPET). That way you’ll be able to tease out all the contributors. Nah. Most likely you add an inhaler before continuing to rush through your COPD quality metrics: Vaccines? Check. Lung cancer screening? Check. Smoking cessation? Check.

The physiology of dyspnea and exercise limitation in COPD has been extensively studied. Work-of-breathing, dynamic hyperinflation, and gas-exchange inefficiencies interact with each other in complex ways to produce symptoms. The presence of deconditioning simply magnifies the existing abnormalities within the respiratory system by creating more strain at lower work rates. Acute exacerbations (AECOPD) and oral corticosteroids further aggravate skeletal muscle dysfunction.

The Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) Report directs clinicians to use inhalers to manage dyspnea. If they’re already on one inhaler, they get another. This continues until they’re stabilized on a long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS). The GOLD report also advises pulmonary rehabilitation for any patient with grade B through D disease. Unfortunately, the pulmonary rehabilitation recommendation is buried in the text and doesn’t appear within the popularized pharmacologic algorithms in the report’s figures.

The data for adding inhalers on top of each other to reduce AECOPD and improve overall quality of life (QOL) are good. However, although GOLD tells us to keep adding inhalers for the dyspneic patient with COPD, the authors acknowledge that this hasn’t been systematically tested. It’s important to remember that GOLD is a “statement” as opposed to a clinical practice guideline. The difference? A statement doesn’t require the same formal, rigorous scientific analysis known as the GRADE approach. Using this kind of analysis, a recent clinical practice guideline by the American Thoracic Society found no benefit in dyspnea or respiratory QOL with step-up from inhaler monotherapy.

Inhalers won’t do anything for gas-exchange inefficiencies and deconditioning, at least not directly. A recent CPET study from the CanCOLD network found ventilatory inefficiency in 23% of GOLD 1 and 26% of GOLD 2-4 COPD patients. The numbers were higher for those who reported dyspnea. Skeletal muscle dysfunction rates are equally high.

Thus, dyspnea and exercise intolerance are major determinants of QOL in COPD, but inhalers will only get you so far. At a minimum, make sure you get an activity/exercise history from your patients with COPD. For those who are sedentary, provide an exercise prescription (really, it’s not that hard to do). If dyspnea persists despite LABA or LAMA monotherapy, clarify the complaint before doubling down. Finally, try to get the patient into a good pulmonary rehabilitation program. They’ll thank you afterwards.

Dr. Holley is Associate Professor, department of medicine, Uniformed Services University of the Health Sciences and Program Director, Pulmonary and Critical Care Medical Fellowship, department of medicine, Walter Reed National Military Medical Center, both in Bethesda, Md. He reported receiving research grants from Fisher-Paykel and receiving income from the American College of Chest Physicians.

A version of this article first appeared on Medscape.com.

Chronic obstructive pulmonary disease (COPD) is defined by airway obstruction and alveolar damage caused by exposure to noxious air particles. The physiologic results include varying degrees of gas-exchange abnormality and mechanical respiratory limitation, often in the form of dynamic hyperinflation. There’s a third major contributor, though – skeletal muscle deconditioning. Only one of these abnormalities responds to inhalers.

When your patients with COPD report dyspnea or exercise intolerance, what do you do? Do you attempt to determine its character to pinpoint its origin? Do you quiz them about their baseline activity levels to quantify their conditioning? I bet you get right to the point and order a cardiopulmonary exercise test (CPET). That way you’ll be able to tease out all the contributors. Nah. Most likely you add an inhaler before continuing to rush through your COPD quality metrics: Vaccines? Check. Lung cancer screening? Check. Smoking cessation? Check.

The physiology of dyspnea and exercise limitation in COPD has been extensively studied. Work-of-breathing, dynamic hyperinflation, and gas-exchange inefficiencies interact with each other in complex ways to produce symptoms. The presence of deconditioning simply magnifies the existing abnormalities within the respiratory system by creating more strain at lower work rates. Acute exacerbations (AECOPD) and oral corticosteroids further aggravate skeletal muscle dysfunction.

The Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) Report directs clinicians to use inhalers to manage dyspnea. If they’re already on one inhaler, they get another. This continues until they’re stabilized on a long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS). The GOLD report also advises pulmonary rehabilitation for any patient with grade B through D disease. Unfortunately, the pulmonary rehabilitation recommendation is buried in the text and doesn’t appear within the popularized pharmacologic algorithms in the report’s figures.

The data for adding inhalers on top of each other to reduce AECOPD and improve overall quality of life (QOL) are good. However, although GOLD tells us to keep adding inhalers for the dyspneic patient with COPD, the authors acknowledge that this hasn’t been systematically tested. It’s important to remember that GOLD is a “statement” as opposed to a clinical practice guideline. The difference? A statement doesn’t require the same formal, rigorous scientific analysis known as the GRADE approach. Using this kind of analysis, a recent clinical practice guideline by the American Thoracic Society found no benefit in dyspnea or respiratory QOL with step-up from inhaler monotherapy.

Inhalers won’t do anything for gas-exchange inefficiencies and deconditioning, at least not directly. A recent CPET study from the CanCOLD network found ventilatory inefficiency in 23% of GOLD 1 and 26% of GOLD 2-4 COPD patients. The numbers were higher for those who reported dyspnea. Skeletal muscle dysfunction rates are equally high.

Thus, dyspnea and exercise intolerance are major determinants of QOL in COPD, but inhalers will only get you so far. At a minimum, make sure you get an activity/exercise history from your patients with COPD. For those who are sedentary, provide an exercise prescription (really, it’s not that hard to do). If dyspnea persists despite LABA or LAMA monotherapy, clarify the complaint before doubling down. Finally, try to get the patient into a good pulmonary rehabilitation program. They’ll thank you afterwards.

Dr. Holley is Associate Professor, department of medicine, Uniformed Services University of the Health Sciences and Program Director, Pulmonary and Critical Care Medical Fellowship, department of medicine, Walter Reed National Military Medical Center, both in Bethesda, Md. He reported receiving research grants from Fisher-Paykel and receiving income from the American College of Chest Physicians.

A version of this article first appeared on Medscape.com.

Chronic obstructive pulmonary disease (COPD) is defined by airway obstruction and alveolar damage caused by exposure to noxious air particles. The physiologic results include varying degrees of gas-exchange abnormality and mechanical respiratory limitation, often in the form of dynamic hyperinflation. There’s a third major contributor, though – skeletal muscle deconditioning. Only one of these abnormalities responds to inhalers.

When your patients with COPD report dyspnea or exercise intolerance, what do you do? Do you attempt to determine its character to pinpoint its origin? Do you quiz them about their baseline activity levels to quantify their conditioning? I bet you get right to the point and order a cardiopulmonary exercise test (CPET). That way you’ll be able to tease out all the contributors. Nah. Most likely you add an inhaler before continuing to rush through your COPD quality metrics: Vaccines? Check. Lung cancer screening? Check. Smoking cessation? Check.

The physiology of dyspnea and exercise limitation in COPD has been extensively studied. Work-of-breathing, dynamic hyperinflation, and gas-exchange inefficiencies interact with each other in complex ways to produce symptoms. The presence of deconditioning simply magnifies the existing abnormalities within the respiratory system by creating more strain at lower work rates. Acute exacerbations (AECOPD) and oral corticosteroids further aggravate skeletal muscle dysfunction.

The Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) Report directs clinicians to use inhalers to manage dyspnea. If they’re already on one inhaler, they get another. This continues until they’re stabilized on a long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS). The GOLD report also advises pulmonary rehabilitation for any patient with grade B through D disease. Unfortunately, the pulmonary rehabilitation recommendation is buried in the text and doesn’t appear within the popularized pharmacologic algorithms in the report’s figures.

The data for adding inhalers on top of each other to reduce AECOPD and improve overall quality of life (QOL) are good. However, although GOLD tells us to keep adding inhalers for the dyspneic patient with COPD, the authors acknowledge that this hasn’t been systematically tested. It’s important to remember that GOLD is a “statement” as opposed to a clinical practice guideline. The difference? A statement doesn’t require the same formal, rigorous scientific analysis known as the GRADE approach. Using this kind of analysis, a recent clinical practice guideline by the American Thoracic Society found no benefit in dyspnea or respiratory QOL with step-up from inhaler monotherapy.

Inhalers won’t do anything for gas-exchange inefficiencies and deconditioning, at least not directly. A recent CPET study from the CanCOLD network found ventilatory inefficiency in 23% of GOLD 1 and 26% of GOLD 2-4 COPD patients. The numbers were higher for those who reported dyspnea. Skeletal muscle dysfunction rates are equally high.

Thus, dyspnea and exercise intolerance are major determinants of QOL in COPD, but inhalers will only get you so far. At a minimum, make sure you get an activity/exercise history from your patients with COPD. For those who are sedentary, provide an exercise prescription (really, it’s not that hard to do). If dyspnea persists despite LABA or LAMA monotherapy, clarify the complaint before doubling down. Finally, try to get the patient into a good pulmonary rehabilitation program. They’ll thank you afterwards.

Dr. Holley is Associate Professor, department of medicine, Uniformed Services University of the Health Sciences and Program Director, Pulmonary and Critical Care Medical Fellowship, department of medicine, Walter Reed National Military Medical Center, both in Bethesda, Md. He reported receiving research grants from Fisher-Paykel and receiving income from the American College of Chest Physicians.

A version of this article first appeared on Medscape.com.

Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.

As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.

Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.

“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”

Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.

The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.

Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
 

A window onto patient burden

According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.

The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.

Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.

Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.

Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.

Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.

Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.

The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”

Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.

At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.

Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.

Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.

Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.

Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.

Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.

Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.

According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.

“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”

The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.

A version of this article first appeared on Medscape.com.

Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.

As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.

Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.

“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”

Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.

The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.

Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
 

A window onto patient burden

According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.

The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.

Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.

Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.

Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.

Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.

Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.

The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”

Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.

At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.

Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.

Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.

Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.

Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.

Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.

Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.

According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.

“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”

The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.

A version of this article first appeared on Medscape.com.

Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best.

As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD.

Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups – a finding that caught the researchers by surprise.

“We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials,” one of the authors, MeiLan Han, MD, a professor of medicine in the division of pulmonary and critical care at the University of Michigan, Ann Arbor, told this news organization. Dr. Han, a volunteer medical spokesperson for the American Lung Association, added that patients “may not be as adherent to medications in real life as they are in clinical trials.”

Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring – settings far different from those in which most primary care physicians practice.

The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.

Real-world evidence can shed light on physicians’ intent and on barriers to following guidelines, as well as important patient factors, such as adherence and good inhaler technique, Barbara Yawn, MD, an adjunct professor in the department of family and community health at the University of Minnesota, Minneapolis, and a coauthor of the study, said in an interview.
 

A window onto patient burden

According to the Centers for Disease Control and Prevention, an estimated $15 million Americans have COPD. Annual costs to the health care system approach $50 billion a year. The death rate for COPD has increased since 1969 as death rates of other major killers in the United States, such as heart disease and cancer, declined, according to a 2015 analysis of death records.

The new study, published in the July/August issue of the Annals of Family Medicine, provides a snapshot of COPD’s toll on patients.

Researchers examined electronic health records of 17,192 patients treated at primary care clinics in five states using a dataset maintained by DARTNet Institute, a nonprofit organization that supports research and quality improvement. They also analyzed self-reported assessments from 1,354 patients in the dataset who are in a registry called Advancing the Patient Experience in COPD.

Over half (56%) of patients were female, White (64%), aged 55-84 years (81%), and current or exsmokers (80%). The vast majority had three or more comorbidities, including hypertension, diabetes, and depression.

Serious flare-ups were common; 38% of patients had experienced one or more exacerbations in the previous year. Of registry respondents, half said they had had at least one exacerbation, and 20% said they had been hospitalized for COPD during that period.

Among patients in the registry, 43% reported that COPD had a high or very high impact on their health, and 45% could not walk at a normal pace without losing their breath.

Almost 90% of patients were receiving a maintenance therapy regimen. The number of exacerbations was “somewhat surprising,” the authors say. They write that the findings may indicate that patients were not receiving appropriate treatment or were not complying with their medication regimens and that there may be a need for nonpharmacologic interventions, such as smoking cessation. They also write that physician education is needed to support earlier diagnosis and treatment so as to delay declines in lung function.

The researchers say their findings highlight “the need for more real-life effectiveness trials to better support decision-making at the primary care level.”

Dr. Yawn is a coinvestigator of one such study, called CAPTURE, which is assessing a screening tool for COPD in primary care practices.

At the University of Illinois, Chicago, Jerry Krishnan, MD, PhD, pulmonologist and professor of medicine and public health, is running the RELIANCE study, which is comparing the use of azithromycin and roflumilast in preventing hospitalization and death among patients with COPD who continue to have exacerbations.

Although RELIANCE involves pulmonologists, Dr. Krishnan told this news organization, it offers a model for building real-world evidence on questions relevant to primary care. “We don’t really know if medications used by patients in my clinic are as effective as reported in clinical trials that were used to obtain regulatory approvals by the U.S. Food and Drug Administration,” he said.

Wilson Pace, MD, a family physician and chief medical officer and chief technology officer of DARTNet, said funders of research are becoming aware of the need for real-world studies along with “gold standard” efficacy trials.

Dr. Pace, who helped conduct the new study, said a remaining obstacle to improving care is “a defeatist attitude of clinicians” who are skeptical about the ability of therapy to have an effect.

Real-world evidence could remedy clinician frustrations, he said. When clinicians are shown that they can improve patients’ quality of life and maybe even reduce the cost of care, “then they will hopefully pay attention,” he said.

Some experts who were not involved in the study said the findings offer an illuminating, although incomplete, picture. Nonpharmacologic interventions, the management of other health problems, and access to specialty care are not addressed, and the researchers didn’t have data on treatment adherence, inhaler technique, and patients’ peak inspiratory flow – factors that influence the effectiveness of medications. The study also lacked information on whether patients received pulmonary rehabilitation to help their heart and lungs work better.

Nicola Hanania, MD, a professor of medicine and director of the Airways Clinical Research Center at Baylor College of Medicine, Houston, said the study “adds a lot to what we have known” but pointed out that COPD is grossly underdiagnosed.

According to one analysis of National Health and Nutrition Examination Surveys, 72% of individuals with COPD don’t know they have the condition. Such patients were not included in the study, Dr. Hanania noted.

“We need pragmatic studies over multiple years to better understand” the condition, Dr. Yawn said. Real-world evidence “based in an academic setting or specialty practices is not sufficient,” she added. “We need to see results from patients and clinics that look like what we have.”

The registry was established and funded by Optimum Patient Care Global, a nonprofit organization, and Boehringer Ingelheim. Dr. Han has consulted for Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca and has received research support from Novartis and Sunovion. Dr. Yawn has served on advisory boards for GlaxoSmithKline, Astra-Zeneca, Novartis, and Boehringer Ingelheim and has received research funds from GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, and Novartis. Dr. Krishnan has disclosed no relevant financial relationshps. Dr. Hanania has received honoraria for serving as consultant or advisory board member for GSK, Boehringer Ingelheim, Novartis, Sanofi, AstraZeneca, Teva, Genentech, and Amgen. His institution has received research grant support on his behalf from GSK, Sanofi, Boehringer Ingelheim, AstraZeneca, Genentech, Teva, and Novartis. Dr. Pace is on the advisory board for Mylan and has received stock from Novo Nordisk, Pfizer, Novartis, Johnson & Johnson, Stryker, Amgen, Gilead, and Sanofi.

A version of this article first appeared on Medscape.com.