Combo Treatment Beneficial in Moderate to Severe COPD

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ORLANDO – A combination of fixed-dose mometasone furoate and formoterol fumarate improved lung function in patients with moderate to very severe chronic obstructive pulmonary disease.

The finding came from a 26-week, phase III, multicenter, double-blind, placebo-controlled study of 1,055 adults who were current or former smokers and had a prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity ratio of 0.70 or less. Currently, three combinations of inhaled corticosteroid plus long-acting beta agonists are available for the treatment of COPD, but not this particular combination of mometasone furoate with formoterol fumarate administered with a metered-dose inhaler, which is licensed for asthma treatment in the United States under the name Dulera, Dr. Edward Kerwin said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The patients were randomized to one of five twice-daily metered-dose inhaler treatment arms: mometasone furoate 400 mcg/formoterol 10 mcg (MF400/F10), mometasone furoate 200 mcg/formoterol 10 mcg (MF200/F10), mometasone furoate 400 mcg alone (MF400), formoterol 10 mcg alone (F10), or placebo. A total of 840 of the 1,055 randomized patients completed the treatment period. About 80% of the patients were male, with a mean age of 59 years, and about three-quarters were white. Nearly half were current smokers, and all had smoked at one point in time, with an average of 40 pack-years.

The findings of this study also were published online in the International Journal of Chronic Obstructive Pulmonary Disease (Int. J. Chron. Obstruct. Pulmon. Dis. 2012;7:43-55).

One of the two coprimary endpoints, the contribution of F10 to the MF400/F10 combination at week 13, was reached with a statistically significant 109 mL difference in FEV1 area under the curve, compared with MF 400 alone. The overall effect size was a 163 mL difference for MF400/F10 over placebo at 13 weeks. A comparison of MF 400/F10 with MF 400 monotherapy also demonstrated a statistically significant effect of the F10, with an improvement of 69 mL, reported Dr. Kerwin, of the Clinical Research Institute of Southern Oregon, Medford.

The other coprimary endpoint, the mean change from baseline in morning predose FEV1 at the week 13 endpoint, showed the contribution of the MF component. It was statistically significant for MF400/F10 over F10 alone, at 111 mL, and for MF200/F10 over F10 alone, at 58 mL. An overall effect size of 128 mL was seen for MF400/F10 over placebo.

Among the secondary efficacy variables, the MF 400/F10 group exceeded the 4-point minimum clinically important difference on the St. George’s Respiratory Questionnaire, compared with placebo, with a significant effect size of 4.56 points at week 26. Statistically significant improvements in questionnaire total score for MF400/F10 over placebo were demonstrated at weeks 4, 13, and 26. However, the MF200/F10 dosage did not achieve the minimum clinically important difference, with only a 2.82 reduction, compared with placebo.

The proportion of COPD symptom–free nights improved by 0.15 with MF400/F10, compared with 0.06 for placebo, a significant difference over the 26-week period. However, there was no treatment difference between MF400/F10 and placebo in the proportion of patients with partly stable COPD at 26 weeks, with percentages ranging from 38% to 46% across treatment groups.

Time to first COPD exacerbation significantly improved with MF400/F10 over F10 alone, and an analysis excluding mild exacerbations showed that moderate to severe exacerbations were significantly more frequent with placebo than with MF400/F10, at 16.5% vs. 8.8%, Dr. Kerwin said.

Treatment with MF400/F10 was well tolerated, and the proportion of patients reporting treatment-emergent adverse events during the 26-week treatment period was similar between treatment groups, ranging from 26% in the MF400/F10 group to 33% in the F10 alone group. The most common of these were headache, upper respiratory tract infection, cough, COPD, and hypertension. Pneumonia did not occur in more than 1% in any treatment group. The incidence of oral candidiasis was low, occurring in no more than 2.4% of any group (five of the MF 400 alone patients), he reported.

This study was sponsored by Merck Sharp & Dohme. Dr. Kerwin disclosed that he has received consulting fees and/or speaking fees from Dey Laboratories, GlaxoSmithKline, MAP Pharma (AstraZeneca), Merck, Teva, and Sepracor.

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ORLANDO – A combination of fixed-dose mometasone furoate and formoterol fumarate improved lung function in patients with moderate to very severe chronic obstructive pulmonary disease.

The finding came from a 26-week, phase III, multicenter, double-blind, placebo-controlled study of 1,055 adults who were current or former smokers and had a prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity ratio of 0.70 or less. Currently, three combinations of inhaled corticosteroid plus long-acting beta agonists are available for the treatment of COPD, but not this particular combination of mometasone furoate with formoterol fumarate administered with a metered-dose inhaler, which is licensed for asthma treatment in the United States under the name Dulera, Dr. Edward Kerwin said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The patients were randomized to one of five twice-daily metered-dose inhaler treatment arms: mometasone furoate 400 mcg/formoterol 10 mcg (MF400/F10), mometasone furoate 200 mcg/formoterol 10 mcg (MF200/F10), mometasone furoate 400 mcg alone (MF400), formoterol 10 mcg alone (F10), or placebo. A total of 840 of the 1,055 randomized patients completed the treatment period. About 80% of the patients were male, with a mean age of 59 years, and about three-quarters were white. Nearly half were current smokers, and all had smoked at one point in time, with an average of 40 pack-years.

The findings of this study also were published online in the International Journal of Chronic Obstructive Pulmonary Disease (Int. J. Chron. Obstruct. Pulmon. Dis. 2012;7:43-55).

One of the two coprimary endpoints, the contribution of F10 to the MF400/F10 combination at week 13, was reached with a statistically significant 109 mL difference in FEV1 area under the curve, compared with MF 400 alone. The overall effect size was a 163 mL difference for MF400/F10 over placebo at 13 weeks. A comparison of MF 400/F10 with MF 400 monotherapy also demonstrated a statistically significant effect of the F10, with an improvement of 69 mL, reported Dr. Kerwin, of the Clinical Research Institute of Southern Oregon, Medford.

The other coprimary endpoint, the mean change from baseline in morning predose FEV1 at the week 13 endpoint, showed the contribution of the MF component. It was statistically significant for MF400/F10 over F10 alone, at 111 mL, and for MF200/F10 over F10 alone, at 58 mL. An overall effect size of 128 mL was seen for MF400/F10 over placebo.

Among the secondary efficacy variables, the MF 400/F10 group exceeded the 4-point minimum clinically important difference on the St. George’s Respiratory Questionnaire, compared with placebo, with a significant effect size of 4.56 points at week 26. Statistically significant improvements in questionnaire total score for MF400/F10 over placebo were demonstrated at weeks 4, 13, and 26. However, the MF200/F10 dosage did not achieve the minimum clinically important difference, with only a 2.82 reduction, compared with placebo.

The proportion of COPD symptom–free nights improved by 0.15 with MF400/F10, compared with 0.06 for placebo, a significant difference over the 26-week period. However, there was no treatment difference between MF400/F10 and placebo in the proportion of patients with partly stable COPD at 26 weeks, with percentages ranging from 38% to 46% across treatment groups.

Time to first COPD exacerbation significantly improved with MF400/F10 over F10 alone, and an analysis excluding mild exacerbations showed that moderate to severe exacerbations were significantly more frequent with placebo than with MF400/F10, at 16.5% vs. 8.8%, Dr. Kerwin said.

Treatment with MF400/F10 was well tolerated, and the proportion of patients reporting treatment-emergent adverse events during the 26-week treatment period was similar between treatment groups, ranging from 26% in the MF400/F10 group to 33% in the F10 alone group. The most common of these were headache, upper respiratory tract infection, cough, COPD, and hypertension. Pneumonia did not occur in more than 1% in any treatment group. The incidence of oral candidiasis was low, occurring in no more than 2.4% of any group (five of the MF 400 alone patients), he reported.

This study was sponsored by Merck Sharp & Dohme. Dr. Kerwin disclosed that he has received consulting fees and/or speaking fees from Dey Laboratories, GlaxoSmithKline, MAP Pharma (AstraZeneca), Merck, Teva, and Sepracor.

ORLANDO – A combination of fixed-dose mometasone furoate and formoterol fumarate improved lung function in patients with moderate to very severe chronic obstructive pulmonary disease.

The finding came from a 26-week, phase III, multicenter, double-blind, placebo-controlled study of 1,055 adults who were current or former smokers and had a prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity ratio of 0.70 or less. Currently, three combinations of inhaled corticosteroid plus long-acting beta agonists are available for the treatment of COPD, but not this particular combination of mometasone furoate with formoterol fumarate administered with a metered-dose inhaler, which is licensed for asthma treatment in the United States under the name Dulera, Dr. Edward Kerwin said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The patients were randomized to one of five twice-daily metered-dose inhaler treatment arms: mometasone furoate 400 mcg/formoterol 10 mcg (MF400/F10), mometasone furoate 200 mcg/formoterol 10 mcg (MF200/F10), mometasone furoate 400 mcg alone (MF400), formoterol 10 mcg alone (F10), or placebo. A total of 840 of the 1,055 randomized patients completed the treatment period. About 80% of the patients were male, with a mean age of 59 years, and about three-quarters were white. Nearly half were current smokers, and all had smoked at one point in time, with an average of 40 pack-years.

The findings of this study also were published online in the International Journal of Chronic Obstructive Pulmonary Disease (Int. J. Chron. Obstruct. Pulmon. Dis. 2012;7:43-55).

One of the two coprimary endpoints, the contribution of F10 to the MF400/F10 combination at week 13, was reached with a statistically significant 109 mL difference in FEV1 area under the curve, compared with MF 400 alone. The overall effect size was a 163 mL difference for MF400/F10 over placebo at 13 weeks. A comparison of MF 400/F10 with MF 400 monotherapy also demonstrated a statistically significant effect of the F10, with an improvement of 69 mL, reported Dr. Kerwin, of the Clinical Research Institute of Southern Oregon, Medford.

The other coprimary endpoint, the mean change from baseline in morning predose FEV1 at the week 13 endpoint, showed the contribution of the MF component. It was statistically significant for MF400/F10 over F10 alone, at 111 mL, and for MF200/F10 over F10 alone, at 58 mL. An overall effect size of 128 mL was seen for MF400/F10 over placebo.

Among the secondary efficacy variables, the MF 400/F10 group exceeded the 4-point minimum clinically important difference on the St. George’s Respiratory Questionnaire, compared with placebo, with a significant effect size of 4.56 points at week 26. Statistically significant improvements in questionnaire total score for MF400/F10 over placebo were demonstrated at weeks 4, 13, and 26. However, the MF200/F10 dosage did not achieve the minimum clinically important difference, with only a 2.82 reduction, compared with placebo.

The proportion of COPD symptom–free nights improved by 0.15 with MF400/F10, compared with 0.06 for placebo, a significant difference over the 26-week period. However, there was no treatment difference between MF400/F10 and placebo in the proportion of patients with partly stable COPD at 26 weeks, with percentages ranging from 38% to 46% across treatment groups.

Time to first COPD exacerbation significantly improved with MF400/F10 over F10 alone, and an analysis excluding mild exacerbations showed that moderate to severe exacerbations were significantly more frequent with placebo than with MF400/F10, at 16.5% vs. 8.8%, Dr. Kerwin said.

Treatment with MF400/F10 was well tolerated, and the proportion of patients reporting treatment-emergent adverse events during the 26-week treatment period was similar between treatment groups, ranging from 26% in the MF400/F10 group to 33% in the F10 alone group. The most common of these were headache, upper respiratory tract infection, cough, COPD, and hypertension. Pneumonia did not occur in more than 1% in any treatment group. The incidence of oral candidiasis was low, occurring in no more than 2.4% of any group (five of the MF 400 alone patients), he reported.

This study was sponsored by Merck Sharp & Dohme. Dr. Kerwin disclosed that he has received consulting fees and/or speaking fees from Dey Laboratories, GlaxoSmithKline, MAP Pharma (AstraZeneca), Merck, Teva, and Sepracor.

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Major Finding: The contribution of F10 to the MF400/F10 combination at week 13 was shown by a statistically significant 109 mL difference in FEV1 area under the curve, compared with MF400 alone. The mean change from baseline in morning predose FEV1 at the week 13 endpoint showed the contribution of the MF400 component, with a statistically significant difference of 111 mL between MF400/F10 and F10 alone.

Data Source: The data come from a 26-week, phase III, multicenter, double-blind, placebo-controlled study of 1,055 adults with moderate to very severe COPD.

Disclosures: The study was sponsored by Merck Sharp & Dohme. Dr. Kerwin disclosed that he has received consulting fees and/or speaking fees from Dey Laboratories, GlaxoSmithKline, MAP Pharma (AstraZeneca), Merck, Teva, and Sepracor.

Steroid Exposure Risk High in 'Allergic Triad'

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ORLANDO – Children who have at least two diagnoses of the "allergic triad" – asthma, allergic rhinitis, and atopic dermatitis – often receive prescriptions from multiple physicians and may be at risk for substantial exposure to exogenous corticosteroids.

This finding, from a chart review of 197 pediatric patients seen between 2000 and 2010 at a single U.S. allergy/immunology clinic, "reinforces the need for improved communication and coordination of care," said Dr. Min Jung Lee of Cohen Children’s Medical Center of New York.

Of the 197 patients who had been diagnosed with at least two of the three ICD-9 codes for asthma, allergic rhinitis, and/or atopic dermatitis, 48% had all three conditions. Of the patients diagnosed with two of the three conditions, 67% had both asthma and allergic rhinitis, 16.5% had asthma and atopic dermatitis, and 16.5% had allergic rhinitis and atopic dermatitis, Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of the patients with asthma, 74% were treated with inhaled steroids. Of those, 36% received steroid prescriptions from multiple physicians, 29% from allergists alone, 21% from primary care physicians alone, and 9% from pulmonologists alone. Of the patients with allergic rhinitis, 62% were treated with intranasal steroids, of which 20% were given prescriptions by multiple physicians, 67% by allergists alone, 5% by primary care physicians alone, and 3% by otolaryngologists alone. Of those with atopic dermatitis, 75% were treated with topical steroids; of those, 41% received steroid prescriptions from multiple physicians, 23% from dermatologists alone, 21% from allergists alone, and 7% from primary care physicians alone. (There were small numbers from each group for which the specialty of the prescriber was unknown.)

Among the children with both asthma and allergic rhinitis, 55% were treated with corticosteroids for both conditions and 38% for one of the two conditions, while just 7% were not treated with corticosteroids. For those with asthma and atopic dermatitis, 59% were prescribed corticosteroids for both conditions and 23% for just one of the two, while 18% received no corticosteroids. For the allergic rhinitis plus atopic dermatitis group, 6% were treated with corticosteroids for both conditions and 82% for just one, while 12% received none.

For the 95 patients who had all three conditions, 41% were treated with corticosteroids for all three, 36% for two of the three, and 19% for one of the three. Just 4% of that group was not treated with corticosteroids, Dr. Lee reported.

In response to an audience member’s question about whether the prescriptions were coordinated, she replied, "No, usually we didn’t see any communication between physicians."

In an interview, the study’s principal investigator, Dr. James C. Fagin, noted, "Our concern is the cumulative effect, because there are so many physicians involved and the communication is so poor that the primary care physician may not know what the [specialist] is prescribing, or if the [specialist] changes that prescription to a more potent drug. Without the electronic medical record to cement all of this, it becomes difficult to manage. We are certainly guilty in our speciality because we’re not always notifying the primary care physician every time we change a prescription."

However, "in terms of asthma care, we want the primary care physician to be actively involved, but they aren’t always good at communicating with specialists about changes they make. ... Communication has to go both ways," added Dr. Fagin, director of pediatric allergy and clinical immunology and director of the Center for Childhood Asthma at the Cohen children’s center.

In response to another audience member’s question regarding the role of electronic medical records, Dr. Lee responded that "access to electronic pharmacy records would also be very beneficial for each of us to know what our patients are getting."

Both Dr. Lee and Dr. Fagin stated that they had no disclosures.

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ORLANDO – Children who have at least two diagnoses of the "allergic triad" – asthma, allergic rhinitis, and atopic dermatitis – often receive prescriptions from multiple physicians and may be at risk for substantial exposure to exogenous corticosteroids.

This finding, from a chart review of 197 pediatric patients seen between 2000 and 2010 at a single U.S. allergy/immunology clinic, "reinforces the need for improved communication and coordination of care," said Dr. Min Jung Lee of Cohen Children’s Medical Center of New York.

Of the 197 patients who had been diagnosed with at least two of the three ICD-9 codes for asthma, allergic rhinitis, and/or atopic dermatitis, 48% had all three conditions. Of the patients diagnosed with two of the three conditions, 67% had both asthma and allergic rhinitis, 16.5% had asthma and atopic dermatitis, and 16.5% had allergic rhinitis and atopic dermatitis, Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of the patients with asthma, 74% were treated with inhaled steroids. Of those, 36% received steroid prescriptions from multiple physicians, 29% from allergists alone, 21% from primary care physicians alone, and 9% from pulmonologists alone. Of the patients with allergic rhinitis, 62% were treated with intranasal steroids, of which 20% were given prescriptions by multiple physicians, 67% by allergists alone, 5% by primary care physicians alone, and 3% by otolaryngologists alone. Of those with atopic dermatitis, 75% were treated with topical steroids; of those, 41% received steroid prescriptions from multiple physicians, 23% from dermatologists alone, 21% from allergists alone, and 7% from primary care physicians alone. (There were small numbers from each group for which the specialty of the prescriber was unknown.)

Among the children with both asthma and allergic rhinitis, 55% were treated with corticosteroids for both conditions and 38% for one of the two conditions, while just 7% were not treated with corticosteroids. For those with asthma and atopic dermatitis, 59% were prescribed corticosteroids for both conditions and 23% for just one of the two, while 18% received no corticosteroids. For the allergic rhinitis plus atopic dermatitis group, 6% were treated with corticosteroids for both conditions and 82% for just one, while 12% received none.

For the 95 patients who had all three conditions, 41% were treated with corticosteroids for all three, 36% for two of the three, and 19% for one of the three. Just 4% of that group was not treated with corticosteroids, Dr. Lee reported.

In response to an audience member’s question about whether the prescriptions were coordinated, she replied, "No, usually we didn’t see any communication between physicians."

In an interview, the study’s principal investigator, Dr. James C. Fagin, noted, "Our concern is the cumulative effect, because there are so many physicians involved and the communication is so poor that the primary care physician may not know what the [specialist] is prescribing, or if the [specialist] changes that prescription to a more potent drug. Without the electronic medical record to cement all of this, it becomes difficult to manage. We are certainly guilty in our speciality because we’re not always notifying the primary care physician every time we change a prescription."

However, "in terms of asthma care, we want the primary care physician to be actively involved, but they aren’t always good at communicating with specialists about changes they make. ... Communication has to go both ways," added Dr. Fagin, director of pediatric allergy and clinical immunology and director of the Center for Childhood Asthma at the Cohen children’s center.

In response to another audience member’s question regarding the role of electronic medical records, Dr. Lee responded that "access to electronic pharmacy records would also be very beneficial for each of us to know what our patients are getting."

Both Dr. Lee and Dr. Fagin stated that they had no disclosures.

ORLANDO – Children who have at least two diagnoses of the "allergic triad" – asthma, allergic rhinitis, and atopic dermatitis – often receive prescriptions from multiple physicians and may be at risk for substantial exposure to exogenous corticosteroids.

This finding, from a chart review of 197 pediatric patients seen between 2000 and 2010 at a single U.S. allergy/immunology clinic, "reinforces the need for improved communication and coordination of care," said Dr. Min Jung Lee of Cohen Children’s Medical Center of New York.

Of the 197 patients who had been diagnosed with at least two of the three ICD-9 codes for asthma, allergic rhinitis, and/or atopic dermatitis, 48% had all three conditions. Of the patients diagnosed with two of the three conditions, 67% had both asthma and allergic rhinitis, 16.5% had asthma and atopic dermatitis, and 16.5% had allergic rhinitis and atopic dermatitis, Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of the patients with asthma, 74% were treated with inhaled steroids. Of those, 36% received steroid prescriptions from multiple physicians, 29% from allergists alone, 21% from primary care physicians alone, and 9% from pulmonologists alone. Of the patients with allergic rhinitis, 62% were treated with intranasal steroids, of which 20% were given prescriptions by multiple physicians, 67% by allergists alone, 5% by primary care physicians alone, and 3% by otolaryngologists alone. Of those with atopic dermatitis, 75% were treated with topical steroids; of those, 41% received steroid prescriptions from multiple physicians, 23% from dermatologists alone, 21% from allergists alone, and 7% from primary care physicians alone. (There were small numbers from each group for which the specialty of the prescriber was unknown.)

Among the children with both asthma and allergic rhinitis, 55% were treated with corticosteroids for both conditions and 38% for one of the two conditions, while just 7% were not treated with corticosteroids. For those with asthma and atopic dermatitis, 59% were prescribed corticosteroids for both conditions and 23% for just one of the two, while 18% received no corticosteroids. For the allergic rhinitis plus atopic dermatitis group, 6% were treated with corticosteroids for both conditions and 82% for just one, while 12% received none.

For the 95 patients who had all three conditions, 41% were treated with corticosteroids for all three, 36% for two of the three, and 19% for one of the three. Just 4% of that group was not treated with corticosteroids, Dr. Lee reported.

In response to an audience member’s question about whether the prescriptions were coordinated, she replied, "No, usually we didn’t see any communication between physicians."

In an interview, the study’s principal investigator, Dr. James C. Fagin, noted, "Our concern is the cumulative effect, because there are so many physicians involved and the communication is so poor that the primary care physician may not know what the [specialist] is prescribing, or if the [specialist] changes that prescription to a more potent drug. Without the electronic medical record to cement all of this, it becomes difficult to manage. We are certainly guilty in our speciality because we’re not always notifying the primary care physician every time we change a prescription."

However, "in terms of asthma care, we want the primary care physician to be actively involved, but they aren’t always good at communicating with specialists about changes they make. ... Communication has to go both ways," added Dr. Fagin, director of pediatric allergy and clinical immunology and director of the Center for Childhood Asthma at the Cohen children’s center.

In response to another audience member’s question regarding the role of electronic medical records, Dr. Lee responded that "access to electronic pharmacy records would also be very beneficial for each of us to know what our patients are getting."

Both Dr. Lee and Dr. Fagin stated that they had no disclosures.

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Major Finding: Treatment with corticosteroids for both conditions was found in 55% of children with asthma and allergic rhinitis, 59% of those with asthma and atopic dermatitis, and 6% of those with allergic rhinitis plus atopic dermatitis. In patients who had all three conditions, 41% were treated with corticosteroids for all three and 36% for two of the three.

Data Source: The findings come from a chart review of 197 pediatric patients seen at a single allergy clinic over a 10-year period.

Disclosures: Both Dr. Lee and Dr. Fagin stated that they had no disclosures.

Vitamin D May Boost Fluticasone's Allergic Rhinitis Effect

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ORLANDO – Daily oral treatment with a vitamin D supplement significantly improved the ability of fluticasone nasal spray to relieve the total, daytime symptoms of seasonal rhinitis in a pilot, placebo-controlled study of 35 patients.

Two weeks of daily treatment with 4,000 IU of a standard, over-the-counter vitamin D pill also produced a strong trend toward improving the impact of a standard fluticasone nasal spray on nasal symptoms, and improved rhinoconjunctivitis quality of life, James Lane reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

But because the study population was so small, the next step has to be an attempt to repeat the result in a larger number of patients, said Mr. Lane, a researcher in the department of surgery at the University of Chicago.

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Dr. Fuad M. Baroody

"We were not expecting vitamin D to look this good. The spread [between vitamin D treatment and placebo] was convincing and surprising; the differences we saw at days 2 and 3 were huge. We need to do it again," said Dr. Fuad M. Baroody, a professor of surgery and pediatrics at the University of Chicago and the senior investigator of the study.

"This was a shot in the dark, to see if there was any chance of it working for rhinitis. I hope we’ll get funding [from the National Institutes of Health] because industry won’t fund this," Dr. Baroody said in an interview. He and his associates tested vitamin D because of prior evidence that it can improve immune function.

He said that he has submitted a proposal to the NIH for a four-arm follow-up study: vitamin D alone, fluticasone alone, both agents together, and a double-placebo group. Dr. Baroody added that he has consulted a statistician who calculated that for a four-group study like this that involves multiple between-group comparisons, he would need to enroll about 150 patients into each arm – 600 patients in total – to produce adequate statistical power.

"There is no way we could do that by ourselves. If the government doesn’t fund it, it dies here," he said.

The study enrolled patients who were 18-45 years old and had at least a 2-year history of seasonal allergic rhinitis to tree, grass, or ragweed pollen during the pollen seasons of 2010 and 2011. The patients also needed to have a positive skin-test reaction to one of the pollen types, and had to show at least a 35% improvement in their peak nasal flow following treatment with oxymetazoline, a decongestant.

The researchers had all patients self-administer 100-mcg fluticasone propionate nasal spray into each nostril once daily, and randomized patients to daily oral treatment with 4,000 IU of vitamin D or placebo for 14 days.

The enrolled patients had an average age of about 28 years, with roughly equal numbers of men and women. At baseline, their average level of serum vitamin D was about 30 ng/mL. By the end of the study, the average vitamin D level of the patients randomized to take a daily vitamin D pill had risen to 37 ng/ml, while the average level in the placebo patients had not changed from baseline.

After 2 weeks in the study, the daytime total-symptom score throughout the study period fell by an average of 3.7 points in the placebo group and by 6.9 points in the patients taking vitamin D, a significant statistical difference. The 24-hour, nasal-symptom score throughout the study fell by an average of 7.6 points in the placebo patients and by 11.3 points in the vitamin D group, a difference that approached significance. Both the total symptom scores and nasal symptom scores fell dramatically lower in the vitamin D patients during the first week of the study and then remained low during the second week. In contrast, scores fell more gradually in the placebo patients, but by the final, 14th day of the study average scores in the placebo patients approached those of the patients on vitamin D. This pattern suggested that vitamin D helped hasten patient responses to fluticasone, Dr. Baroody said.

The researchers also measured the patients’ rhinoconjunctivitis quality of life at baseline and after 2 weeks on treatment. This measure fell by an average of 2.0 units in the placebo patients and by an average of 2.5 units in the patients who took vitamin D. With this metric, a reduction of at least 0.5 units is considered clinically meaningful. The results therefore showed that while the patients taking fluticasone alone had a meaningful quality of life improvement, the incrementally better improvement in patients also taking vitamin D was even more clinically meaningful, although the between-group difference of 0.5 units was not significant.

 

 

Mr. Lane and Dr. Baroody said that they had no relevant disclosures.

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ORLANDO – Daily oral treatment with a vitamin D supplement significantly improved the ability of fluticasone nasal spray to relieve the total, daytime symptoms of seasonal rhinitis in a pilot, placebo-controlled study of 35 patients.

Two weeks of daily treatment with 4,000 IU of a standard, over-the-counter vitamin D pill also produced a strong trend toward improving the impact of a standard fluticasone nasal spray on nasal symptoms, and improved rhinoconjunctivitis quality of life, James Lane reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

But because the study population was so small, the next step has to be an attempt to repeat the result in a larger number of patients, said Mr. Lane, a researcher in the department of surgery at the University of Chicago.

Mitchel L. Zoler/IMNG Medical Media
Dr. Fuad M. Baroody

"We were not expecting vitamin D to look this good. The spread [between vitamin D treatment and placebo] was convincing and surprising; the differences we saw at days 2 and 3 were huge. We need to do it again," said Dr. Fuad M. Baroody, a professor of surgery and pediatrics at the University of Chicago and the senior investigator of the study.

"This was a shot in the dark, to see if there was any chance of it working for rhinitis. I hope we’ll get funding [from the National Institutes of Health] because industry won’t fund this," Dr. Baroody said in an interview. He and his associates tested vitamin D because of prior evidence that it can improve immune function.

He said that he has submitted a proposal to the NIH for a four-arm follow-up study: vitamin D alone, fluticasone alone, both agents together, and a double-placebo group. Dr. Baroody added that he has consulted a statistician who calculated that for a four-group study like this that involves multiple between-group comparisons, he would need to enroll about 150 patients into each arm – 600 patients in total – to produce adequate statistical power.

"There is no way we could do that by ourselves. If the government doesn’t fund it, it dies here," he said.

The study enrolled patients who were 18-45 years old and had at least a 2-year history of seasonal allergic rhinitis to tree, grass, or ragweed pollen during the pollen seasons of 2010 and 2011. The patients also needed to have a positive skin-test reaction to one of the pollen types, and had to show at least a 35% improvement in their peak nasal flow following treatment with oxymetazoline, a decongestant.

The researchers had all patients self-administer 100-mcg fluticasone propionate nasal spray into each nostril once daily, and randomized patients to daily oral treatment with 4,000 IU of vitamin D or placebo for 14 days.

The enrolled patients had an average age of about 28 years, with roughly equal numbers of men and women. At baseline, their average level of serum vitamin D was about 30 ng/mL. By the end of the study, the average vitamin D level of the patients randomized to take a daily vitamin D pill had risen to 37 ng/ml, while the average level in the placebo patients had not changed from baseline.

After 2 weeks in the study, the daytime total-symptom score throughout the study period fell by an average of 3.7 points in the placebo group and by 6.9 points in the patients taking vitamin D, a significant statistical difference. The 24-hour, nasal-symptom score throughout the study fell by an average of 7.6 points in the placebo patients and by 11.3 points in the vitamin D group, a difference that approached significance. Both the total symptom scores and nasal symptom scores fell dramatically lower in the vitamin D patients during the first week of the study and then remained low during the second week. In contrast, scores fell more gradually in the placebo patients, but by the final, 14th day of the study average scores in the placebo patients approached those of the patients on vitamin D. This pattern suggested that vitamin D helped hasten patient responses to fluticasone, Dr. Baroody said.

The researchers also measured the patients’ rhinoconjunctivitis quality of life at baseline and after 2 weeks on treatment. This measure fell by an average of 2.0 units in the placebo patients and by an average of 2.5 units in the patients who took vitamin D. With this metric, a reduction of at least 0.5 units is considered clinically meaningful. The results therefore showed that while the patients taking fluticasone alone had a meaningful quality of life improvement, the incrementally better improvement in patients also taking vitamin D was even more clinically meaningful, although the between-group difference of 0.5 units was not significant.

 

 

Mr. Lane and Dr. Baroody said that they had no relevant disclosures.

ORLANDO – Daily oral treatment with a vitamin D supplement significantly improved the ability of fluticasone nasal spray to relieve the total, daytime symptoms of seasonal rhinitis in a pilot, placebo-controlled study of 35 patients.

Two weeks of daily treatment with 4,000 IU of a standard, over-the-counter vitamin D pill also produced a strong trend toward improving the impact of a standard fluticasone nasal spray on nasal symptoms, and improved rhinoconjunctivitis quality of life, James Lane reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

But because the study population was so small, the next step has to be an attempt to repeat the result in a larger number of patients, said Mr. Lane, a researcher in the department of surgery at the University of Chicago.

Mitchel L. Zoler/IMNG Medical Media
Dr. Fuad M. Baroody

"We were not expecting vitamin D to look this good. The spread [between vitamin D treatment and placebo] was convincing and surprising; the differences we saw at days 2 and 3 were huge. We need to do it again," said Dr. Fuad M. Baroody, a professor of surgery and pediatrics at the University of Chicago and the senior investigator of the study.

"This was a shot in the dark, to see if there was any chance of it working for rhinitis. I hope we’ll get funding [from the National Institutes of Health] because industry won’t fund this," Dr. Baroody said in an interview. He and his associates tested vitamin D because of prior evidence that it can improve immune function.

He said that he has submitted a proposal to the NIH for a four-arm follow-up study: vitamin D alone, fluticasone alone, both agents together, and a double-placebo group. Dr. Baroody added that he has consulted a statistician who calculated that for a four-group study like this that involves multiple between-group comparisons, he would need to enroll about 150 patients into each arm – 600 patients in total – to produce adequate statistical power.

"There is no way we could do that by ourselves. If the government doesn’t fund it, it dies here," he said.

The study enrolled patients who were 18-45 years old and had at least a 2-year history of seasonal allergic rhinitis to tree, grass, or ragweed pollen during the pollen seasons of 2010 and 2011. The patients also needed to have a positive skin-test reaction to one of the pollen types, and had to show at least a 35% improvement in their peak nasal flow following treatment with oxymetazoline, a decongestant.

The researchers had all patients self-administer 100-mcg fluticasone propionate nasal spray into each nostril once daily, and randomized patients to daily oral treatment with 4,000 IU of vitamin D or placebo for 14 days.

The enrolled patients had an average age of about 28 years, with roughly equal numbers of men and women. At baseline, their average level of serum vitamin D was about 30 ng/mL. By the end of the study, the average vitamin D level of the patients randomized to take a daily vitamin D pill had risen to 37 ng/ml, while the average level in the placebo patients had not changed from baseline.

After 2 weeks in the study, the daytime total-symptom score throughout the study period fell by an average of 3.7 points in the placebo group and by 6.9 points in the patients taking vitamin D, a significant statistical difference. The 24-hour, nasal-symptom score throughout the study fell by an average of 7.6 points in the placebo patients and by 11.3 points in the vitamin D group, a difference that approached significance. Both the total symptom scores and nasal symptom scores fell dramatically lower in the vitamin D patients during the first week of the study and then remained low during the second week. In contrast, scores fell more gradually in the placebo patients, but by the final, 14th day of the study average scores in the placebo patients approached those of the patients on vitamin D. This pattern suggested that vitamin D helped hasten patient responses to fluticasone, Dr. Baroody said.

The researchers also measured the patients’ rhinoconjunctivitis quality of life at baseline and after 2 weeks on treatment. This measure fell by an average of 2.0 units in the placebo patients and by an average of 2.5 units in the patients who took vitamin D. With this metric, a reduction of at least 0.5 units is considered clinically meaningful. The results therefore showed that while the patients taking fluticasone alone had a meaningful quality of life improvement, the incrementally better improvement in patients also taking vitamin D was even more clinically meaningful, although the between-group difference of 0.5 units was not significant.

 

 

Mr. Lane and Dr. Baroody said that they had no relevant disclosures.

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Traffic Proximity Linked to Adult Asthma

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ORLANDO – High levels of traffic-exhaust exposure at home were linked with an increased risk for asthma or worsening asthma in adults, according to results from two separate, U.S. studies reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In one study, the association occurred exclusively among adults who were also obese, said Dr. Tolly Epstein, an allergy and immunology physician at the University of Cincinnati; the second study did not include a body mass index assessment.

Photo: Dmytro Panchenko/iStockphoto.com
U.S. Environmental Protection Agency regulations phased in during 2007-2010 began to reduce the fine-particle emissions that seem to have the greatest asthma impact. But full compliance with those regulations won’t happen until buses and trucks that were built before 2007 and are still on U.S. highways reach the end of their commercial lives.

Dr. Epstein’s study, which included 104 people aged 65 years or older with asthma, and the second study, which included 20 adults aged 18 or older with asthma who lived in Brooklyn, N.Y., are among the first reported results to link adult asthma with regular exposure to traffic emissions at home.

Results from several prior studies had documented this link in children, but far fewer data exist that show an association in adults, said both Dr. Epstein and Dr. Maria-Anna Vastardi, who reported the Brooklyn results (J. Allergy Clin. Immunol. 2012;129[suppl.]:AB205).

Dr. Tolly Epstein

Both researchers also agreed that, for the time being, there is little that asthma patients or susceptible people who live close to highways or other high-traffic roads can do with this knowledge, short of moving further away from heavy traffic.

"New buses don’t produce as much diesel exhaust," noted Dr. Vastardi, an allergy and immunology physician at Downstate Medical Center in Brooklyn. In addition, Environmental Protection Agency regulations phased in during 2007-2010 began to reduce the fine-particle emissions that seem to have the greatest asthma impact. But full compliance with those regulations won’t happen until buses and trucks that were built before 2007 and are still on U.S. highways reach the end of their commercial lives.

Until then, "the best advice is to move away from highways," Dr. Vastardi said in an interview.

The findings from Dr. Epstein’s study suggest that weight loss might also help.

Dr. Maria-Anna Vastardi

"We don’t know the relationship between obesity, air pollution, and asthma, but results from another study showed the same thing in older adults exposed to ozone," she said. "We know that obesity is a risk factor for poor asthma control in all populations, so losing weight should help."

Another key finding from her study was that the minimum air level of ECAT (elemental carbon attributable to traffic, which is a surrogate marker for diesel-generated particulate exposure) that linked with significantly worse asthma control was 0.39 mcg/m3, strikingly similar to the minimum ECAT exposure level of 0.41 mcg/m3 that prior findings by her Cincinnati associates showed linked with wheezing in 3-year old children (Am. J. Respir. Crit. Care Med. 2009;180:1068-75).

"What’s important is that we now have a level of ECAT exposure that seems to associate with adverse effects" on asthma, Dr. Epstein said in an interview. "It’s something to look at for public health, this level compared with currently accepted ECAT levels."

Her study, "Cincinnati Asthma Severity in Older Adults," included 104 patients from pulmonary and asthma clinics in the Cincinnati area during March 2010-April 2011 who were at least 65 years old. The study excluded patients with chronic obstructive pulmonary disease or heart failure.

Most enrollees had moderate to severe asthma, based on their level of medication

use. Nearly three-quarters were on regular treatment with a long-acting beta agonist as well as an inhaled corticosteroid, and a quarter were on treatment with an inhaled corticosteroid alone. None of the enrolled patients was on a regimen limited to albuterol only. They averaged an FEV1 (forced expiratory volume in 1 second) of 71% prior to treatment with a bronchodilator.

Data on their ECAT exposure came from a series of air samplings made at 27 sites throughout the Cincinnati area during 2001-2006 as part of the Cincinnati Childhood Allergy and Air Pollution Study. This analysis identified 75% of the older asthma patients with a low ECAT exposure at home of 0.38 mcg/m3 or less, and 25% with a high exposure of 0.39 mcg/m3 or greater. During the sampling period, 95% of the patients reported spending an average of 18 hours a day at home.

 

 

When several demographic and clinical variables (including age, sex, race, atopy, and chronic rhinitis) were controlled, the analysis found that high ECAT exposure significantly correlated with poor asthma control, as measured by a questionnaire, and a high number of exacerbations. No such link existed for patients who had lower ECAT exposures.

In addition, high ECAT exposure and poor asthma control were linked only in patients with a body mass index of at least 30 kg/m2, Dr. Epstein said. Obese patients had a fivefold increased rate of poor asthma control, compared with leaner patients.

The results reported by Dr. Vastardi focused on 17 patients with asthma, 25 patients with seasonal rhinoconjunctivitis, and 3 patients with both conditions who were patients at Lutheran Medical Center in Brooklyn. All patients were at least 18 years old, and all lived within 2 miles of a busy, elevated interstate highway in Brooklyn. The study also included 17 healthy adults without asthma or rhinoconjunctivitis who lived in the same area. The average age of all participants was about 40 years, and about 60% were women.

The 45 patients lived an average of 0.28 miles from the highway, compared with an average of 0.57 miles among the controls, a statistically significant difference, Dr. Vastardi reported. A more focused analysis showed that the 17 patients who had only asthma lived an average of about 0.1 miles from the highway, whereas the 25 patients who had only seasonal rhinoconjunctivitis lived an average of about 0.4 miles from the highway, a distance that was not significantly different from the controls.

"Our results indicate that proximity to a heavily trafficked highway correlated with the presence of asthma in adults, but not with seasonal allergy," she said. The results suggest that vehicle emissions "increase the risk for developing inflammatory lung disease" in adults.

Dr. Epstein and Dr. Vastardi said that they had no disclosures.

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ORLANDO – High levels of traffic-exhaust exposure at home were linked with an increased risk for asthma or worsening asthma in adults, according to results from two separate, U.S. studies reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In one study, the association occurred exclusively among adults who were also obese, said Dr. Tolly Epstein, an allergy and immunology physician at the University of Cincinnati; the second study did not include a body mass index assessment.

Photo: Dmytro Panchenko/iStockphoto.com
U.S. Environmental Protection Agency regulations phased in during 2007-2010 began to reduce the fine-particle emissions that seem to have the greatest asthma impact. But full compliance with those regulations won’t happen until buses and trucks that were built before 2007 and are still on U.S. highways reach the end of their commercial lives.

Dr. Epstein’s study, which included 104 people aged 65 years or older with asthma, and the second study, which included 20 adults aged 18 or older with asthma who lived in Brooklyn, N.Y., are among the first reported results to link adult asthma with regular exposure to traffic emissions at home.

Results from several prior studies had documented this link in children, but far fewer data exist that show an association in adults, said both Dr. Epstein and Dr. Maria-Anna Vastardi, who reported the Brooklyn results (J. Allergy Clin. Immunol. 2012;129[suppl.]:AB205).

Dr. Tolly Epstein

Both researchers also agreed that, for the time being, there is little that asthma patients or susceptible people who live close to highways or other high-traffic roads can do with this knowledge, short of moving further away from heavy traffic.

"New buses don’t produce as much diesel exhaust," noted Dr. Vastardi, an allergy and immunology physician at Downstate Medical Center in Brooklyn. In addition, Environmental Protection Agency regulations phased in during 2007-2010 began to reduce the fine-particle emissions that seem to have the greatest asthma impact. But full compliance with those regulations won’t happen until buses and trucks that were built before 2007 and are still on U.S. highways reach the end of their commercial lives.

Until then, "the best advice is to move away from highways," Dr. Vastardi said in an interview.

The findings from Dr. Epstein’s study suggest that weight loss might also help.

Dr. Maria-Anna Vastardi

"We don’t know the relationship between obesity, air pollution, and asthma, but results from another study showed the same thing in older adults exposed to ozone," she said. "We know that obesity is a risk factor for poor asthma control in all populations, so losing weight should help."

Another key finding from her study was that the minimum air level of ECAT (elemental carbon attributable to traffic, which is a surrogate marker for diesel-generated particulate exposure) that linked with significantly worse asthma control was 0.39 mcg/m3, strikingly similar to the minimum ECAT exposure level of 0.41 mcg/m3 that prior findings by her Cincinnati associates showed linked with wheezing in 3-year old children (Am. J. Respir. Crit. Care Med. 2009;180:1068-75).

"What’s important is that we now have a level of ECAT exposure that seems to associate with adverse effects" on asthma, Dr. Epstein said in an interview. "It’s something to look at for public health, this level compared with currently accepted ECAT levels."

Her study, "Cincinnati Asthma Severity in Older Adults," included 104 patients from pulmonary and asthma clinics in the Cincinnati area during March 2010-April 2011 who were at least 65 years old. The study excluded patients with chronic obstructive pulmonary disease or heart failure.

Most enrollees had moderate to severe asthma, based on their level of medication

use. Nearly three-quarters were on regular treatment with a long-acting beta agonist as well as an inhaled corticosteroid, and a quarter were on treatment with an inhaled corticosteroid alone. None of the enrolled patients was on a regimen limited to albuterol only. They averaged an FEV1 (forced expiratory volume in 1 second) of 71% prior to treatment with a bronchodilator.

Data on their ECAT exposure came from a series of air samplings made at 27 sites throughout the Cincinnati area during 2001-2006 as part of the Cincinnati Childhood Allergy and Air Pollution Study. This analysis identified 75% of the older asthma patients with a low ECAT exposure at home of 0.38 mcg/m3 or less, and 25% with a high exposure of 0.39 mcg/m3 or greater. During the sampling period, 95% of the patients reported spending an average of 18 hours a day at home.

 

 

When several demographic and clinical variables (including age, sex, race, atopy, and chronic rhinitis) were controlled, the analysis found that high ECAT exposure significantly correlated with poor asthma control, as measured by a questionnaire, and a high number of exacerbations. No such link existed for patients who had lower ECAT exposures.

In addition, high ECAT exposure and poor asthma control were linked only in patients with a body mass index of at least 30 kg/m2, Dr. Epstein said. Obese patients had a fivefold increased rate of poor asthma control, compared with leaner patients.

The results reported by Dr. Vastardi focused on 17 patients with asthma, 25 patients with seasonal rhinoconjunctivitis, and 3 patients with both conditions who were patients at Lutheran Medical Center in Brooklyn. All patients were at least 18 years old, and all lived within 2 miles of a busy, elevated interstate highway in Brooklyn. The study also included 17 healthy adults without asthma or rhinoconjunctivitis who lived in the same area. The average age of all participants was about 40 years, and about 60% were women.

The 45 patients lived an average of 0.28 miles from the highway, compared with an average of 0.57 miles among the controls, a statistically significant difference, Dr. Vastardi reported. A more focused analysis showed that the 17 patients who had only asthma lived an average of about 0.1 miles from the highway, whereas the 25 patients who had only seasonal rhinoconjunctivitis lived an average of about 0.4 miles from the highway, a distance that was not significantly different from the controls.

"Our results indicate that proximity to a heavily trafficked highway correlated with the presence of asthma in adults, but not with seasonal allergy," she said. The results suggest that vehicle emissions "increase the risk for developing inflammatory lung disease" in adults.

Dr. Epstein and Dr. Vastardi said that they had no disclosures.

ORLANDO – High levels of traffic-exhaust exposure at home were linked with an increased risk for asthma or worsening asthma in adults, according to results from two separate, U.S. studies reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In one study, the association occurred exclusively among adults who were also obese, said Dr. Tolly Epstein, an allergy and immunology physician at the University of Cincinnati; the second study did not include a body mass index assessment.

Photo: Dmytro Panchenko/iStockphoto.com
U.S. Environmental Protection Agency regulations phased in during 2007-2010 began to reduce the fine-particle emissions that seem to have the greatest asthma impact. But full compliance with those regulations won’t happen until buses and trucks that were built before 2007 and are still on U.S. highways reach the end of their commercial lives.

Dr. Epstein’s study, which included 104 people aged 65 years or older with asthma, and the second study, which included 20 adults aged 18 or older with asthma who lived in Brooklyn, N.Y., are among the first reported results to link adult asthma with regular exposure to traffic emissions at home.

Results from several prior studies had documented this link in children, but far fewer data exist that show an association in adults, said both Dr. Epstein and Dr. Maria-Anna Vastardi, who reported the Brooklyn results (J. Allergy Clin. Immunol. 2012;129[suppl.]:AB205).

Dr. Tolly Epstein

Both researchers also agreed that, for the time being, there is little that asthma patients or susceptible people who live close to highways or other high-traffic roads can do with this knowledge, short of moving further away from heavy traffic.

"New buses don’t produce as much diesel exhaust," noted Dr. Vastardi, an allergy and immunology physician at Downstate Medical Center in Brooklyn. In addition, Environmental Protection Agency regulations phased in during 2007-2010 began to reduce the fine-particle emissions that seem to have the greatest asthma impact. But full compliance with those regulations won’t happen until buses and trucks that were built before 2007 and are still on U.S. highways reach the end of their commercial lives.

Until then, "the best advice is to move away from highways," Dr. Vastardi said in an interview.

The findings from Dr. Epstein’s study suggest that weight loss might also help.

Dr. Maria-Anna Vastardi

"We don’t know the relationship between obesity, air pollution, and asthma, but results from another study showed the same thing in older adults exposed to ozone," she said. "We know that obesity is a risk factor for poor asthma control in all populations, so losing weight should help."

Another key finding from her study was that the minimum air level of ECAT (elemental carbon attributable to traffic, which is a surrogate marker for diesel-generated particulate exposure) that linked with significantly worse asthma control was 0.39 mcg/m3, strikingly similar to the minimum ECAT exposure level of 0.41 mcg/m3 that prior findings by her Cincinnati associates showed linked with wheezing in 3-year old children (Am. J. Respir. Crit. Care Med. 2009;180:1068-75).

"What’s important is that we now have a level of ECAT exposure that seems to associate with adverse effects" on asthma, Dr. Epstein said in an interview. "It’s something to look at for public health, this level compared with currently accepted ECAT levels."

Her study, "Cincinnati Asthma Severity in Older Adults," included 104 patients from pulmonary and asthma clinics in the Cincinnati area during March 2010-April 2011 who were at least 65 years old. The study excluded patients with chronic obstructive pulmonary disease or heart failure.

Most enrollees had moderate to severe asthma, based on their level of medication

use. Nearly three-quarters were on regular treatment with a long-acting beta agonist as well as an inhaled corticosteroid, and a quarter were on treatment with an inhaled corticosteroid alone. None of the enrolled patients was on a regimen limited to albuterol only. They averaged an FEV1 (forced expiratory volume in 1 second) of 71% prior to treatment with a bronchodilator.

Data on their ECAT exposure came from a series of air samplings made at 27 sites throughout the Cincinnati area during 2001-2006 as part of the Cincinnati Childhood Allergy and Air Pollution Study. This analysis identified 75% of the older asthma patients with a low ECAT exposure at home of 0.38 mcg/m3 or less, and 25% with a high exposure of 0.39 mcg/m3 or greater. During the sampling period, 95% of the patients reported spending an average of 18 hours a day at home.

 

 

When several demographic and clinical variables (including age, sex, race, atopy, and chronic rhinitis) were controlled, the analysis found that high ECAT exposure significantly correlated with poor asthma control, as measured by a questionnaire, and a high number of exacerbations. No such link existed for patients who had lower ECAT exposures.

In addition, high ECAT exposure and poor asthma control were linked only in patients with a body mass index of at least 30 kg/m2, Dr. Epstein said. Obese patients had a fivefold increased rate of poor asthma control, compared with leaner patients.

The results reported by Dr. Vastardi focused on 17 patients with asthma, 25 patients with seasonal rhinoconjunctivitis, and 3 patients with both conditions who were patients at Lutheran Medical Center in Brooklyn. All patients were at least 18 years old, and all lived within 2 miles of a busy, elevated interstate highway in Brooklyn. The study also included 17 healthy adults without asthma or rhinoconjunctivitis who lived in the same area. The average age of all participants was about 40 years, and about 60% were women.

The 45 patients lived an average of 0.28 miles from the highway, compared with an average of 0.57 miles among the controls, a statistically significant difference, Dr. Vastardi reported. A more focused analysis showed that the 17 patients who had only asthma lived an average of about 0.1 miles from the highway, whereas the 25 patients who had only seasonal rhinoconjunctivitis lived an average of about 0.4 miles from the highway, a distance that was not significantly different from the controls.

"Our results indicate that proximity to a heavily trafficked highway correlated with the presence of asthma in adults, but not with seasonal allergy," she said. The results suggest that vehicle emissions "increase the risk for developing inflammatory lung disease" in adults.

Dr. Epstein and Dr. Vastardi said that they had no disclosures.

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Major Finding: Moderate to severe asthma or poorly controlled asthma in adult patients was significantly linked with high diesel-traffic exhaust exposure.

Data Source: Data came from two independent studies, one with 104 asthma patients from the Cincinnati area, and a second comparing 20 patients with asthma with 17 control individuals from Brooklyn, N.Y.

Disclosures: Dr. Epstein and Dr. Vastardi said that they had no disclosures.

Food Allergic Infants More Likely to Have Vitamin D Insufficiency

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ORLANDO – Vitamin D insufficiency at age 1 year was associated with a nearly fourfold increased prevalence of a food allergy in a case-control study of 269 children.

The finding appears consistent with prior reports that linked the prevalence of food allergies to the latitude gradients for where people lived, Dr. Katrina J. Allen and her associates reported in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Those reports had suggested that the further people lived from the equator, the higher their rate of hospitalizations for food-allergy related events, said Dr. Allen, a pediatric allergist and gastroenterologist at Royal Children’s Hospital Melbourne, and her associates.

The study involved 5,276 12-month old infants from the Melbourne area enrolled in the Health Nuts population-based study. All infants had skin prick tests to egg white, peanut, and sesame; 1,005 developed at least a 1 mm wheal to at least one of these foods. Of the 834 food-sensitized infants who returned to the clinic for an oral food challenge with egg, peanut, and sesame, 351 were identified as food allergic with at least three non-contact hives or areas of urticaria that persisted for at least 5 minutes; perioral or periorbital angioedema; or severe and persistent vomiting or anaphylaxis (J. Allergy Clin. Immunol. 2012;129[suppl.]:AB141).

The researchers then drew blood specimens from 165 of the food-allergic infants and 104 control infants without food allergy or sensitivity, and measured their serum level of 25-hydroxyvitamin D.

In all, 92 of the control infants (88%) were vitamin D sufficient, with a serum level greater than 50 nM, corresponding to a level greater than 20 ng/mL. Among the infants with a food allergy, 118 (72%) were vitamin D sufficient (N. Engl. J. Med. 2011;364:248-54).

Vitamin D insufficiency, defined as a serum level of 26-50 nM (10 ng/mL to 20 ng/mL), occurred in 11% (11) of the control infants and in 25% (42) of the infants with a food allergy.

The remainder of the infants in the study, one in the control group and five in the food-allergy group, were vitamin D deficient, with a serum level of 25 nM or less (less than 10 ng/mL), but the numbers in this subgroup were too limited to allow a meaningful statistical analysis.

In a multiple logistical regression model that adjusted for diet (breast fed or formula fed), level of prior egg consumption, number of siblings, the presence of a pet dog, and ambient UV radiation exposure at the time of the blood draw, vitamin D insufficiency was linked with a statistically significant, 3.8-fold increased rate of food allergy, compared with the infants who were vitamin D sufficient, the researchers reported.

Dr. Allen and her associates said that they had no relevant financial disclosures.

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ORLANDO – Vitamin D insufficiency at age 1 year was associated with a nearly fourfold increased prevalence of a food allergy in a case-control study of 269 children.

The finding appears consistent with prior reports that linked the prevalence of food allergies to the latitude gradients for where people lived, Dr. Katrina J. Allen and her associates reported in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Those reports had suggested that the further people lived from the equator, the higher their rate of hospitalizations for food-allergy related events, said Dr. Allen, a pediatric allergist and gastroenterologist at Royal Children’s Hospital Melbourne, and her associates.

The study involved 5,276 12-month old infants from the Melbourne area enrolled in the Health Nuts population-based study. All infants had skin prick tests to egg white, peanut, and sesame; 1,005 developed at least a 1 mm wheal to at least one of these foods. Of the 834 food-sensitized infants who returned to the clinic for an oral food challenge with egg, peanut, and sesame, 351 were identified as food allergic with at least three non-contact hives or areas of urticaria that persisted for at least 5 minutes; perioral or periorbital angioedema; or severe and persistent vomiting or anaphylaxis (J. Allergy Clin. Immunol. 2012;129[suppl.]:AB141).

The researchers then drew blood specimens from 165 of the food-allergic infants and 104 control infants without food allergy or sensitivity, and measured their serum level of 25-hydroxyvitamin D.

In all, 92 of the control infants (88%) were vitamin D sufficient, with a serum level greater than 50 nM, corresponding to a level greater than 20 ng/mL. Among the infants with a food allergy, 118 (72%) were vitamin D sufficient (N. Engl. J. Med. 2011;364:248-54).

Vitamin D insufficiency, defined as a serum level of 26-50 nM (10 ng/mL to 20 ng/mL), occurred in 11% (11) of the control infants and in 25% (42) of the infants with a food allergy.

The remainder of the infants in the study, one in the control group and five in the food-allergy group, were vitamin D deficient, with a serum level of 25 nM or less (less than 10 ng/mL), but the numbers in this subgroup were too limited to allow a meaningful statistical analysis.

In a multiple logistical regression model that adjusted for diet (breast fed or formula fed), level of prior egg consumption, number of siblings, the presence of a pet dog, and ambient UV radiation exposure at the time of the blood draw, vitamin D insufficiency was linked with a statistically significant, 3.8-fold increased rate of food allergy, compared with the infants who were vitamin D sufficient, the researchers reported.

Dr. Allen and her associates said that they had no relevant financial disclosures.

ORLANDO – Vitamin D insufficiency at age 1 year was associated with a nearly fourfold increased prevalence of a food allergy in a case-control study of 269 children.

The finding appears consistent with prior reports that linked the prevalence of food allergies to the latitude gradients for where people lived, Dr. Katrina J. Allen and her associates reported in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Those reports had suggested that the further people lived from the equator, the higher their rate of hospitalizations for food-allergy related events, said Dr. Allen, a pediatric allergist and gastroenterologist at Royal Children’s Hospital Melbourne, and her associates.

The study involved 5,276 12-month old infants from the Melbourne area enrolled in the Health Nuts population-based study. All infants had skin prick tests to egg white, peanut, and sesame; 1,005 developed at least a 1 mm wheal to at least one of these foods. Of the 834 food-sensitized infants who returned to the clinic for an oral food challenge with egg, peanut, and sesame, 351 were identified as food allergic with at least three non-contact hives or areas of urticaria that persisted for at least 5 minutes; perioral or periorbital angioedema; or severe and persistent vomiting or anaphylaxis (J. Allergy Clin. Immunol. 2012;129[suppl.]:AB141).

The researchers then drew blood specimens from 165 of the food-allergic infants and 104 control infants without food allergy or sensitivity, and measured their serum level of 25-hydroxyvitamin D.

In all, 92 of the control infants (88%) were vitamin D sufficient, with a serum level greater than 50 nM, corresponding to a level greater than 20 ng/mL. Among the infants with a food allergy, 118 (72%) were vitamin D sufficient (N. Engl. J. Med. 2011;364:248-54).

Vitamin D insufficiency, defined as a serum level of 26-50 nM (10 ng/mL to 20 ng/mL), occurred in 11% (11) of the control infants and in 25% (42) of the infants with a food allergy.

The remainder of the infants in the study, one in the control group and five in the food-allergy group, were vitamin D deficient, with a serum level of 25 nM or less (less than 10 ng/mL), but the numbers in this subgroup were too limited to allow a meaningful statistical analysis.

In a multiple logistical regression model that adjusted for diet (breast fed or formula fed), level of prior egg consumption, number of siblings, the presence of a pet dog, and ambient UV radiation exposure at the time of the blood draw, vitamin D insufficiency was linked with a statistically significant, 3.8-fold increased rate of food allergy, compared with the infants who were vitamin D sufficient, the researchers reported.

Dr. Allen and her associates said that they had no relevant financial disclosures.

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Major Finding: Vitamin D–insufficient infants were 3.8-fold more likely to have a food allergy than controls.

Data Source: Findings were from an adjusted, case-control analysis of 165 12-month-old infants with a proven food allergy and 104 control infants with no food allergy or food sensitivity.

Disclosures: Dr. Allen and her associates said that they had no disclosures.

Multispecialty Team a Lifeline in Severe Asthma

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ORLANDO – A chart notation of "lost to follow-up" can mean loss of life for children with severe asthma, suggest the results of a retrospective study reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of 14 children who died from asthma at a children’s hospital over a 10-year period, 11 (79%) evidently never received follow-up care in the asthma clinic, despite having prior asthma-related hospitalizations and clinic appointments made at the time of discharge, reported Dr. Sahar Faghih, a second-year fellow in allergy and immunology at Children’s Hospital of Michigan in Detroit.

"Deaths of high-risk asthmatics were decreased by a combination of a multidisciplinary team clinic and a social service liaison for increased family support. This further emphasizes that barriers to care and clinic attendance necessitate further attention," Dr. Faghih and her colleagues wrote in a poster.

The investigators reviewed a decade of charts on children aged 1-18 years who died from asthma in the period spanning 3 years before to 7 years after the multidisciplinary Children’s Hospital Asthma Management Program (CHAMP) clinic opened in 2004. The social service component of the multidisciplinary team was phased out after 3 years due to lack of funding.

"Deaths of high-risk asthmatics were decreased by a combination of a multi-disciplinary team clinic and a social service liaison for increased family support."

Five of the 14 deaths occurred before the CHAMP clinic model was implemented, and none of these children were enrolled in a health plan. No deaths occurred during the 3 years that a social worker was present in the clinic.

"With the children who died in the care of the asthma clinic, there were some issues of adherence, and two out of five deaths that occurred between 2007 and 2010 occurred in patients who were previously enrolled in CHAMP. Both of those children had a history of medical neglect cases on file with the state," Dr. Faghih said in an interview.

"Perhaps if this clinic still had in place the social service intervention, we may have been able to prevent those deaths from happening," she added.

Although the multidisciplinary model was developed in a specialty children’s hospital, it can be replicated in community practices. Other studies have shown that programs coordinated by trained clinical nurses or nurse practitioners that include asthma education, emphasis on adherence, home visits, and telephone contacts can reduce asthma hospitalizations and emergency department visits by 71%-85%, Dr. Faghih said.

Team-based asthma education and case management programs can save money as well as lives, the investigators noted. They cited a randomized study showing that such programs reduced emergency department visits by 57%, hospitalizations by 75%, and expenditures by 71%. The same study estimated that for every dollar spent on a dedicated asthma nurse, $7.69-$11.76 was saved (J. Allergy Clin. Immunol. 1999;103:436-40).

"Based on 2008 CDC [Centers for Disease Control and Prevention] reporting, there have been a total of 200 pediatric asthma deaths. Perhaps, with the implementation of a multiteam approach, this number can be rectified," Dr. Faghih and her colleagues wrote.

The study was internally funded. The authors reported that they had no conflicts of interest.

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ORLANDO – A chart notation of "lost to follow-up" can mean loss of life for children with severe asthma, suggest the results of a retrospective study reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of 14 children who died from asthma at a children’s hospital over a 10-year period, 11 (79%) evidently never received follow-up care in the asthma clinic, despite having prior asthma-related hospitalizations and clinic appointments made at the time of discharge, reported Dr. Sahar Faghih, a second-year fellow in allergy and immunology at Children’s Hospital of Michigan in Detroit.

"Deaths of high-risk asthmatics were decreased by a combination of a multidisciplinary team clinic and a social service liaison for increased family support. This further emphasizes that barriers to care and clinic attendance necessitate further attention," Dr. Faghih and her colleagues wrote in a poster.

The investigators reviewed a decade of charts on children aged 1-18 years who died from asthma in the period spanning 3 years before to 7 years after the multidisciplinary Children’s Hospital Asthma Management Program (CHAMP) clinic opened in 2004. The social service component of the multidisciplinary team was phased out after 3 years due to lack of funding.

"Deaths of high-risk asthmatics were decreased by a combination of a multi-disciplinary team clinic and a social service liaison for increased family support."

Five of the 14 deaths occurred before the CHAMP clinic model was implemented, and none of these children were enrolled in a health plan. No deaths occurred during the 3 years that a social worker was present in the clinic.

"With the children who died in the care of the asthma clinic, there were some issues of adherence, and two out of five deaths that occurred between 2007 and 2010 occurred in patients who were previously enrolled in CHAMP. Both of those children had a history of medical neglect cases on file with the state," Dr. Faghih said in an interview.

"Perhaps if this clinic still had in place the social service intervention, we may have been able to prevent those deaths from happening," she added.

Although the multidisciplinary model was developed in a specialty children’s hospital, it can be replicated in community practices. Other studies have shown that programs coordinated by trained clinical nurses or nurse practitioners that include asthma education, emphasis on adherence, home visits, and telephone contacts can reduce asthma hospitalizations and emergency department visits by 71%-85%, Dr. Faghih said.

Team-based asthma education and case management programs can save money as well as lives, the investigators noted. They cited a randomized study showing that such programs reduced emergency department visits by 57%, hospitalizations by 75%, and expenditures by 71%. The same study estimated that for every dollar spent on a dedicated asthma nurse, $7.69-$11.76 was saved (J. Allergy Clin. Immunol. 1999;103:436-40).

"Based on 2008 CDC [Centers for Disease Control and Prevention] reporting, there have been a total of 200 pediatric asthma deaths. Perhaps, with the implementation of a multiteam approach, this number can be rectified," Dr. Faghih and her colleagues wrote.

The study was internally funded. The authors reported that they had no conflicts of interest.

ORLANDO – A chart notation of "lost to follow-up" can mean loss of life for children with severe asthma, suggest the results of a retrospective study reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Of 14 children who died from asthma at a children’s hospital over a 10-year period, 11 (79%) evidently never received follow-up care in the asthma clinic, despite having prior asthma-related hospitalizations and clinic appointments made at the time of discharge, reported Dr. Sahar Faghih, a second-year fellow in allergy and immunology at Children’s Hospital of Michigan in Detroit.

"Deaths of high-risk asthmatics were decreased by a combination of a multidisciplinary team clinic and a social service liaison for increased family support. This further emphasizes that barriers to care and clinic attendance necessitate further attention," Dr. Faghih and her colleagues wrote in a poster.

The investigators reviewed a decade of charts on children aged 1-18 years who died from asthma in the period spanning 3 years before to 7 years after the multidisciplinary Children’s Hospital Asthma Management Program (CHAMP) clinic opened in 2004. The social service component of the multidisciplinary team was phased out after 3 years due to lack of funding.

"Deaths of high-risk asthmatics were decreased by a combination of a multi-disciplinary team clinic and a social service liaison for increased family support."

Five of the 14 deaths occurred before the CHAMP clinic model was implemented, and none of these children were enrolled in a health plan. No deaths occurred during the 3 years that a social worker was present in the clinic.

"With the children who died in the care of the asthma clinic, there were some issues of adherence, and two out of five deaths that occurred between 2007 and 2010 occurred in patients who were previously enrolled in CHAMP. Both of those children had a history of medical neglect cases on file with the state," Dr. Faghih said in an interview.

"Perhaps if this clinic still had in place the social service intervention, we may have been able to prevent those deaths from happening," she added.

Although the multidisciplinary model was developed in a specialty children’s hospital, it can be replicated in community practices. Other studies have shown that programs coordinated by trained clinical nurses or nurse practitioners that include asthma education, emphasis on adherence, home visits, and telephone contacts can reduce asthma hospitalizations and emergency department visits by 71%-85%, Dr. Faghih said.

Team-based asthma education and case management programs can save money as well as lives, the investigators noted. They cited a randomized study showing that such programs reduced emergency department visits by 57%, hospitalizations by 75%, and expenditures by 71%. The same study estimated that for every dollar spent on a dedicated asthma nurse, $7.69-$11.76 was saved (J. Allergy Clin. Immunol. 1999;103:436-40).

"Based on 2008 CDC [Centers for Disease Control and Prevention] reporting, there have been a total of 200 pediatric asthma deaths. Perhaps, with the implementation of a multiteam approach, this number can be rectified," Dr. Faghih and her colleagues wrote.

The study was internally funded. The authors reported that they had no conflicts of interest.

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Major Finding: Of 14 children who died from asthma at a children's hospital over a 10-year period, 11 (79%) never received follow-up care in the asthma clinic, despite prior hospitalizations and scheduled follow-up appointments.

Data Source: The investigators reviewed a decade of charts on children aged 1-18

years who died from asthma in the period spanning 3 years before to 7

years after the multidisciplinary Children’s Hospital Asthma Management

Program (CHAMP) clinic opened in 2004.

Disclosures: The study was internally funded. The authors reported that they had no conflicts of interest.

Primary Care Offices Unprepared for Allergen Therapy Emergencies

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ORLANDO – A survey of primary care offices revealed that the majority were not fully equipped to handle adverse reactions to allergen immunotherapy.

"Primary care offices require further education on administration of allergen immunotherapy to ensure adherence to the updated practice parameter, as well as to ensure safety," Dr. Vinitha Reddy said at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

The telephone survey involved a questionnaire administered to nurses at 43 primary care offices (35 family medicine, 4 pediatric, and 4 internal medicine) that administer allergen immunotherapy (AIT). The practices employed a total 194 physicians, and administered AIT to approximately 500 patients.

The survey assessed adherence to the recommendations in "Allergen immunotherapy: a practice parameter third update," a joint guideline issued by the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology (J. Allergy Clin. Immunol. 2011;127:S1-55).

The guideline states that allergists’ offices are the preferred setting, but that primary care offices can perform AIT if the appropriate personnel and equipment are available to identify and treat anaphylaxis or other emergencies. The risk is low – approximately 0.2% of patients experience systemic reactions per injection, and deaths occur in just 1 per 2.5 million injections. However, the risk is not nonexistent, said Dr. Reddy, a second-year postgraduate fellow at Pennsylvania State University, Hershey.

Only 53% of the offices reported performing the recommended preinjection health assessment, which should include a determination of the presence of asthma and the degree of asthma control. Only 23% reported measuring peak flow, which is suggested as a method for assessing lung function in asthma patients.

Just 33% of the practices reported routinely having patients wait the recommended 30 minutes following AIT before leaving the office. Another 42% had patients wait just 20 minutes, and the other 25% had patients wait only 10 minutes.

Adverse reactions in the past 6 months, including hives, wheezing, or shortness of breath, were reported by 30% of the offices. None of the nurses reported having had a case of anaphylaxis, Dr. Reddy said.

All of the offices’ nurses said that they felt prepared to handle adverse reactions, and all said that they stock epinephrine, oxygen, and needles. The ability to administer antihistamines, corticosteroids, airway maintenance, and intravenous fluids was reported by 91%, 93%, 93%, and 70% of offices, respectively.

When offered in-service education on the AIT practice parameter, only 42% expressed interest. The other 58% stated that they did not have the time, Dr. Reddy reported.

During the question and answer period, an audience member commented that "it would be interesting" to conduct the same assessment in allergy practices, noting that "it may be about equal."

Dr. Reddy stated that she had no financial disclosures.

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ORLANDO – A survey of primary care offices revealed that the majority were not fully equipped to handle adverse reactions to allergen immunotherapy.

"Primary care offices require further education on administration of allergen immunotherapy to ensure adherence to the updated practice parameter, as well as to ensure safety," Dr. Vinitha Reddy said at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

The telephone survey involved a questionnaire administered to nurses at 43 primary care offices (35 family medicine, 4 pediatric, and 4 internal medicine) that administer allergen immunotherapy (AIT). The practices employed a total 194 physicians, and administered AIT to approximately 500 patients.

The survey assessed adherence to the recommendations in "Allergen immunotherapy: a practice parameter third update," a joint guideline issued by the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology (J. Allergy Clin. Immunol. 2011;127:S1-55).

The guideline states that allergists’ offices are the preferred setting, but that primary care offices can perform AIT if the appropriate personnel and equipment are available to identify and treat anaphylaxis or other emergencies. The risk is low – approximately 0.2% of patients experience systemic reactions per injection, and deaths occur in just 1 per 2.5 million injections. However, the risk is not nonexistent, said Dr. Reddy, a second-year postgraduate fellow at Pennsylvania State University, Hershey.

Only 53% of the offices reported performing the recommended preinjection health assessment, which should include a determination of the presence of asthma and the degree of asthma control. Only 23% reported measuring peak flow, which is suggested as a method for assessing lung function in asthma patients.

Just 33% of the practices reported routinely having patients wait the recommended 30 minutes following AIT before leaving the office. Another 42% had patients wait just 20 minutes, and the other 25% had patients wait only 10 minutes.

Adverse reactions in the past 6 months, including hives, wheezing, or shortness of breath, were reported by 30% of the offices. None of the nurses reported having had a case of anaphylaxis, Dr. Reddy said.

All of the offices’ nurses said that they felt prepared to handle adverse reactions, and all said that they stock epinephrine, oxygen, and needles. The ability to administer antihistamines, corticosteroids, airway maintenance, and intravenous fluids was reported by 91%, 93%, 93%, and 70% of offices, respectively.

When offered in-service education on the AIT practice parameter, only 42% expressed interest. The other 58% stated that they did not have the time, Dr. Reddy reported.

During the question and answer period, an audience member commented that "it would be interesting" to conduct the same assessment in allergy practices, noting that "it may be about equal."

Dr. Reddy stated that she had no financial disclosures.

ORLANDO – A survey of primary care offices revealed that the majority were not fully equipped to handle adverse reactions to allergen immunotherapy.

"Primary care offices require further education on administration of allergen immunotherapy to ensure adherence to the updated practice parameter, as well as to ensure safety," Dr. Vinitha Reddy said at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

The telephone survey involved a questionnaire administered to nurses at 43 primary care offices (35 family medicine, 4 pediatric, and 4 internal medicine) that administer allergen immunotherapy (AIT). The practices employed a total 194 physicians, and administered AIT to approximately 500 patients.

The survey assessed adherence to the recommendations in "Allergen immunotherapy: a practice parameter third update," a joint guideline issued by the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology (J. Allergy Clin. Immunol. 2011;127:S1-55).

The guideline states that allergists’ offices are the preferred setting, but that primary care offices can perform AIT if the appropriate personnel and equipment are available to identify and treat anaphylaxis or other emergencies. The risk is low – approximately 0.2% of patients experience systemic reactions per injection, and deaths occur in just 1 per 2.5 million injections. However, the risk is not nonexistent, said Dr. Reddy, a second-year postgraduate fellow at Pennsylvania State University, Hershey.

Only 53% of the offices reported performing the recommended preinjection health assessment, which should include a determination of the presence of asthma and the degree of asthma control. Only 23% reported measuring peak flow, which is suggested as a method for assessing lung function in asthma patients.

Just 33% of the practices reported routinely having patients wait the recommended 30 minutes following AIT before leaving the office. Another 42% had patients wait just 20 minutes, and the other 25% had patients wait only 10 minutes.

Adverse reactions in the past 6 months, including hives, wheezing, or shortness of breath, were reported by 30% of the offices. None of the nurses reported having had a case of anaphylaxis, Dr. Reddy said.

All of the offices’ nurses said that they felt prepared to handle adverse reactions, and all said that they stock epinephrine, oxygen, and needles. The ability to administer antihistamines, corticosteroids, airway maintenance, and intravenous fluids was reported by 91%, 93%, 93%, and 70% of offices, respectively.

When offered in-service education on the AIT practice parameter, only 42% expressed interest. The other 58% stated that they did not have the time, Dr. Reddy reported.

During the question and answer period, an audience member commented that "it would be interesting" to conduct the same assessment in allergy practices, noting that "it may be about equal."

Dr. Reddy stated that she had no financial disclosures.

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Desensitization Succeeds for Aspirin-Allergic Heart Patients

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ORLANDO – Coronary disease patients with a history of aspirin sensitivity who need to start a daily aspirin regimen can safely and quickly undergo desensitization, often as outpatients, that gets them on the drug, according to two case series reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The trickiest cases are patients with aspirin-exacerbated respiratory disease (AERD), but both of these programs have steered a handful of AERD patients through desensitization safely and effectively.

"Our cardiologists love that we do this for them," Dr. John A. Saryan said while presenting a poster at the meeting. "They started to ask us 6 years ago; they said they really needed aspirin for patients receiving drug-eluting coronary stents. We tried to talk the cardiologists out of it, but then decided to try it and we had no trouble. By now we’ve done 20, 25 patients," said Dr. Saryan, chairman of allergy and immunology at the Lahey Clinic in Burlington, Mass. He presented details from the first 14 patients he and his associates desensitized. "Ten years ago I would have said it’s nuts, I wouldn’t do it," but his recent experience changed his mind, he said in an interview.

Dr. H. James Wedner

"The patients do very well, with no problems; we have no worries about these patients, but the AERD patients are very different. We do them in a spirometry laboratory, and we get a FEV1 [forced expiratory volume in one second] before each desensitization dose," said Dr. H. James Wedner, professor of medicine and chief of the division of allergy and immunology at Washington University, St. Louis. He presented a poster on 23 coronary disease patients he treated for aspirin desensitization since 1996, but added that he has treated additional patients who required aspirin for treatment of arthritis.

Dr. Wedner’s usual protocol involves no prophylactic anti-allergy treatment. Patients identified as having true aspirin sensitivity by their history start on a supervised protocol of aspirin ingestion using a 10-mg/mL solution made by dissolving an Alka-Seltzer tablet in water. Patients start by drinking a 1-mg dose, waiting 15 minutes, and then taking a 10-mg dose, followed by doses of 20 mg, 40 mg, 80 mg, 160 mg, and 325 mg, each delivered 15 minutes apart. Patients who develop a rash as they progress through the doses receive an antihistamine, such as diphenhydramine (Benedryl) or cetirizine (Zyrtec). Three of the 23 patients in the series developed angioedema, two of them safely continued with the protocol. The third patient decided to withdraw from further desensitization, the only patient in the series who did not complete the process, Dr. Wedner reported.

Once patients do this, they can then safely take an aspirin a day. If they miss a dose for more than 48 hours they have to be desensitized again. In Dr. Wedner's series, 3 of the 23 patients needed a second desensitization course. Ten of the courses occurred on an inpatient basis, the other 16 on an outpatient basis.

Patients with a history of AERD go through the same desensitization steps, but with FEV1 monitoring. If their FEV1 drops by 20% or more at any point the protocol stops and the patient goes home but then comes back and continues the protocol the next day, and "they do better," Dr. Wedner said. Although AERD patients have reactions, they can safely proceed through full desensitization, he said. "Some patients drop their FEV1 twice, and it takes 3 days, but ultimately they all get through."

A key preliminary step is taking a careful history to identify patients with true aspirin sensitivity, he added. "There is no skin test or blood test for aspirin sensitivity. It’s all based on history." About 50% of patients Dr. Wedner sees with suspected aspirin sensitivity had been misidentified and don’t need desensitization.

The protocol Dr. Saryan and his associates at Lahey use involves systematic pretreatment with antihistamines, leukotriene-modifying drugs such as montelukast (Singulair) or zileuton (Zyflo), and in one case, prednisone. Many patients received prophylactic drugs from more than one class. The Lahey physicians gear the aggressiveness of the prophylaxis to each patient’s history: the severity of their past aspirin reactions, and their current medical state. "If a coronary patient is unstable, you don’t want them to have a reaction, as respiratory effects can lead to changes in heart rate" or have other cardiac consequences, noted Dr. David E. Riester, an allergist and immunologist at Lahey who also managed these cases.

They modeled their outpatient desensitization protocol on the method reported in 2000 by physicians at Massachusetts General Hospital in Boston (J. Allergy Clin. Immunol. 2000;105:997-1001). The Lahey group has its pharmacy prepare an aspirin solution that gets dosed to a patient starting with 0.1 mg, and then progressing through doses of 0.3 mg, 1 mg, 3 mg, 10 mg, 20 mg, 40 mg, 81 mg, 162 mg, and finishing with 243 or 325 mg. They separate each dose by 20-30 minutes.

 

 

For patients with a history of AERD, they do the desensitization in their CCU or ICU, and space out each incremental dose in the sequence by 2-3 hours, doing the protocol over 2 days. They modeled this approach on a 2003 report by Dr. Donald D. Stevenson of the Scripps Clinic, La Jolla, Calif. (Clin. Rev. Allergy Immunol. 2003;24:159-67).

None of the 14 coronary disease patients in the series from Lahey included patients with AERD. All 14 patients underwent successful desensitization, with 3 having a reaction during the process, in one case a respiratory reaction.

Dr. Saryan, Dr. Wedner, and Dr. Riester said that they had no disclosures.

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ORLANDO – Coronary disease patients with a history of aspirin sensitivity who need to start a daily aspirin regimen can safely and quickly undergo desensitization, often as outpatients, that gets them on the drug, according to two case series reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The trickiest cases are patients with aspirin-exacerbated respiratory disease (AERD), but both of these programs have steered a handful of AERD patients through desensitization safely and effectively.

"Our cardiologists love that we do this for them," Dr. John A. Saryan said while presenting a poster at the meeting. "They started to ask us 6 years ago; they said they really needed aspirin for patients receiving drug-eluting coronary stents. We tried to talk the cardiologists out of it, but then decided to try it and we had no trouble. By now we’ve done 20, 25 patients," said Dr. Saryan, chairman of allergy and immunology at the Lahey Clinic in Burlington, Mass. He presented details from the first 14 patients he and his associates desensitized. "Ten years ago I would have said it’s nuts, I wouldn’t do it," but his recent experience changed his mind, he said in an interview.

Dr. H. James Wedner

"The patients do very well, with no problems; we have no worries about these patients, but the AERD patients are very different. We do them in a spirometry laboratory, and we get a FEV1 [forced expiratory volume in one second] before each desensitization dose," said Dr. H. James Wedner, professor of medicine and chief of the division of allergy and immunology at Washington University, St. Louis. He presented a poster on 23 coronary disease patients he treated for aspirin desensitization since 1996, but added that he has treated additional patients who required aspirin for treatment of arthritis.

Dr. Wedner’s usual protocol involves no prophylactic anti-allergy treatment. Patients identified as having true aspirin sensitivity by their history start on a supervised protocol of aspirin ingestion using a 10-mg/mL solution made by dissolving an Alka-Seltzer tablet in water. Patients start by drinking a 1-mg dose, waiting 15 minutes, and then taking a 10-mg dose, followed by doses of 20 mg, 40 mg, 80 mg, 160 mg, and 325 mg, each delivered 15 minutes apart. Patients who develop a rash as they progress through the doses receive an antihistamine, such as diphenhydramine (Benedryl) or cetirizine (Zyrtec). Three of the 23 patients in the series developed angioedema, two of them safely continued with the protocol. The third patient decided to withdraw from further desensitization, the only patient in the series who did not complete the process, Dr. Wedner reported.

Once patients do this, they can then safely take an aspirin a day. If they miss a dose for more than 48 hours they have to be desensitized again. In Dr. Wedner's series, 3 of the 23 patients needed a second desensitization course. Ten of the courses occurred on an inpatient basis, the other 16 on an outpatient basis.

Patients with a history of AERD go through the same desensitization steps, but with FEV1 monitoring. If their FEV1 drops by 20% or more at any point the protocol stops and the patient goes home but then comes back and continues the protocol the next day, and "they do better," Dr. Wedner said. Although AERD patients have reactions, they can safely proceed through full desensitization, he said. "Some patients drop their FEV1 twice, and it takes 3 days, but ultimately they all get through."

A key preliminary step is taking a careful history to identify patients with true aspirin sensitivity, he added. "There is no skin test or blood test for aspirin sensitivity. It’s all based on history." About 50% of patients Dr. Wedner sees with suspected aspirin sensitivity had been misidentified and don’t need desensitization.

The protocol Dr. Saryan and his associates at Lahey use involves systematic pretreatment with antihistamines, leukotriene-modifying drugs such as montelukast (Singulair) or zileuton (Zyflo), and in one case, prednisone. Many patients received prophylactic drugs from more than one class. The Lahey physicians gear the aggressiveness of the prophylaxis to each patient’s history: the severity of their past aspirin reactions, and their current medical state. "If a coronary patient is unstable, you don’t want them to have a reaction, as respiratory effects can lead to changes in heart rate" or have other cardiac consequences, noted Dr. David E. Riester, an allergist and immunologist at Lahey who also managed these cases.

They modeled their outpatient desensitization protocol on the method reported in 2000 by physicians at Massachusetts General Hospital in Boston (J. Allergy Clin. Immunol. 2000;105:997-1001). The Lahey group has its pharmacy prepare an aspirin solution that gets dosed to a patient starting with 0.1 mg, and then progressing through doses of 0.3 mg, 1 mg, 3 mg, 10 mg, 20 mg, 40 mg, 81 mg, 162 mg, and finishing with 243 or 325 mg. They separate each dose by 20-30 minutes.

 

 

For patients with a history of AERD, they do the desensitization in their CCU or ICU, and space out each incremental dose in the sequence by 2-3 hours, doing the protocol over 2 days. They modeled this approach on a 2003 report by Dr. Donald D. Stevenson of the Scripps Clinic, La Jolla, Calif. (Clin. Rev. Allergy Immunol. 2003;24:159-67).

None of the 14 coronary disease patients in the series from Lahey included patients with AERD. All 14 patients underwent successful desensitization, with 3 having a reaction during the process, in one case a respiratory reaction.

Dr. Saryan, Dr. Wedner, and Dr. Riester said that they had no disclosures.

ORLANDO – Coronary disease patients with a history of aspirin sensitivity who need to start a daily aspirin regimen can safely and quickly undergo desensitization, often as outpatients, that gets them on the drug, according to two case series reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The trickiest cases are patients with aspirin-exacerbated respiratory disease (AERD), but both of these programs have steered a handful of AERD patients through desensitization safely and effectively.

"Our cardiologists love that we do this for them," Dr. John A. Saryan said while presenting a poster at the meeting. "They started to ask us 6 years ago; they said they really needed aspirin for patients receiving drug-eluting coronary stents. We tried to talk the cardiologists out of it, but then decided to try it and we had no trouble. By now we’ve done 20, 25 patients," said Dr. Saryan, chairman of allergy and immunology at the Lahey Clinic in Burlington, Mass. He presented details from the first 14 patients he and his associates desensitized. "Ten years ago I would have said it’s nuts, I wouldn’t do it," but his recent experience changed his mind, he said in an interview.

Dr. H. James Wedner

"The patients do very well, with no problems; we have no worries about these patients, but the AERD patients are very different. We do them in a spirometry laboratory, and we get a FEV1 [forced expiratory volume in one second] before each desensitization dose," said Dr. H. James Wedner, professor of medicine and chief of the division of allergy and immunology at Washington University, St. Louis. He presented a poster on 23 coronary disease patients he treated for aspirin desensitization since 1996, but added that he has treated additional patients who required aspirin for treatment of arthritis.

Dr. Wedner’s usual protocol involves no prophylactic anti-allergy treatment. Patients identified as having true aspirin sensitivity by their history start on a supervised protocol of aspirin ingestion using a 10-mg/mL solution made by dissolving an Alka-Seltzer tablet in water. Patients start by drinking a 1-mg dose, waiting 15 minutes, and then taking a 10-mg dose, followed by doses of 20 mg, 40 mg, 80 mg, 160 mg, and 325 mg, each delivered 15 minutes apart. Patients who develop a rash as they progress through the doses receive an antihistamine, such as diphenhydramine (Benedryl) or cetirizine (Zyrtec). Three of the 23 patients in the series developed angioedema, two of them safely continued with the protocol. The third patient decided to withdraw from further desensitization, the only patient in the series who did not complete the process, Dr. Wedner reported.

Once patients do this, they can then safely take an aspirin a day. If they miss a dose for more than 48 hours they have to be desensitized again. In Dr. Wedner's series, 3 of the 23 patients needed a second desensitization course. Ten of the courses occurred on an inpatient basis, the other 16 on an outpatient basis.

Patients with a history of AERD go through the same desensitization steps, but with FEV1 monitoring. If their FEV1 drops by 20% or more at any point the protocol stops and the patient goes home but then comes back and continues the protocol the next day, and "they do better," Dr. Wedner said. Although AERD patients have reactions, they can safely proceed through full desensitization, he said. "Some patients drop their FEV1 twice, and it takes 3 days, but ultimately they all get through."

A key preliminary step is taking a careful history to identify patients with true aspirin sensitivity, he added. "There is no skin test or blood test for aspirin sensitivity. It’s all based on history." About 50% of patients Dr. Wedner sees with suspected aspirin sensitivity had been misidentified and don’t need desensitization.

The protocol Dr. Saryan and his associates at Lahey use involves systematic pretreatment with antihistamines, leukotriene-modifying drugs such as montelukast (Singulair) or zileuton (Zyflo), and in one case, prednisone. Many patients received prophylactic drugs from more than one class. The Lahey physicians gear the aggressiveness of the prophylaxis to each patient’s history: the severity of their past aspirin reactions, and their current medical state. "If a coronary patient is unstable, you don’t want them to have a reaction, as respiratory effects can lead to changes in heart rate" or have other cardiac consequences, noted Dr. David E. Riester, an allergist and immunologist at Lahey who also managed these cases.

They modeled their outpatient desensitization protocol on the method reported in 2000 by physicians at Massachusetts General Hospital in Boston (J. Allergy Clin. Immunol. 2000;105:997-1001). The Lahey group has its pharmacy prepare an aspirin solution that gets dosed to a patient starting with 0.1 mg, and then progressing through doses of 0.3 mg, 1 mg, 3 mg, 10 mg, 20 mg, 40 mg, 81 mg, 162 mg, and finishing with 243 or 325 mg. They separate each dose by 20-30 minutes.

 

 

For patients with a history of AERD, they do the desensitization in their CCU or ICU, and space out each incremental dose in the sequence by 2-3 hours, doing the protocol over 2 days. They modeled this approach on a 2003 report by Dr. Donald D. Stevenson of the Scripps Clinic, La Jolla, Calif. (Clin. Rev. Allergy Immunol. 2003;24:159-67).

None of the 14 coronary disease patients in the series from Lahey included patients with AERD. All 14 patients underwent successful desensitization, with 3 having a reaction during the process, in one case a respiratory reaction.

Dr. Saryan, Dr. Wedner, and Dr. Riester said that they had no disclosures.

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Major Finding: Coronary disease patients who required aspirin treatment but had a history of aspirin sensitivity safely and successfully underwent desensitization.

Data Source: Data are from two single-center, U.S. cases series, one with 23 coronary disease patients, the second with 14 coronary patients.

Disclosures: Dr. Saryan, Dr. Wedner, and Dr. Riester said that they had no disclosures.

Asthma Meds: Men Prefer to Inhale, Women to Take Pills

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ORLANDO – Men may be more adherent than women are in their use of asthma controller medications, but adherence overall is poor, according to an analysis of claims from a large database.

Older adults were also more adherent than were younger adults in the retrospective cohort study, which included medical and pharmacy claims for 145,950 patients aged 18-65 years who were seen from January 2006 to December 2008.

To be included, patients included had to have 12 months or more of continuous medical and pharmacy eligibility following the index date (6 months after first medical claim for asthma), said Leslie J. Hinyard, Ph.D. at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Mean age at enrollment was 41 years for the 53,532 men, and 43 years for the 92,418 women. Adherence was defined by the Medication Possession Ratio (MPR), calculated as the number of days for which the medication is supplied divided by the number of days from first fill through the end of study eligibility.

Overall adherence, stratified by gender, ranged from a low MPR of 0.246 for inhaled corticosteroid use among women to a high of 0.597 for omalizumab use in women.

"I was actually surprised by how poor adherence was across the board. It’s actually consistent with what you find throughout the literature; but the adherence to what should be medicines taken daily over a long period of time is rather poor," said Dr. Hinyard, who is with the St. Louis University Center for Outcomes Research and also the university’s department of internal medicine, division of allergy.

Men had significantly greater adherence than did women for inhaled corticosteroid (MPR, 0.259 vs. 0.246), long-acting beta-agonists (0.384 vs. 0.345), combinations of the two (0.388 vs. 0.352), and for mast cell–stabilizing agents (0.238 vs. 0.205). On the other hand, women were significantly more adherent than men were for leukotriene modifiers (0.499 vs. 0.472).

"I was intrigued by the fact that, across the board, men seemed to have slightly higher adherence than women, except for leukotriene modifiers, which are pills. The rest are all inhaled," Dr. Hinyard said in an interview.

She noted that the explanation could be that women are more accustomed than are men to taking pills, rather than that men are more apt to use inhalers. However, she emphasized, "I’m completely speculating."

There was no statistically significant difference between men and women for oral steroid use, monoclonal antibodies, or theophylline.

Examined by age tertiles of 18-34 years, 35-49 years, and 50-65 years, there was a positive linear association between age and adherence for all drug categories except for chronic oral steroids.

For example, with inhaled corticosteroids, 45% of those aged 50-65 years fell into the top tertile for adherence, compared with 16% of the 18- to 34-year-olds. "Older adults were more adherent, especially compared to the younger adults," she noted.

"We need to understand if there’s a minimal threshold for adherence that will keep people from having exacerbations," Dr. Hinyard said. "We’re never going to get perfect adherence, but perhaps we can set a more realistic goal for people to strive for."

Dr. Hinyard had no relevant disclosures.

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ORLANDO – Men may be more adherent than women are in their use of asthma controller medications, but adherence overall is poor, according to an analysis of claims from a large database.

Older adults were also more adherent than were younger adults in the retrospective cohort study, which included medical and pharmacy claims for 145,950 patients aged 18-65 years who were seen from January 2006 to December 2008.

To be included, patients included had to have 12 months or more of continuous medical and pharmacy eligibility following the index date (6 months after first medical claim for asthma), said Leslie J. Hinyard, Ph.D. at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Mean age at enrollment was 41 years for the 53,532 men, and 43 years for the 92,418 women. Adherence was defined by the Medication Possession Ratio (MPR), calculated as the number of days for which the medication is supplied divided by the number of days from first fill through the end of study eligibility.

Overall adherence, stratified by gender, ranged from a low MPR of 0.246 for inhaled corticosteroid use among women to a high of 0.597 for omalizumab use in women.

"I was actually surprised by how poor adherence was across the board. It’s actually consistent with what you find throughout the literature; but the adherence to what should be medicines taken daily over a long period of time is rather poor," said Dr. Hinyard, who is with the St. Louis University Center for Outcomes Research and also the university’s department of internal medicine, division of allergy.

Men had significantly greater adherence than did women for inhaled corticosteroid (MPR, 0.259 vs. 0.246), long-acting beta-agonists (0.384 vs. 0.345), combinations of the two (0.388 vs. 0.352), and for mast cell–stabilizing agents (0.238 vs. 0.205). On the other hand, women were significantly more adherent than men were for leukotriene modifiers (0.499 vs. 0.472).

"I was intrigued by the fact that, across the board, men seemed to have slightly higher adherence than women, except for leukotriene modifiers, which are pills. The rest are all inhaled," Dr. Hinyard said in an interview.

She noted that the explanation could be that women are more accustomed than are men to taking pills, rather than that men are more apt to use inhalers. However, she emphasized, "I’m completely speculating."

There was no statistically significant difference between men and women for oral steroid use, monoclonal antibodies, or theophylline.

Examined by age tertiles of 18-34 years, 35-49 years, and 50-65 years, there was a positive linear association between age and adherence for all drug categories except for chronic oral steroids.

For example, with inhaled corticosteroids, 45% of those aged 50-65 years fell into the top tertile for adherence, compared with 16% of the 18- to 34-year-olds. "Older adults were more adherent, especially compared to the younger adults," she noted.

"We need to understand if there’s a minimal threshold for adherence that will keep people from having exacerbations," Dr. Hinyard said. "We’re never going to get perfect adherence, but perhaps we can set a more realistic goal for people to strive for."

Dr. Hinyard had no relevant disclosures.

ORLANDO – Men may be more adherent than women are in their use of asthma controller medications, but adherence overall is poor, according to an analysis of claims from a large database.

Older adults were also more adherent than were younger adults in the retrospective cohort study, which included medical and pharmacy claims for 145,950 patients aged 18-65 years who were seen from January 2006 to December 2008.

To be included, patients included had to have 12 months or more of continuous medical and pharmacy eligibility following the index date (6 months after first medical claim for asthma), said Leslie J. Hinyard, Ph.D. at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Mean age at enrollment was 41 years for the 53,532 men, and 43 years for the 92,418 women. Adherence was defined by the Medication Possession Ratio (MPR), calculated as the number of days for which the medication is supplied divided by the number of days from first fill through the end of study eligibility.

Overall adherence, stratified by gender, ranged from a low MPR of 0.246 for inhaled corticosteroid use among women to a high of 0.597 for omalizumab use in women.

"I was actually surprised by how poor adherence was across the board. It’s actually consistent with what you find throughout the literature; but the adherence to what should be medicines taken daily over a long period of time is rather poor," said Dr. Hinyard, who is with the St. Louis University Center for Outcomes Research and also the university’s department of internal medicine, division of allergy.

Men had significantly greater adherence than did women for inhaled corticosteroid (MPR, 0.259 vs. 0.246), long-acting beta-agonists (0.384 vs. 0.345), combinations of the two (0.388 vs. 0.352), and for mast cell–stabilizing agents (0.238 vs. 0.205). On the other hand, women were significantly more adherent than men were for leukotriene modifiers (0.499 vs. 0.472).

"I was intrigued by the fact that, across the board, men seemed to have slightly higher adherence than women, except for leukotriene modifiers, which are pills. The rest are all inhaled," Dr. Hinyard said in an interview.

She noted that the explanation could be that women are more accustomed than are men to taking pills, rather than that men are more apt to use inhalers. However, she emphasized, "I’m completely speculating."

There was no statistically significant difference between men and women for oral steroid use, monoclonal antibodies, or theophylline.

Examined by age tertiles of 18-34 years, 35-49 years, and 50-65 years, there was a positive linear association between age and adherence for all drug categories except for chronic oral steroids.

For example, with inhaled corticosteroids, 45% of those aged 50-65 years fell into the top tertile for adherence, compared with 16% of the 18- to 34-year-olds. "Older adults were more adherent, especially compared to the younger adults," she noted.

"We need to understand if there’s a minimal threshold for adherence that will keep people from having exacerbations," Dr. Hinyard said. "We’re never going to get perfect adherence, but perhaps we can set a more realistic goal for people to strive for."

Dr. Hinyard had no relevant disclosures.

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Asthma Guidelines Are Not Always Followed

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ORLANDO – The 2007 National Asthma Education and Prevention Program guidelines are viewed as cumbersome and too time-consuming by some primary care physicians caring for children.

That finding, from a 23-question survey sent to 80 pediatricians, suggests that "there is room for improvement. I think the allergist can play a big role in helping co-manage severe asthmatic patients," Dr. Nabeel Farooqui of Ohio State University and Nationwide Children’s Hospital, Columbus, Ohio, said in an interview at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The Expert Panel Report 3 (EPR3): Guidelines for the Diagnosis and Management of Asthma, published by the National Heart, Lung, and Blood Institute, recommend referral to an asthma subspecialist for patients with difficult-to-manage moderate to severe persistent asthma, when a diagnosis is in question, or for patients who need additional testing. Such a subspecialist could be either an allergist or a pulmonologist, but only the allergist can do an allergy assessment, Dr. Farooqui noted.

"Many children with asthma also have allergic rhinitis. These children should be skin-tested. Allergists can help diagnose and treat some of the allergic comorbidities associated with asthma such as allergic rhinitis, and thereby get better control of the asthma," he said.

Of the 28 pediatricians who responded to the anonymous survey, 13 (46%) said that they "always" follow the NAEPP EPR 3 guidelines. Another 8 (29%) said they follow the guidelines "most of the time." Among those who didn’t always follow the guidelines, the most common reason, given by 11 respondents (39% of the total), was that they are "too cumbersome."

Nearly two-thirds of the respondents (17) reported always initiating inhaled steroids for patients with persistent asthma, whereas the other 11 expressed at least some hesitation. "Concern about nonadherence" to inhaled steroids was listed most often as the reason.

Just 15 of the 28 respondents (54%) reported reviewing a written asthma action plan with their patients at every visit as recommended, whereas another 12 (43%) did so only when they made a change in the patient’s care. Lack of time was listed by eight respondents as the reason not to review the plan at every visit, while another six said they did not think that such plans improve management or outcomes.

While all of the respondents endorsed influenza immunization for all asthma patients, nine mistakenly believed that egg allergy is a contraindication to receipt of the vaccine. (The contraindication was lifted in June 2011.)

While all but one respondent said that they refer difficult-to-manage asthma patients to subspecialists, only half referred for additional testing and less than half for a questionable diagnosis. The majority (69%) refer to pulmonologists, while the other 31% referred patients to both a pulmonologist and an allergist/immunologist. "The only time referral to allergist is made is when the patient is sent to pulmonary as well," Dr. Farooqui commented.

"Lack of timely appointment" was the most common reason given for not referring to a subspecialist.

For patients with well-controlled asthma who are on a daily controller medication, half of the respondents endorsed the recommended evaluation at 3-6 months for consideration of step-down therapy. However, the other half reported waiting a year or never stepping down therapy.

"Allergists should continue to promote their role, both in the community and academic centers, as specialists in the evaluation and management of asthma," Dr. Farooqui advised his colleagues.

Dr. Farooqui said he had no relevant financial disclosures.

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ORLANDO – The 2007 National Asthma Education and Prevention Program guidelines are viewed as cumbersome and too time-consuming by some primary care physicians caring for children.

That finding, from a 23-question survey sent to 80 pediatricians, suggests that "there is room for improvement. I think the allergist can play a big role in helping co-manage severe asthmatic patients," Dr. Nabeel Farooqui of Ohio State University and Nationwide Children’s Hospital, Columbus, Ohio, said in an interview at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The Expert Panel Report 3 (EPR3): Guidelines for the Diagnosis and Management of Asthma, published by the National Heart, Lung, and Blood Institute, recommend referral to an asthma subspecialist for patients with difficult-to-manage moderate to severe persistent asthma, when a diagnosis is in question, or for patients who need additional testing. Such a subspecialist could be either an allergist or a pulmonologist, but only the allergist can do an allergy assessment, Dr. Farooqui noted.

"Many children with asthma also have allergic rhinitis. These children should be skin-tested. Allergists can help diagnose and treat some of the allergic comorbidities associated with asthma such as allergic rhinitis, and thereby get better control of the asthma," he said.

Of the 28 pediatricians who responded to the anonymous survey, 13 (46%) said that they "always" follow the NAEPP EPR 3 guidelines. Another 8 (29%) said they follow the guidelines "most of the time." Among those who didn’t always follow the guidelines, the most common reason, given by 11 respondents (39% of the total), was that they are "too cumbersome."

Nearly two-thirds of the respondents (17) reported always initiating inhaled steroids for patients with persistent asthma, whereas the other 11 expressed at least some hesitation. "Concern about nonadherence" to inhaled steroids was listed most often as the reason.

Just 15 of the 28 respondents (54%) reported reviewing a written asthma action plan with their patients at every visit as recommended, whereas another 12 (43%) did so only when they made a change in the patient’s care. Lack of time was listed by eight respondents as the reason not to review the plan at every visit, while another six said they did not think that such plans improve management or outcomes.

While all of the respondents endorsed influenza immunization for all asthma patients, nine mistakenly believed that egg allergy is a contraindication to receipt of the vaccine. (The contraindication was lifted in June 2011.)

While all but one respondent said that they refer difficult-to-manage asthma patients to subspecialists, only half referred for additional testing and less than half for a questionable diagnosis. The majority (69%) refer to pulmonologists, while the other 31% referred patients to both a pulmonologist and an allergist/immunologist. "The only time referral to allergist is made is when the patient is sent to pulmonary as well," Dr. Farooqui commented.

"Lack of timely appointment" was the most common reason given for not referring to a subspecialist.

For patients with well-controlled asthma who are on a daily controller medication, half of the respondents endorsed the recommended evaluation at 3-6 months for consideration of step-down therapy. However, the other half reported waiting a year or never stepping down therapy.

"Allergists should continue to promote their role, both in the community and academic centers, as specialists in the evaluation and management of asthma," Dr. Farooqui advised his colleagues.

Dr. Farooqui said he had no relevant financial disclosures.

ORLANDO – The 2007 National Asthma Education and Prevention Program guidelines are viewed as cumbersome and too time-consuming by some primary care physicians caring for children.

That finding, from a 23-question survey sent to 80 pediatricians, suggests that "there is room for improvement. I think the allergist can play a big role in helping co-manage severe asthmatic patients," Dr. Nabeel Farooqui of Ohio State University and Nationwide Children’s Hospital, Columbus, Ohio, said in an interview at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The Expert Panel Report 3 (EPR3): Guidelines for the Diagnosis and Management of Asthma, published by the National Heart, Lung, and Blood Institute, recommend referral to an asthma subspecialist for patients with difficult-to-manage moderate to severe persistent asthma, when a diagnosis is in question, or for patients who need additional testing. Such a subspecialist could be either an allergist or a pulmonologist, but only the allergist can do an allergy assessment, Dr. Farooqui noted.

"Many children with asthma also have allergic rhinitis. These children should be skin-tested. Allergists can help diagnose and treat some of the allergic comorbidities associated with asthma such as allergic rhinitis, and thereby get better control of the asthma," he said.

Of the 28 pediatricians who responded to the anonymous survey, 13 (46%) said that they "always" follow the NAEPP EPR 3 guidelines. Another 8 (29%) said they follow the guidelines "most of the time." Among those who didn’t always follow the guidelines, the most common reason, given by 11 respondents (39% of the total), was that they are "too cumbersome."

Nearly two-thirds of the respondents (17) reported always initiating inhaled steroids for patients with persistent asthma, whereas the other 11 expressed at least some hesitation. "Concern about nonadherence" to inhaled steroids was listed most often as the reason.

Just 15 of the 28 respondents (54%) reported reviewing a written asthma action plan with their patients at every visit as recommended, whereas another 12 (43%) did so only when they made a change in the patient’s care. Lack of time was listed by eight respondents as the reason not to review the plan at every visit, while another six said they did not think that such plans improve management or outcomes.

While all of the respondents endorsed influenza immunization for all asthma patients, nine mistakenly believed that egg allergy is a contraindication to receipt of the vaccine. (The contraindication was lifted in June 2011.)

While all but one respondent said that they refer difficult-to-manage asthma patients to subspecialists, only half referred for additional testing and less than half for a questionable diagnosis. The majority (69%) refer to pulmonologists, while the other 31% referred patients to both a pulmonologist and an allergist/immunologist. "The only time referral to allergist is made is when the patient is sent to pulmonary as well," Dr. Farooqui commented.

"Lack of timely appointment" was the most common reason given for not referring to a subspecialist.

For patients with well-controlled asthma who are on a daily controller medication, half of the respondents endorsed the recommended evaluation at 3-6 months for consideration of step-down therapy. However, the other half reported waiting a year or never stepping down therapy.

"Allergists should continue to promote their role, both in the community and academic centers, as specialists in the evaluation and management of asthma," Dr. Farooqui advised his colleagues.

Dr. Farooqui said he had no relevant financial disclosures.

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Major Finding: Forty-six percent of pediatricians responded that they "always" follow the NAEPP EPR 3 guidelines. Another 29% said they follow the guidelines "most of the time." Among those who didn’t always follow the guidelines, the most common reason, given by 11 respondents (39% of the total), was that they are "too cumbersome."

Data Source: These were results of a 23-question survey sent to 80 pediatricians, of whom 28 responded.

Disclosures: Dr. Farooqui said he had no relevant financial disclosures.