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This column presents a sampling of new and still-recruiting trials of interest to pulmonologists and their patients.
Trials are selected based primarily on these conditions: idiopathic pulmonary fibrosis/interstitial lung disease; chronic obstructive pulmonary disease (COPD); asthma; cystic fibrosis; infectious lung diseases; pulmonary artery hypertension; and lung cancer. Links to the studies and contact information are provided for each.
Idiopathic pulmonary fibrosis/interstitial lung disease
A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD™-ON): NCT05285982
This nonrandomized, phase 3 study is open to children and adolescents between 6 and 17 years old who have interstitial lung disease with lung fibrosis. It is designed to test how well long-term treatment with nintedanib (a drug already used to treat lung fibrosis in adults) is tolerated in children and adolescents.
A total of 60 study participants will take nintedanib capsules twice a day for at least 2 years or until nintedanib or other treatment options become available outside of the study. There will be 9-11 site visits during the first 2 years and site visits every 3 months afterward.
Study physicians will collect information on any health problems of the participants. The primary outcome measure will be the incidence of treatment-emergent adverse events.
Location: 26 locations in the United States and internationally
Sponsor: Boehringer Ingelheim
Contact: [email protected]
Study start date: April 2022
Expected completion Date: May 2026
Asthma
A Phase 2, Single-Dose, Randomized, Active and Placebo Controlled, Four-Period, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma: NCT05363670
ARS-1 is a novel aqueous formulation of epinephrine nasal spray. The primary outcomes of this study will be the effect of ARS-1 versus albuterol and placebo from baseline to 1 hour on the difference in forced expiratory volume in 1 second based on area under the curve.
A total of 30 study participants (ages 12-65 years) will be recruited.
Location: Three U.S. locations in Florida, Maryland, and Ohio.
Sponsor: ARS Pharmaceuticals
Contact: [email protected]
Study start date: July 2022
Expected completion Date: November 2022
COPD
Treatment of Pneumocystitis in COPD (the TOPIC Study): NCT05418777
In this randomized, double-blind, placebo-controlled study, the primary outcome will be to determine if treating Pneumocystis jirovecii in acute exacerbations of COPD with confirmed P. jirovecii colonization has a beneficial clinical impact. As a secondary goal of the study, it will be determined if the addition of trimethoprim-sulfamethoxazole (TMP-SMX) to standard of care can decolonize these patients and if the decolonization is durable for at least 3 months.
A total of 30 participants aged 40-89 years will be randomized to receive either a suspension with the equivalent of one double-strength TMP-SMX or a suspension with placebo by mouth every 12 hours. If the participant is discharged prior to completing the 10-day course of the medication, they will be sent home with the remaining study medication and a medication diary which will be collected.
Location: William Beaumont Hospital, Royal Oak, Mich.
Sponsor: William Beaumont Hospitals
Contact: [email protected]
Study start date: July 2022
Expected completion Date: August 2023
Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction (SAVED-1): NCT05257681
This study is intended to be a pilot prospective controlled clinical trial to evaluate the potential role of a lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction via the use of endobronchial valves therapy.
In 20 select patients (ages 40-75 years), the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal. The primary outcomes will be to prove that interlobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction over a 2 year period and the occurrence of adverse events in that period. The surgery will be considered feasible if the target inter-lobar fissure can be completed in at least 90% of the patients enrolled. Secondary outcomes over 2 years will include quality of life improvement and the percentage of patients with significant changes in pulmonary function testing.
Location: Beth Deaconess Medical Center, Boston
Sponsor: Beth Israel Deaconess Medical Center
Contact: [email protected]
Study start date: May 2022
Expected completion Date: May 2024
This column presents a sampling of new and still-recruiting trials of interest to pulmonologists and their patients.
Trials are selected based primarily on these conditions: idiopathic pulmonary fibrosis/interstitial lung disease; chronic obstructive pulmonary disease (COPD); asthma; cystic fibrosis; infectious lung diseases; pulmonary artery hypertension; and lung cancer. Links to the studies and contact information are provided for each.
Idiopathic pulmonary fibrosis/interstitial lung disease
A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD™-ON): NCT05285982
This nonrandomized, phase 3 study is open to children and adolescents between 6 and 17 years old who have interstitial lung disease with lung fibrosis. It is designed to test how well long-term treatment with nintedanib (a drug already used to treat lung fibrosis in adults) is tolerated in children and adolescents.
A total of 60 study participants will take nintedanib capsules twice a day for at least 2 years or until nintedanib or other treatment options become available outside of the study. There will be 9-11 site visits during the first 2 years and site visits every 3 months afterward.
Study physicians will collect information on any health problems of the participants. The primary outcome measure will be the incidence of treatment-emergent adverse events.
Location: 26 locations in the United States and internationally
Sponsor: Boehringer Ingelheim
Contact: [email protected]
Study start date: April 2022
Expected completion Date: May 2026
Asthma
A Phase 2, Single-Dose, Randomized, Active and Placebo Controlled, Four-Period, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma: NCT05363670
ARS-1 is a novel aqueous formulation of epinephrine nasal spray. The primary outcomes of this study will be the effect of ARS-1 versus albuterol and placebo from baseline to 1 hour on the difference in forced expiratory volume in 1 second based on area under the curve.
A total of 30 study participants (ages 12-65 years) will be recruited.
Location: Three U.S. locations in Florida, Maryland, and Ohio.
Sponsor: ARS Pharmaceuticals
Contact: [email protected]
Study start date: July 2022
Expected completion Date: November 2022
COPD
Treatment of Pneumocystitis in COPD (the TOPIC Study): NCT05418777
In this randomized, double-blind, placebo-controlled study, the primary outcome will be to determine if treating Pneumocystis jirovecii in acute exacerbations of COPD with confirmed P. jirovecii colonization has a beneficial clinical impact. As a secondary goal of the study, it will be determined if the addition of trimethoprim-sulfamethoxazole (TMP-SMX) to standard of care can decolonize these patients and if the decolonization is durable for at least 3 months.
A total of 30 participants aged 40-89 years will be randomized to receive either a suspension with the equivalent of one double-strength TMP-SMX or a suspension with placebo by mouth every 12 hours. If the participant is discharged prior to completing the 10-day course of the medication, they will be sent home with the remaining study medication and a medication diary which will be collected.
Location: William Beaumont Hospital, Royal Oak, Mich.
Sponsor: William Beaumont Hospitals
Contact: [email protected]
Study start date: July 2022
Expected completion Date: August 2023
Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction (SAVED-1): NCT05257681
This study is intended to be a pilot prospective controlled clinical trial to evaluate the potential role of a lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction via the use of endobronchial valves therapy.
In 20 select patients (ages 40-75 years), the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal. The primary outcomes will be to prove that interlobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction over a 2 year period and the occurrence of adverse events in that period. The surgery will be considered feasible if the target inter-lobar fissure can be completed in at least 90% of the patients enrolled. Secondary outcomes over 2 years will include quality of life improvement and the percentage of patients with significant changes in pulmonary function testing.
Location: Beth Deaconess Medical Center, Boston
Sponsor: Beth Israel Deaconess Medical Center
Contact: [email protected]
Study start date: May 2022
Expected completion Date: May 2024
This column presents a sampling of new and still-recruiting trials of interest to pulmonologists and their patients.
Trials are selected based primarily on these conditions: idiopathic pulmonary fibrosis/interstitial lung disease; chronic obstructive pulmonary disease (COPD); asthma; cystic fibrosis; infectious lung diseases; pulmonary artery hypertension; and lung cancer. Links to the studies and contact information are provided for each.
Idiopathic pulmonary fibrosis/interstitial lung disease
A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD™-ON): NCT05285982
This nonrandomized, phase 3 study is open to children and adolescents between 6 and 17 years old who have interstitial lung disease with lung fibrosis. It is designed to test how well long-term treatment with nintedanib (a drug already used to treat lung fibrosis in adults) is tolerated in children and adolescents.
A total of 60 study participants will take nintedanib capsules twice a day for at least 2 years or until nintedanib or other treatment options become available outside of the study. There will be 9-11 site visits during the first 2 years and site visits every 3 months afterward.
Study physicians will collect information on any health problems of the participants. The primary outcome measure will be the incidence of treatment-emergent adverse events.
Location: 26 locations in the United States and internationally
Sponsor: Boehringer Ingelheim
Contact: [email protected]
Study start date: April 2022
Expected completion Date: May 2026
Asthma
A Phase 2, Single-Dose, Randomized, Active and Placebo Controlled, Four-Period, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma: NCT05363670
ARS-1 is a novel aqueous formulation of epinephrine nasal spray. The primary outcomes of this study will be the effect of ARS-1 versus albuterol and placebo from baseline to 1 hour on the difference in forced expiratory volume in 1 second based on area under the curve.
A total of 30 study participants (ages 12-65 years) will be recruited.
Location: Three U.S. locations in Florida, Maryland, and Ohio.
Sponsor: ARS Pharmaceuticals
Contact: [email protected]
Study start date: July 2022
Expected completion Date: November 2022
COPD
Treatment of Pneumocystitis in COPD (the TOPIC Study): NCT05418777
In this randomized, double-blind, placebo-controlled study, the primary outcome will be to determine if treating Pneumocystis jirovecii in acute exacerbations of COPD with confirmed P. jirovecii colonization has a beneficial clinical impact. As a secondary goal of the study, it will be determined if the addition of trimethoprim-sulfamethoxazole (TMP-SMX) to standard of care can decolonize these patients and if the decolonization is durable for at least 3 months.
A total of 30 participants aged 40-89 years will be randomized to receive either a suspension with the equivalent of one double-strength TMP-SMX or a suspension with placebo by mouth every 12 hours. If the participant is discharged prior to completing the 10-day course of the medication, they will be sent home with the remaining study medication and a medication diary which will be collected.
Location: William Beaumont Hospital, Royal Oak, Mich.
Sponsor: William Beaumont Hospitals
Contact: [email protected]
Study start date: July 2022
Expected completion Date: August 2023
Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction (SAVED-1): NCT05257681
This study is intended to be a pilot prospective controlled clinical trial to evaluate the potential role of a lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction via the use of endobronchial valves therapy.
In 20 select patients (ages 40-75 years), the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal. The primary outcomes will be to prove that interlobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction over a 2 year period and the occurrence of adverse events in that period. The surgery will be considered feasible if the target inter-lobar fissure can be completed in at least 90% of the patients enrolled. Secondary outcomes over 2 years will include quality of life improvement and the percentage of patients with significant changes in pulmonary function testing.
Location: Beth Deaconess Medical Center, Boston
Sponsor: Beth Israel Deaconess Medical Center
Contact: [email protected]
Study start date: May 2022
Expected completion Date: May 2024