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: clintriage.rdg@boehringer-ingelheim.com
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: rhasson@pacificlinkconsulting.com
Study start date: July 2022
Expected completion Date: November 2022