Clinical Trial

The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.
Protocol Amendment History 5 changes
notable Primary completion moved earlier: 2028-09-14 -> 2027-06-15 2026-08-07
minor Completion moved earlier: 2028-10-12 -> 2027-12-20 2026-08-07
notable Trial sites reduced: 488 -> 470 locations 2026-07-29
notable Trial sites reduced: 494 -> 488 locations 2026-07-10
notable Trial sites reduced: 498 -> 495 locations 2026-04-16
Trial Details
NCT Number NCT06872892
Lead Sponsor Boehringer Ingelheim
Conditions Bronchiectasis
Enrollment 1,755 participants
Start Date 2025-06-09
Primary Completion 2027-06-15 (estimated)
Study Completion 2027-12-20 (estimated)
Updated on ClinicalTrials.gov 2026-08-06