BI 1291583
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim
Conditions
BronchiectasisCystic FibrosisHealthyHepatic Impairment
Phase 1
This Study Tests How Different Doses of BI 1291583 Are Taken up in the Body and How Well They Are Tolerated
TerminatedNCT03414008
Start: 2018-02-05End: 2019-11-18Updated: 2025-08-13
A Study to Test How Food Influences the Amount of BI 1291583 in the Blood of Healthy Men
CompletedNCT03837964
Start: 2019-02-27End: 2019-04-24Updated: 2025-08-13
A Study in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated
TerminatedNCT03868540
Start: 2019-03-28End: 2019-11-25Updated: 2025-08-13
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1291583 in the Blood
CompletedNCT03890887
Start: 2019-04-12End: 2019-07-29Updated: 2025-08-13
A Trial in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated
CompletedNCT04866160
Start: 2021-05-17End: 2021-11-30Updated: 2025-08-13
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated
CompletedNCT05183347
Start: 2022-02-04End: 2022-07-27Updated: 2025-08-13
A Study in Healthy Men to Test How BI 1291583 is Taken up by the Body
CompletedNCT06166992
Start: 2023-12-12End: 2024-02-07Updated: 2025-08-13
A Study in Healthy People to Test How 2 Different Doses of BI 1291583 Are Taken up in the Body When Given in 3 Different Formulations
CompletedNCT06631417
Start: 2024-10-22End: 2025-05-14Updated: 2025-08-13
A Study in Healthy People to Test Whether BI 1291583 Influences the Amount of Dabigatran in the Body
CompletedNCT06791187
Start: 2025-01-23End: 2025-03-27Updated: 2025-08-13
A Study in Healthy People to Test Whether Erythromycin Influences the Amount of BI 1291583 in the Blood
CompletedNCT06917872
Start: 2025-04-29End: 2025-09-09Updated: 2025-09-16
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
RecruitingNCT07023354
Start: 2025-07-17End: 2026-12-23Target: 32Updated: 2026-09-04
Phase 2
A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
CompletedNCT05238675
Start: 2022-04-28End: 2024-05-30Updated: 2026-07-28
Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine
Active, not recruitingNCT05846230
Start: 2023-09-08End: 2027-03-31Updated: 2026-08-21
A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
CompletedNCT05865886
Start: 2024-04-05End: 2024-10-07Updated: 2026-06-23
Phase 3
The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
RecruitingNCT06872892
Start: 2025-06-09End: 2027-12-20Target: 1755Updated: 2026-09-18
A Phase III, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of BI 1291583 2.5 mg administered once daily for up to 76 weeks in patients with bronchiectasis (The AIRTIVITY TM Study)
RecruitingCTIS2024-518589-29-00
Start: 2025-08-21Target: 519Updated: 2026-01-27