A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
Phase 2
Completed
NCT05865886
| Condition | Cystic Fibrosis, Bronchiectasis |
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| Phase | Phase 2 |
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| Sponsor | Boehringer Ingelheim |
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| Status | Completed |
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| Enrollment | 22 participants |
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| Interventions | BI 1291583, Placebo to BI 1291583 |
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| Start date | Apr 5, 2024 |
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| Completion date | Oct 7, 2024 |
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| Results posted | Nov 18, 2025 |
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Summary
This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis. The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants are put randomly into 2 groups. One group takes BI 1291583 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1291583 tablets but do not contain any medicine. Participants in both groups take 1 tablet once a day for 12 weeks. Participants have twice the chance of being placed in the BI 1291583 group than in the placebo group. Participants are in the study for about 6 months. During this time, they visit the study site 7 times. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1291583.
Occurrence of Any Treatment Emergent Adverse Events
From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks. · Percentage of participants
| Placebo | 85.7 Percentage of participants |
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| BI 1291583 5 mg | 93.3 Percentage of participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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