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NCT05865886 · ClinicalTrials.gov registry record · Phase 2
A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
A Phase 2 study of Cystic Fibrosis and Bronchiectasis, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 12
- Study locations
NCT05865886 is a Phase 2 study of Cystic Fibrosis and Bronchiectasis that has completed, run by Boehringer Ingelheim. The registered enrollment target is 22 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (88% lower). The trial reports 12 study locations across 3 states.
The verdict
NCT05865886, a Phase 2 study of Cystic Fibrosis and Bronchiectasis, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 12
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG BI 1291583
- DRUG Placebo to BI 1291583
Study Locations (12)
Other
- UZ Leuven - Leuven
- Charite Universitätsmedizin Berlin KöR - Berlin
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Essen
- Medizinische Hochschule Hannover - Hanover
- Universitätsklinikum Jena - Jena
- Azienda Ospedaliera Meyer - Florence
- Azienda Ospedaliera Universitaria Integrata Verona - Verona
- Amsterdam UMC, location VUMC - Amsterdam
- Universitair Medisch Centrum Utrecht - Utrecht
- Hospital Universitari Vall D Hebron - Barcelona
Kansas
- University of Kansas Medical Center - Kansas City
New York
- Northwell Health Physician Partners - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-04-05 |
| Est. Completion | 2024-10-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05865886
The ClinicalTrials.gov registry entry for NCT05865886 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (88% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which BI 1291583 is the first listed.
NCT05865886 reports 12 study locations spanning 3 distinct geographic areas - top geographies include Other, Kansas, New York.
Frequently Asked Questions
What is clinical trial NCT05865886 about?
NCT05865886 is a clinical study titled "A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)". 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...
What is the current status of trial NCT05865886?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2024-04-05. Estimated completion is 2024-10-07.
What conditions does trial NCT05865886 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Bronchiectasis.
What interventions are being tested in trial NCT05865886?
The interventions under investigation include: BI 1291583 (DRUG), Placebo to BI 1291583 (DRUG).
Who is sponsoring clinical trial NCT05865886?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05865886 being conducted?
This trial has 12 study locations across Kansas, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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