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COMPLETED Phase 2

A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)

NCT05865886 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 22 participants
Start Date 2024-04-05
Est. Completion 2024-10-07
Phase Phase 2

Sponsor

Boehringer Ingelheim

203 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05865886 reports 12 study locations spanning 3 distinct geographic areas — top geographies include Other, Kansas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05865886?

The interventions under investigation include: BI 1291583 (DRUG), Placebo to BI 1291583 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05865886?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial