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A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis

NCT05238675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2025-08-14

No results posted yet for this study

Summary

This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of 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 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day.

Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff.

The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

Interventions

DRUG

BI 1291583

BI 1291583

DRUG

Placebo

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2024-05-01
Completion
2024-05-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Latvia
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05238675 on ClinicalTrials.gov