A randomised, double-blind, parallel group, roll-over study evaluating long-term safety and efficacy of oral doses of BI 1291583 q.d. in patients with bronchiectasis (ClairleafTM)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503290-38-00

Acronym

1397-0017

Enrollment

114

Registered

2023-08-29

Start date

2023-09-05

Completion date

Unknown

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Brief summary

Occurrence of treatment-emergent AEs (TEAEs) over the course of this trial

Detailed description

Time to first pulmonary exacerbation from first drug administration in this trial to the end of the trial, Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial

Interventions

DRUGPlacebo matching to BI 1291583 5 mg

DRUGBI 1291583 5 mg

DRUGBI 1291583 1 mg

DRUGPlacebo matching to BI 1291583 1 mg

DRUGBI 1291583 2.5 mg

DRUGPlacebo matching to BI 1291583 2.5 mg

DRUGSALBUTAMOL SULFATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of treatment-emergent AEs (TEAEs) over the course of this trial	—

Secondary

Measure	Time frame
Time to first pulmonary exacerbation from first drug administration in this trial to the end of the trial, Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial	—

Countries

Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026