A Phase 2 interventional study of BI 1291583 and Placebo matching BI 1291583 in Bronchiectasis, sponsored by Boehringer Ingelheim. Active, not recruiting at 102 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
This study is open to adults aged 18 years and older with bronchiectasis. People can join the study if they were previously enrolled in another study with BI 1291583 (1397-0012: Airleafᵀᴹ or 1397-0013 Clairaflyᵀᴹ). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis, an inflammatory lung condition. The investigators also want to know how well people with this condition can tolerate BI 1291583 in the long term.
Participants take a low, medium, or high dose of BI 1291583 as a tablet once a day for up to 1 year. Participants who were taking placebo in the AirleafTM or ClairaflyTM study are put into the BI 1291583 dosage groups randomly, which means by chance. Placebo tablets look like BI1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the AirleafTM or ClairaflyTM study continue to take the same dose.
Participants visit the study site 10 times and get 4 phone calls from the site staff. During the visits, the doctors collect information on any health problems of the participants. The doctors also check whether BI 1291583 helps reduce the symptoms of bronchiectasis.
368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.
This study's enrollment of 268 is above the median of 60 across 233 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laboratory and medical examination
New concomitant diagnosis and therapy
A new diagnosis of
Drug: BI 1291583 · Drug: Placebo matching BI 1291583
Drug: BI 1291583 · Drug: Placebo matching BI 1291583
Drug: BI 1291583 · Drug: Placebo matching BI 1291583
Tablet
Also known as: Verducatib
Tablet
Occurrence of treatment-emergent adverse events (TEAEs)
Time frame: up to 12 months
Time to first pulmonary exacerbation from first drug administration in this trial to the end of the trial
A pulmonary exacerbation in this trial is defined as having three or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics (oral or intravenous): * Increased cough * Increased sputum volume or change in sputum consistency * Increased sputum purulence * Increased breathlessness and/or decreased exercise tolerance * Fatigue and/or malaise * Hemoptysis
Time frame: up to 12 months
Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial
Time frame: up to 12 months
Showing the first 100 of 102 sites across 22 countries.
Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim