A Phase 3 interventional study of verducatib in Bronchiectasis, sponsored by Boehringer Ingelheim. Not yet recruiting at 383 sites in 39 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
This study is for adults and adolescents who are at least 12 years old and have bronchiectasis. People can participate if they completed a previous study with the study medicine called verducatib. The purpose of this study is to find out how well verducatib is tolerated when people with bronchiectasis take it for a long time. The study also looks at breathing problems, how often lung flare-ups happen, and how quickly lung function changes.
This is a roll-over study for participants who completed a previous study with verducatib: AIRTIVITY® (1397-0014) or CLAIRLEAF® (1397-0017). All participants receive verducatib. Participants take verducatib as tablets once a day at home. They may continue their usual treatment for bronchiectasis during the study.
Participants can stay in the study for up to 1 year and 9 months. Treatment with verducatib can continue for up to 1 year and 6 months. About 6 study visits are done at the study site and about 4 are done by phone. At all visits, the doctors check participants' health and collect information on any health problems that occur during the study. The doctors also look at lung flare-ups and measure lung function over time.
377 studies on the registry are indexed under Bronchiectasis; 105 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 60 across 241 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Boehringer Ingelheim is the lead sponsor of 2,300 studies on the registry; 59 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion criteria:
Further exclusion criteria apply.
Participants with bronchiectasis who completed parent trials AIRTIVITY® (1397-0014) or CLAIRLEAF® (1397-0017) and did not prematurely discontinue the trial drug.
Drug: verducatib
verducatib
Also known as: BI 1291583
Occurrence of treatment-emergent adverse events (TEAEs) over the course of this trial
Time frame: up to 78 weeks
Annualised rate of pulmonary exacerbations (number of events per person-time) up to Week 78
Time frame: up to 78 weeks
Time to first pulmonary exacerbation from first drug administration up to Week 78
Time frame: up to 78 weeks
Absolute change from baseline in post-bronchodilator forced expiratory volume in the first second (FEV1) %pred up to Week 78
Time frame: at baseline, at week 78
Absolute change from baseline in post-bronchodilator forced vital capacity (FVC) %pred up to Week 78
Time frame: at baseline, at week 78
High-resolution computed tomography (HRCT) substudy: Change from baseline (52-week HRCT from the parent trial) in total number of mucus plugs at Week 78
Time frame: at baseline, at week 78
HRCT substudy: Change from baseline (52-week HRCT from the parent trial) in volume of mucus plugs at Week 78
Time frame: at baseline, at week 78
HRCT substudy: Change from baseline (52-week HRCT from the parent trial) in bronchial wall area over bronchial outer area (Bwa/Boa) at Week 78
Time frame: at baseline, at week 78
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Showing the first 100 of 383 sites across 39 countries. Choose a country and city above to see the rest.
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 on the website.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com
Start is estimated for Jan 2027; primary completion for Jul 2029, 30 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Verducatib