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AIRTIVITY Study

Phase 3 Clinical Trial

About This Study

The AIRTIVITY Study is a Phase 3 randomized, placebo-controlled study evaluating BI 1291583 in people with bronchiectasis. Participants take either BI 1291583 or placebo once daily. The study includes site visits, phone calls, and smartphone symptom tracking to assess flare-ups, safety, and overall health.

Eligibility Criteria

Inclusion Criteria

  • Confirmed bronchiectasis on CT
  • Able to produce sputum during screening
  • History of flare-ups/exacerbations requiring antibiotic treatment in the last 12 months
  • Signed informed consent

Exclusion Criteria

  • Tuberculosis or nontuberculous mycobacterial infection being treated or requiring treatment
  • Acute respiratory infection or ongoing pulmonary exacerbation at screening unless recovered before randomization
  • Allergic bronchopulmonary aspergillosis being treated or requiring treatment
  • Prior treatment with a DPP1 / CatC inhibitor
  • Other significant medical or laboratory findings that, in the investigator's opinion, make participation unsafe