A Phase III, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of BI 1291583 2.5 mg administered once daily for up to 76 weeks in patients with bronchiectasis (The AIRTIVITY TM Study)
Phase 3 – large-scale trial before approval
Conditions:
Bronchiectasis
Sponsor: Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
trial.available_in:
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Overview
Trial status: Authorised
Absolute change from baseline in post-bronchodilator FEV1 %pred at Week 52, Absolute change from baseline in QOL-B respiratory symptoms domain score at Week 52 (participants ≥16 years), Time to first adjudicated pulmonary exacerbation up to Week 76, Absolute change from baseline in post-bronchodilator FVC %pred at Week 52, Annualised rate of severe adjudicated pulmonary exacerbations up to Week 76, Time to first severe adjudicated pulmonary exacerbation up to Week 76
Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76.
Description
Absolute change from baseline in post-bronchodilator FEV1 %pred at Week 52, Absolute change from baseline in QOL-B respiratory symptoms domain score at Week 52 (participants ≥16 years), Time to first adjudicated pulmonary exacerbation up to Week 76, Absolute change from baseline in post-bronchodilator FVC %pred at Week 52, Annualised rate of severe adjudicated pulmonary exacerbations up to Week 76, Time to first severe adjudicated pulmonary exacerbation up to Week 76
Who can participate
Age group: 0-17 years, 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 534 participants
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