Bronchiectasis
Conditions
Brief summary
Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76.
Detailed 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
Interventions
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden
Outcome results
None listed