Non-cystic Fibrosis Bronchiectasis
Conditions
Brief summary
TTF (Time to first) Exacerbation
Detailed description
Annualized Exacerbation Rate (AER) (Exacerbation Event Rate Per Participant-year of Follow-up), Number of Participants Achieving a Clinically Important Difference in the Quality of Life–Bronchiectasis (QoL-B) Respiratory Symptoms Scale, Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale, Change From Baseline in QoL-B Respiratory Symptoms Scale, Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria isolated from Sputum, Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs), Percentage of Participants with TEAEs and SAEs
Interventions
DRUGPlacebo
DRUGinhalation solution
Sponsors
CSL Behring LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTF (Time to first) Exacerbation | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized Exacerbation Rate (AER) (Exacerbation Event Rate Per Participant-year of Follow-up), Number of Participants Achieving a Clinically Important Difference in the Quality of Life–Bronchiectasis (QoL-B) Respiratory Symptoms Scale, Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale, Change From Baseline in QoL-B Respiratory Symptoms Scale, Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria isolated from Sputum, Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs), Percentage of Participants with TEAEs and SAEs | — |
Countries
Belgium, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Spain
Outcome results
None listed