cystic fibrosis bronchiectasis
Conditions
Brief summary
Occurrence of TEAEs up to 16 weeks from first drug administration.
Detailed description
Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 8 after first drug administration (8 weeks was chosen as timepoint for this secondary endpoint to synchronise with potential cycling antibiotic use), AUC over a dosing interval (AUCτ) for the first dose., Maximum concentration (Cmax) for the first dose., AUCτ at steady state (AUCτ,ss)., Cmax at steady state (Cmax,ss).
Interventions
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of TEAEs up to 16 weeks from first drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 8 after first drug administration (8 weeks was chosen as timepoint for this secondary endpoint to synchronise with potential cycling antibiotic use), AUC over a dosing interval (AUCτ) for the first dose., Maximum concentration (Cmax) for the first dose., AUCτ at steady state (AUCτ,ss)., Cmax at steady state (Cmax,ss). | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed