Asthma
Conditions
Brief summary
Change from Baseline in trough FEV1 at week 2 of each treatment period
Detailed description
Steady state pharmacokinetic (PK) concentration profiles and parameters for each glycopyrronium dose level as feasible, Change from Baseline (morning and evening) in PEF rate averaged over 2 weeks of each treatment period, Change from Baseline in FEV1 at 30 min and 1 hour post dose at week 2 of each treatment period, Change from baseline in rescue medication use over 2 weeks of each treatment period 1. Adverse events (AEs), electrocardiograms (ECGs), vital signs 2. Laboratory parameters including blood glucose and serum potassium levels, Adverse events of special interest (AESI) typical of anti-muscarinic side effects (including dry mouth, fatigue, constipation, and urinary retention)
Interventions
DRUGThe Placebo is a generic Placebo
DRUGinhalation powder
DRUGhard capsule. It is used to match an active dosage forms (NVA237 12.5µg and NVA 237 25µg) in this clinical trial. The placebo comprises inactive excipients (magnesium stearate and lactose monohydrate) encapsulated in hard non-gelatin capsules matching those used for the active drug product.
DRUGNVA237
DRUGSALBUTAMOL
DRUGFLUTICASONE PROPIONATE
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in trough FEV1 at week 2 of each treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Steady state pharmacokinetic (PK) concentration profiles and parameters for each glycopyrronium dose level as feasible, Change from Baseline (morning and evening) in PEF rate averaged over 2 weeks of each treatment period, Change from Baseline in FEV1 at 30 min and 1 hour post dose at week 2 of each treatment period, Change from baseline in rescue medication use over 2 weeks of each treatment period 1. Adverse events (AEs), electrocardiograms (ECGs), vital signs 2. Laboratory parameters including blood glucose and serum potassium levels, Adverse events of special interest (AESI) typical of anti-muscarinic side effects (including dry mouth, fatigue, constipation, and urinary retention) | — |
Countries
Bulgaria, Hungary, Poland, Spain
Outcome results
None listed