Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Age≥40 yrs, Glycopyrronium Bromide
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 83
Healthy volunteers: no

Brief summary:
This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients with stable COPD, in comparison to an active comparator.

Detailed description:

Arms:
arm 1: 12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 2: 25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 3: 50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 4: 100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 5: Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 6: 18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.

Interventions: intervention 1: NVA237 intervention 2: Placebo intervention 3: Tiotropium
Intervention descriptions: intervention 1: single-dose dry-powder inhaler (SDDPI) intervention 2: single-dose dry-powder inhaler (SDDPI) intervention 3: Handihaler inhaler

Protocol document: