Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 388
Healthy volunteers: no

Brief summary:
This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.

Detailed description:

Arms:
arm 1: NVA237 12.5 µg once daily arm 2: NVA237 25.0 µg once daily arm 3: NVA237 12.5 µg twice daily arm 4: NVA237 50.0 µg once daily arm 5: NVA237 25.0 µg twice daily arm 6: NVA237 100.0 µg once daily arm 7: NVA237 50.0 µg twice daily arm 8: Placebo to NVA237 once daily

Interventions: intervention 1: NVA237 12.5 µg once daily intervention 2: NVA237 25.0 µg once daily intervention 3: NVA237 12.5 µg twice daily intervention 4: NVA237 50.0 µg once daily intervention 5: NVA237 25.0 µg twice daily intervention 6: NVA237 100.0 µg once daily intervention 7: NVA237 50.0 µg twice daily intervention 8: Placebo to NVA237 once daily
Intervention descriptions: intervention 1: NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. intervention 2: NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. intervention 3: NVA237 12.5 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2. intervention 4: NVA237 50.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. intervention 5: NVA237 25.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2. intervention 6: NVA237 100.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. intervention 7: NVA237 50.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2. intervention 8: Placebo to NVA237 via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

Protocol document: