Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD NVA237
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 211
Healthy volunteers: no

Brief summary:
This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .

Detailed description:

Arms:
arm 1: 50µg once daily arm 2: 18µg once daily

Interventions: intervention 1: NVA237 intervention 2: Tiotropium
Intervention descriptions: intervention 1: 50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®) intervention 2: 18µg capsules for inhalation, delivered via HandiHaler®

Protocol document: