Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD QVA149 NVA237 indacaterol combination bronchodilator
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 160
Healthy volunteers: no

Brief summary:
This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 (\[glycopyrronium bromide\]) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms:
arm 1: QVA149 110/50 μg once a day (o.d) arm 2: tiotropium 18 μg o.d.

Interventions: intervention 1: QVA149 intervention 2: Tiotropium
Intervention descriptions: intervention 1: QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1 intervention 2: Tiotropium (18 μg o.d.), delivered via Handihaler®

Protocol document: