Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: chronic obstructive pulmonary disease COPD QVA149 QAB149 NVA237 Indacaterol maleate Glycopyronnium bromide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1215
Healthy volunteers: no

Brief summary:
The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: QVA149 intervention 2: Tiotropium intervention 3: placebo
Intervention descriptions: intervention 1: QVA149 110/50 µg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI intervention 2: Tiotropium 18 µg will be supplied as capsules in blister packs for once daily inhalation using the HandiHaler SDDPI intervention 3: placebo to QVA149A and Tiotropium will be supplied in the appropriate capsule in blister packs for use in either the Novartis Concept1 SDDPI or the HandiHaler SDDPI

Protocol document: