Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QVA149, FLAME( EFfect of Indacaterol Glycopyronium Vs Fluticasone salmeterol on COPD Exacerbations)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3362
Healthy volunteers: no

Brief summary:
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

Detailed description:

Arms:
arm 1: QVA149 (110/50 μg) once daily arm 2: Salmeterol/fluticasone (50/500μg) b.i.d

Interventions: intervention 1: QVA149 intervention 2: Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Intervention descriptions: intervention 1: QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI. intervention 2: Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.

Protocol document: