Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 355
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.

Detailed description:

Arms:
arm 1: QVA149 capsules for inhalation, delivered via QVA149 SDDPI arm 2: Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Interventions: intervention 1: QVA149 intervention 2: Umeclidinium/vilanterol intervention 3: Placebo (umeclidinium/vilanterol ) intervention 4: Placebo (QVA149)
Intervention descriptions: intervention 1: QVA149 capsules for inhalation, delivered via QVA149 SDDPI intervention 2: Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler intervention 3: Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler intervention 4: Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Protocol document: