Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 357
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: Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. arm 2: Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.

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 single dose dry powder inhaler (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: