Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Novel Dry Powder Inhaler (NDPI) umeclidinium bromide (UMEC) GSK573719 lung function GW642444 salmeterol (SAL) fluticasone propionate (FP) vilanterol (VI) Chronic obstructive pulmonary disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 717
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with Chronic Obstructive Pulmonary Disease (COPD). Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 500/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.

Detailed description:

Arms:
arm 1: Subjects will receive UMEC/ VI 62.5/25 mcg, one inhalation administered once-daily in the morning via the NDPI and one placebo ACCUHALER/DISKUS administered as one inhalation each morning and evening. arm 2: Subjects will receive FSC 500/50 mcg, administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once daily in the morning via NDPI.

Interventions: intervention 1: Umeclidinium bromide/Vilanterol intervention 2: Placebo ACCUHALER/DISKUS intervention 3: Fluticasone propionate/Salmeterol intervention 4: Placebo NDPI
Intervention descriptions: intervention 1: Dry white powder of UMEC 62.5 mcg per blister and VI 25 mcg per blister as NDPI with 30 doses (2 strips with 30 blisters per strip). intervention 2: Dry white powder of matching placebo as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip). intervention 3: Dry white powder of fluticasone propionate 500 mcg per blister 50 mcg salmeterol per blister as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip). intervention 4: Dry white powder of matching placebo as NDPI with 30 doses (2 strips with 30 blisters per strip).

Protocol document: