Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: long acting beta2- receptor agonist long acting muscarininc receptor antagonist dry powder inhaler safety COPD inhaled corticosteroid efficacy fluticasone furoate/vilanterol umeclidinium bromide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 620
Healthy volunteers: no

Brief summary:
After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide \[UMEC\] \[62.5 mcg\] administered once daily via a DPI; OR UMEC \[125 mcg\] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.

Detailed description:

Arms:
arm 1: Subjects received one inhalation of FF/VI 100/25 mcg via DPI followed by one inhalation UMEC (62.5mcg) via DPI once-daily in the morning for 12 weeks. arm 2: Subjects received one inhalation of FF/VI 100/25 mcg via DPI followed by one inhalation of UMEC (125mcg) via a DPI once-daily in the morning for 12 weeks. arm 3: Subjects received one inhalation of FF/VI 100/25 mcg via DPI followed by one inhalation of matching placebo via a DPI once-daily in the morning for 12 weeks.

Interventions: intervention 1: FF intervention 2: VI intervention 3: UMEC intervention 4: Placebo
Intervention descriptions: intervention 1: Dry white powder containing 100mcg of Fluticasone Furoate blended with lactose per blister was administered by DPI. intervention 2: Dry white powder containing 25mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by DPI. intervention 3: Umeclidinium bromide in a powder blend with lactose and magnesium stearate was used at two different doses 62.5mcg and 125mcg. intervention 4: The matching placebo DPI identical in appearance to the inhaler containing active study medication.

Protocol document: