Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 608
Healthy volunteers: no

Brief summary:
The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Detailed description:
This is a multicenter, randomized, double-blind, parallel-group study. Subjects who meet the eligibility criteria at screening and meet the randomization criteria at the end of a 4 week run-in period will enter a 12 week treatment period. There will be a 7 day follow-up period after the treatment period.

Arms:
arm 1: Long-acting muscarinic antagonist (LAMA) arm 2: Inhaled corticosteroid (ICS)/Long-acting beta agonist (LABA)

Interventions: intervention 1: Umeclidinium bromide 62.5mcg intervention 2: Umeclidinium bromide 125mcg intervention 3: Fluticasone propionate 250mcg/Salmeterol 50mcg
Intervention descriptions: intervention 1: Inhalation powder intervention 2: Inhalation powder intervention 3: Inhalation powder

Protocol document: