Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 617
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 fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Detailed description:
This is a mutlicenter, randomized, double-blind, parallell-group study. Subejcts 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), 62.5mcg plus Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg arm 2: Long-acting muscarinic antagonist (LAMA), 125mcg plus Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg arm 3: Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg

Interventions: intervention 1: Umeclidinium bromide 62.5mcg intervention 2: Umeclidinium bromide 125mcg intervention 3: Fluticasone propionate 250mcg/Salmeterol 50mcg intervention 4: Placebo
Intervention descriptions: intervention 1: Inhalation Powder, LAMA 62.5mcg intervention 2: Inhalation Powder, LAMA 125mcg intervention 3: Inhalation Powder, ICS/LABA intervention 4: Inhalation Powder, Placebo

Protocol document: