Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD Safety FEV1 Efficacy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 54
Healthy volunteers: no

Brief summary:
The Purpose of this study is to evaluate the 24-hour spirometry effect Forced Expiratory Volume in One second (FEV1) of 3 doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the end of a 28-day treatment period in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with placebo. Other objectives are to assess additional efficacy, plus the safety, pharmcodynamics and tolerability of concurrent treatment with Fluticasone Furoate (FF) plus GW642444 when administered at three dose levels for 28 days in subjects with COPD and to assess the steady-state pharmacokinetic profile of Fluticasone Furoatee (FF) and GW642444 at the end of each treatment period.

Detailed description:

Arms:
arm 1: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 2: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 3: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 4: placebo

Interventions: intervention 1: Fluticasone Furoate (FF)/GW642444 Inhalation Powder intervention 2: placebo
Intervention descriptions: intervention 1: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD intervention 2: placebo

Protocol document: