Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: functional respiratory capacity High-resolution computed tomography GSK2269557 acute exacerbation of COPD lung capacity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 126
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety, tolerability and pharmacokinetic data. The total duration of the study will be 13-14 weeks including screening, treatment period and a follow up visit. Subjects will receive once daily study treatment administration starting on Day 1. Study is planned to recruit approximately 120 subjects such that approximately 100 subjects complete the study.

Detailed description:

Arms:
arm 1: Participants will receive 2 inhalation of GSK2269557 dry powder once daily via DISKUS™ 'device' (DISKUS is a trademark of the GSK group of companies) arm 2: Participants will receive 2 inhalation matching placebo dry powder once daily via DISKUS 'device'

Interventions: intervention 1: GSK2269557 intervention 2: Placebo
Intervention descriptions: intervention 1: Dry powder for inhalation via DISKUS 'device' with unit dose strength of 500 micrograms (mcg) per actuation with total dose of 1000 mcg daily intervention 2: Dry powder for inhalation via DISKUS 'device'

Protocol document: