At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of GSK2269557 Administered in Addition to Standard of Care in Adult Subjects Diagnosed With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
In Brief
A Phase 2 clinical trial evaluating GSK2269557 and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 126 participants across 17 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
Dry powder for inhalation via DISKUS 'device' with unit dose strength of 500 micrograms (mcg) per actuation with total dose of 1000 mcg daily
Dry powder for inhalation via DISKUS 'device'