Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
COPD is characterized by an airflow limitation, which is not fully reversible, usually
progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a
major cause of disability and anxiety associated with the disease. In addition, COPD is
associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to
improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations,
and also to improve health status and exercise tolerance.
This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to
compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5
mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD.
The primary purpose of this study is to demonstrate improvements in lung function for
subjects treated with UMEC/VI compared with UMEC for 24 weeks.
Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio.
Subjects will be stratified based on long-acting bronchodilator usage during the run-in
period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either
UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA®
dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once
daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol
(50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA
DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2
weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week.
ELLIPTA and DISKUS are trademarks of GSK group of companies.
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