Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A 12 Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy of Umeclidinium/Vilanterol 62.5/25mcg in Subjects With COPD
This study is a 12-week, multicenter, randomized, double blind, parallel group,
placebo-controlled study.
The purpose of this study is to replicate the therapeutic benefit of UMEC/VI 62.5/25
microgram (mcg) on health-related quality of life as reflected by St. George's Respiratory
Questionnaire (SGRQ) scores and symptoms as reflected by rescue medication use observed in
the 6 month placebo controlled study (DB2113373). Lung function will be assessed as it
provides an objective measure to support the subjective patient reported outcomes of SGRQ and
rescue medication use. The study is intended to provide additional evidence to support the
use of UMEC/VI for the maintenance treatment of COPD Approximately 496 subjects will be
randomized from approximately 62 centers in order to ensure 422 subjects complete 12 weeks of
treatment. Eligible subjects will be randomized to UMEC/VI 62.5/25mcg or placebo in a 1:1
ratio. All treatments will be administered once-daily in the morning via a Dry Powder Inhaler
(DPI).
There will be a total of 5 clinic visits. The total duration of study participation will be
approximately 15 weeks. All subjects will be provided with albuterol/salbutamol to use as
needed for the relief of COPD symptoms throughout the run-in and double-blind treatment
periods.
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