Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Effect of the Combination of Umeclidinium and Vilanterol on Exercise Endurance Time in Subjects With COPD
This is a multicenter, randomized, double-blind, placebo-controlled, 2-period, complete block
design cross-over study.
The purpose of this study is to evaluate the effect of UMEC/VI 62.5/25 microgram (mcg) on EET
as measured by the Endurance Shuttle Walk Test (ESWT) compared to placebo. Additionally, the
effect of UMEC/VI compared to placebo on lung function and lung volumes in COPD patients will
be characterized.
Approximately 298 participants will be screened and, assuming 35% of these will not be
eligible for randomization; approximately 194 participants will be randomized.
Eligible participants will be randomized 1:1 to one of 2 treatment sequences. In sequence 1
participants will receive UMEC/VI 62.5/25 mcg in Treatment Period 1 and placebo in Treatment
Period 2. In sequence 2 participants will receive placebo in Treatment Period 1 and UMEC/VI
62.5/25 mcg in Treatment Period 2. Treatments will be delivered once-daily via a dry powder
inhaler (DPI). Each treatment period will be for 12 weeks and will be separated by a wash out
period of 12-17 days. The total duration of patient participation, including the Follow-Up
will be approximately 30 weeks. All participants will be provided with albuterol for use on
an "as needed (prn)" basis throughout the run-in, washout and study treatment periods while
on investigational product.
n/a
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