Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Study to Evaluate the Efficacy and Safety of 15mg BID Losmapimod (GW856553) Compared to Placebo in Frequently Exacerbating Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This is a randomised, double-blind, parallel-group, multi-centre study evaluating 15
milligram (mg) twice daily/ Bi-daily (BID) of losmapimod versus placebo, in addition to
standard of care (SoC).
The primary objective of this study is to explore the therapeutic potential of losmapimod as
a treatment to reduce the rate of exacerbations in the subset of participants with
moderate-to-severe COPD who are at high risk of exacerbation, having experienced two or more
moderate/severe exacerbations in the preceding 12 months, and who have <=2% of blood
eosinophils at screening. As secondary objectives safety, effects on lung function, quality
of life, pharmacokinetic (PK), biomarkers of both disease and inflammation shall be
evaluated.
The duration of the treatment period is variable but will be at least 26 weeks and up to a
maximum of 52 weeks, with the end of study date being established once the final participant
has been randomized. The purpose of the variable dosing regimen is to enable participants to
remain in the study for a longer duration, as it is anticipated that this will increase the
likelihood of observing exacerbation events without increasing the overall study duration. It
will also enable safety data on dosing periods beyond 6 months to be generated.
Approximately 200 participants in a 1:1 ratio between losmapimod and placebo will be
randomized to the study. Sample size re-estimation will be performed during the course of the
study to potentially increase the sample size up to a maximum of 600 participants.
n/a
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