Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Study MEA117106: Mepolizumab vs. Placebo as add-on Treatment for Frequently Exacerbating COPD Patients
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial
evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC)
injection.
In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in
severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in
COPD patients would translate into a reduction of COPD exacerbations. The study will
determine the reduction in exacerbations in subjects who are above and below the baseline
blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the
efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in
COPD subjects at high risk of exacerbations, despite the use of optimized standard of care
background therapy.
Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive
placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study
will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week
treatment period and 8-week follow-up period.
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