Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)
Status:
Completed
Trial end date:
2017-01-16
Target enrollment:
Participant gender:
Summary
This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial
evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous
(SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar
levels as those seen in severe asthmatics. It is hypothesized that the reduction of
eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD
exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects
who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who
exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD
subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in
1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The
total duration of subject participation will be approximately 62 weeks, consisting of a 1 to
2 week screening period, 52-week treatment period and 8-week follow-up period.