Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 604
Healthy volunteers: no

Brief summary:
Randomised, double-blind, parallel-group, multi-centre study evaluating three doses of losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (BID) versus placebo on exercise tolerance. Eligible subjects will be randomised to treatment after a one-week run-in period. The duration of the treatment period is 24 weeks. An estimated 1000 subjects will be screened to reach the target enrolment of approximately 600 randomised subjects.

Detailed description:

Arms:
arm 1: losmapimod 2.5 mg arm 2: None arm 3: losmapimod 7.5 mg arm 4: losmapimod 15 mg

Interventions: intervention 1: losmapimod intervention 2: placebo
Intervention descriptions: intervention 1: comparison of different dosages of drug 2.5 mg, 7.5 mg or 15 mg intervention 2: placebo comparison with active

Protocol document: