Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstr

• Status: Completed
• Trial end date: 2011-12-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society

• FEV1/FVC ratio of ≤0.70

• FEV1 ≤ 80% of predicted normal

• 6MWD < 350m

• male or female outpatients aged ≥40 years of age

• current or prior history of ≥10 pack-years of cigarette smoking

• aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN)

• alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

• QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG.

Exclusion Criteria:

• current diagnosis of asthma

• pregnant or lactating

• α1-antitrypsin deficiency

• lung resection

• chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD

• exacerbation of COPD within previous 12 weeks

• treatment with roflumilast within previous 2 weeks and throughout the treatment period

• lower respiratory tract infection that required the use of antibiotics within previous 12 weeks

• long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day

• participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study

• carcinoma that has not been in complete remission for at least 5 years

• current or chronic history of liver disease

• positive Hepatitis B surface antigen or positive Hepatitis C antibody

• Body Mass Index (BMI) > 35

• known or suspected history of alcohol or drug abuse within the last 2 years