Status:
COMPLETED
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 Obstructive Pulmonary Disease (COPD).
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2011
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT01218126
Start Date
November 4 2010
End Date
December 21 2011
Last Update
February 6 2018
Active Locations (48)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294
2
GSK Investigational Site
Torrance, California, United States, 90505
3
GSK Investigational Site
Rochester, Minnesota, United States, 55905
4
GSK Investigational Site
Saint Charles, Missouri, United States, 63301