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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).

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: October 7, 2010
Last updated: July 16, 2015
Last verified: July 2014
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.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: losmapimod
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Efficacy and Safety of Losmapimod (GW856553) Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD).

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Six minute walk distance (6MWD) [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Forced expiratory volume in 1 sec (FEV1) [ Time Frame: 24 weeks ]
  • Forced vital capacity (FVC) [ Time Frame: 24 weeks ]
  • St Georges Respiratory Questionnaire for COPD (SGRQ-C) [ Time Frame: 24 weeks ]
  • Plethysmography - inspiratory capacity, residual volume, total lung capacity [ Time Frame: 24 weeks ]
  • Fibrinogen [ Time Frame: 24 weeks ]
  • High sensitivity C-reactive protein (hsCRP) [ Time Frame: 24 weeks ]

Enrollment: 605
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: losmapimod Drug: losmapimod
comparison of different dosages of drug
Placebo Comparator: placebo Drug: placebo
placebo comparison with active


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01218126

  Show 48 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT01218126     History of Changes
Other Study ID Numbers: 113006
Study First Received: October 7, 2010
Last Updated: July 16, 2015

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes processed this record on April 24, 2017