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.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01218126
First received: October 7, 2010
Last updated: July 10, 2014
Last verified: December 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Forced expiratory volume in 1 sec (FEV1) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Forced vital capacity (FVC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • St Georges Respiratory Questionnaire for COPD (SGRQ-C) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Plethysmography - inspiratory capacity, residual volume, total lung capacity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Fibrinogen [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • High sensitivity C-reactive protein (hsCRP) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218126

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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01218126     History of Changes
Other Study ID Numbers: 113006
Study First Received: October 7, 2010
Last Updated: July 10, 2014
Health Authority: Argentina: Ministry of Health - A.N.M.A.T
Ukraine: The Central Ethics Committee of Ministry of Health of Ukraine
United States: Food and Drug Administration
Norway: Norwegian Medicines Agency
Korea: Food and Drug Administration
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014