Last updated: 11/07/2018 05:31:58

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).

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GSK study ID
113006
See study documents
Clinicaltrials.gov ID
NCT01218126
See results summary
EudraCT ID
2010-019695-76
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in Six minute walk distance (6MWD) at Week 4, 12 and 24

Timeframe: Baseline (Week 0) and Week 4, 12, 24

Secondary outcomes:

Change from baseline in Forced expiratory volume in 1 sec (FEV1) at Week 4, 8, 12, 16, 20 and 24

Timeframe: Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24

Change from Baseline in Forced vital capacity (FVC) at Week 4, 8, 12, 16, 20 and 24

Timeframe: Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24

Change from Baseline in St Georges Respiratory Questionnaire for COPD (SGRQ-C) at Week 12 and 24

Timeframe: Baseline (Week 0) and Week 12, 24

Change from Baseline in inspiratory capacity (IC), residual volume(RV), total lung capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24

Timeframe: Baseline(Week 0) and Week 12, 24

Least square mean ratio to Baseline of plasma fibrinogen over 24 weeks

Timeframe: Baseline (Week 0) and Week 4, 8, 12, 24

Least square mean ratio to Baseline of high sensitivity C-reactive protein (HsCRP) over 24 weeks

Timeframe: Baseline (Week 0) and Week 4, 8, 12, 24

Total number of exacerbations over 24 weeks

Timeframe: Up to 24 weeks

Interventions:
  • Drug: losmapimod
  • Drug: placebo
    • Enrollment:
    604
    Primary completion date:
    2011-21-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Watz H, Barnacle H, B Hartley, Chan R .A randomised, double-blind, placebo-controlled trial of the efficacy and safety of losmapimod in patients with chronic obstructive pulmonary disease .Lancet Respir Med.2014;2(1):63-72
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    losmapimod
    Collaborators
    Not applicable
    Study date(s)
    November 2010 to December 2011
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
    • FEV1/FVC ratio of ≤0.70
    • current diagnosis of asthma
    • pregnant or lactating
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    St. Charles, Missouri, United States, 63301
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tartu, Estonia, 51014
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Praha 8, Czech Republic, 182 00
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Buenos Aires, Buenos Aires, Argentina, C1120AAC
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tabor, Czech Republic, 390 19
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tallinn, Estonia, 13619
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2011-21-12
    Actual study completion date
    2011-21-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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