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).
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2011-21-12
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
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1120AAC
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90505
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
Ruesselsheim, Hessen, Germany, 65428
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23225
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 70868
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000DSR
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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.
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