Phase 2
Completed N=602
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).
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01218126 ↗
Enrolled (actual)
602
Serious AEs
9.6%
Results posted
Jan 2018
Primary outcomePrimary: Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24 — 314.4; 311.8; 313.2; 319.9 Meter (m) — p=0.517
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24 |
314.4; 311.8; 313.2; 319.9; 321.6; 322.2 | 0.517 |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24 |
2; 1; -5; 30; 9; 7 | 0.968 |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24 |
-24; -11; -55; 33; 8; -2 | 0.742 |
| SECONDARY Change From Baseline in St Georges Respiratory Questionnaire for COPD (SGRQ-C) at Week 12 and 24 |
51.1; 50.6; 52.6; 49.3; 50.6; 51.0 | 0.686 |
| SECONDARY 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 |
-26; -4; -80; 13; -9; -53 | — |
| SECONDARY Least Square Mean Ratio to Baseline of Plasma Fibrinogen Over 24 Weeks |
0.97; 0.96; 0.89; 0.87; 1.01; 0.95 | 0.157 |
| SECONDARY Least Square Mean Ratio to Baseline of High Sensitivity C-reactive Protein (HsCRP) Over 24 Weeks |
1.06; 0.93; 0.82; 0.77; 1.02; 1.06 | 0.291 |
| SECONDARY Total Number of Exacerbations Over 24 Weeks |
48; 46; 47; 34 | 0.989 |
Eligibility 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 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 35
- known or suspected history of alcohol or drug abuse within the last 2 years
Data sourced from ClinicalTrials.gov (NCT01218126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.