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 (COPD).

GlaxoSmithKline Research & Development0 sites675 target enrollmentSeptember 15, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Research & Development
Enrollment: 675
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 15, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research & Development

Eligibility Criteria

Inclusion Criteria

•1\.COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society \[Celli, 2004].
•2\.Severity of Disease:
•Subjects with a measured post\-salbutamol/albuterol FEV1/FVC ratio of \=0\.70 at Screening (Visit 1\) \[Pelligrino, 2005]
•Subjects with a measured post\-salbutamol/albuterol FEV1 \<80% of predicted normal values calculated (via centralised vendor equipment) using NHANES III reference equations \[Hankinson, 1999] at Screening (Visit 1\).
•3\.Six minute walk distance (6MWD): Subjects with a 6MWD \< 350m at each Screening walk. In the opinion of the investigator, the subject’s exercise limitation must be primarily due to their COPD. Patients must be able to perform this test without the use of a walking aid or external oxygen supply.
•4\.Type of subject: Male or female outpatients aged \>40 years of age at Screening (Visit 1\). (Contraceptive conditions apply)
•5\.Tobacco use: Subjects with a current or prior history of ?10 pack\-years of cigarette smoking at Screening (Visit 1\). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1\.
•One pack year \= 20 cigarettes smoked per day for 1 year or the equivalent.
•Number of pack years \= (number of cigarettes per day/20\) x number of years smoked
•6\.Liver criteria: Subjects with the following liver function test values:

Exclusion Criteria

•1\.Pregnancy: Women who are pregnant or lactating or are planning to become pregnant during the study.
•2\.Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
•3\.?1\-antitrypsin deficiency: Subjects with ?1\-antitrypsin deficiency as the underlying cause of COPD.
•4\.Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. Subjects with allergic rhinitis are not excluded.
•5\.Lung resection: Subjects who have undergone lung resection surgery (e.g., lung volume reduction surgery or lobectomy).
•6\.Chest X\-ray (or CT scan): Subjects with a chest X\-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X\-ray must be taken at Screening (Visit 1\) if a chest X\-ray or CT scan is not available within 12 months prior to Visit 1\. For sites in Germany, if a chest X\-ray (or CT scan) is not available in the 12 months preceding Screening (Visit1\), the subject will not be eligible for the study.
•7\.Recent exacerbation of COPD: Subjects with poorly controlled COPD which required the use of antibiotics, systemic corticosteroids and/or emergency treatment or hospitalisation within 12 weeks prior to Visit 1\.
•8\.Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 12 weeks prior to Visit 1\.
•9\.Oxygen therapy: Subjects receiving treatment with long\-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., ?12 hours per day) is not exclusionary.
•10\.Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or other non\-invasive positive pressure ventilation (NIPPV) device.