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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00642148 |
Phase IIa, randomised, double-blind, double-dummy, parallel group, multi-centre study in subjects diagnosed with moderate chronic obstructive pulmonary disease (COPD). The primary objective is to evaluate the effects of 12-weeks of treatment with GW856553 7.5 mg twice daily (BID) compared with placebo on the percentage of sputum neutrophils at 12 weeks. Twelve weeks of treatment with SERETIDE 50/500 BID will be compared with placebo for effect on sputum neutrophils as a positive control arm in the study
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: GW856553 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Anti-Inflammatory Activity, Efficacy and Safety of GW856553 in Subjects With Chronic Obstructive Pulmonary Disease (COPD) |
Estimated Enrollment: | 300 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects eligible for enrolment in the study must meet all of the following criteria:
Although COPD affects the lungs, it also produces significant systemic consequences.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
inflammatory bowel disease).
Subjects who require treatment with any of the following from the Visit 1 until study completion:
A subject will not be eligible for randomisation at the end of the run-in period if either of the following criteria applies:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | MKI102428 |
Study First Received: | March 17, 2008 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00642148 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
GW856553 Chronic Obstructive Pulmonary Disease p38 MAPK |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |