drugset / Trial / NCT00642148

A 12 Week Study To Assess Efficacy And Safety Of GW856553 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT00642148

Phase 2 Completed 306 enrolled GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2008-02-14
Primary completion
2009-07-27
Completion
2009-07-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone propionate Other / unclassified Inhaled
Subject Losmapimod Small molecule 7.5 mg