GlaxoSmithKline and Theravance Inc. announced the start of a Phase 3 efficacy and safety study of a combination treatment of the inhaled corticosteroid (ICS), fluticasone furoate and long-acting beta-2 agonist (LABA), vilanterol (FF/VI). The study will evaluate the contribution of the ICS component on lung function, in patients with Chronic Obstructive Pulmonary Disease (COPD). Positive results from this study will help support a potential filing of FF/VI for the treatment of patients with COPD in Japan.The study is a 12-week, multicenter, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25mcg once daily compared with VI 25mcg once daily, administered via the Ellipta inhaler. Patients included in the study will have a history of COPD with at least one exacerbation in the year prior to screening and will demonstrate current symptoms of COPD. The study seeks to enroll approximately 1580 patients from across 250 study centers worldwide, including approximately 350 patients from centers in Japan.
The FF/VI Phase 3 clinical development program in patients with COPD contained data from six studies in over 6,000 COPD patients. Specific Japanese patient efficacy data were only available from two six-month efficacy studies. In these studies the contribution of FF 100mcg to the combination, on lung function, did not achieve statistical significance. GSK chose to withdraw the COPD file in Japan while designing an additional study, as there were insufficient data to support the efficacy of the combination and its components in this specific patient group. Demonstration of a statistically significant contribution of FF 100mcg to the combination on lung function needs to be shown in this study, with a trend demonstrating a positive benefit in the Japanese patients sub-group, being pivotal for the approval of FF/VI 100/25mcg for treatment of COPD in Japan.
Date: April 22, 2014
Source: GSK
