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April 22, 2014
08:49 EDTTHRX, GSKGSK, Theravance announce Phase III study of FF/VI in Japan
GlaxoSmithKline (GSK) and Theravance (THRX) announced the start of a Phase III efficacy and safety study of a combination treatment of the inhaled corticosteroid, or ICS, fluticasone furoate and long-acting beta2 agonist, or LABA, vilanterol, or FF/VI. The study will evaluate the contribution of the ICS component on lung function, in patients with Chronic Obstructive Pulmonary Disease, or 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, multicentre, randomised, 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 enrol approximately 1580 patients from across 250 study centres worldwide, including approximately 350 patients from centres in Japan.
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