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GSK and Theravance announce positive results from pivotal phase iii study for fluticasone furoate/vilanterol in asthma


Friday, 6 Dec 2013 08:00am EST 

GlaxoSmithKline and Theravance Inc:Says positive results from a phase III efficacy and safety study of fluticasone furoate 'FF'/vilanterol 'VI' designed to support a potential filing for an asthma indication for adults in the US.Says for the pre-specified primary endpoint of 0-24 hour weighted mean forced expiratory volume in one second (FEV1), FF/VI 100/25mcg demonstrated a statistically improvement in lung function compared with FF 100mcg (108ml, 95% CI 45, 171 p < 0.001) at the end of the 12 week treatment period.Says in patients receiving FF/VI 200/25mcg an additional improvement of 24ml (95% CI -37, 86) was observed when compared with FF/VI 100/25mcg.