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Dec 09, 2013
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Fluticasone furoate/vilanterol: Phase III data

A double-blind, international Phase III trial in 990 patients with moderate to severe persistent asthma showed that once-daily 100/25 µg fluticasone furoate/vilanterol administered with the dry powder Ellipta inhaler met the primary endpoint of improving 0-24 hour weighted mean serial FEV1 at the end of the 12-week treatment period vs. once-daily 100 µg fluticasone furoate. Specifically, 100/25 µg fluticasone furoate/vilanterol improved FEV1 by 108 mL compared to fluticasone furoate (p<0.001). GlaxoSmithKline said that the once-daily 200/25 µg dose of fluticasone furoate/vilanterol led to an additional improvement in FEV1 of 34 mL when compared to the 100/25 µg dose. The primary endpoint only evaluated the low-dose of fluticasone furoate/vilanterol vs. fluticasone furoate. The most common adverse events reported across all treatment arms were headache, nasopharyngitis, upper respiratory tract infection and influenza infection.

The pharma said the data "will inform" its discussions with FDA on the "regulatory...

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