GSK announces that Advair Diskus meets primary endpoint in safety study

GlaxoSmithKline has announced results from the 26-week AUSTRI postmarketing study comparing the safety of Advair Diskus fluticasone propionate/salmeterol DPI to fluticasone propionate monotherapy for the treatment of asthma. According to GSK, the study demonstrated that Advair Diskus was non-inferior to FP at three different dosage strengths for the risk of serious asthma events.

Of the 11,751 adolescent and adult patients enrolled in the study, 34 patients in the Advair Diskus arm and 33 patients in the FP arm experienced serious asthma events. There were no asthma-related deaths in either arm.

GSK said that it is about to complete a pediatric safety study called VESTRI and expects to report data from that study at the end of the first quarter of 2016.

Read the GSK press release.

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