Safety study results for Advair Diskus (salmeterol + fluticasone propionate) for Asthma- GlaxoSmithKline

GlaxoSmithKline has announced results from the safety study AUSTRI (SAS115359) comparing Advair Diskus, a combination of the LABA salmeterol and the inhaled corticosteroid (ICS) fluticasone propionate (FP), to FP monotherapy and showed that Advair (FSC) had a safety profile comparable to FP when used to treat adolescent and adult patients with asthma, assessed by the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations).

Results from the 26-week AUSTRI study, which randomised 11,751 patients across 33 countries into the study, showed FSC twice-daily (100/50 µg, 250/50 µg or 500/50 µg) demonstrated non-inferiority compared to corresponding doses of FP twice-daily (100 µg, 250 µg or 500 µg), on the risk of serious asthma-related events. No asthma-related deaths were seen in either arm of the study. There were a total of 67 patients with serious asthma-related events across the study with 34 patients with events on FSC treatment and 33 patients with events on FP treatment. There were two asthma-related intubations in the trial, both in the FP arm; the remaining events were asthma-related hospitalisations.