GlaxoSmithKline’s Advair Diskus — a combination of the LABA salmeterol and the inhaled corticosteroid fluticasone propionate (FP) — had a safety profile comparable to FP monotherapy when used to treat adolescent and adult patients with asthma, according to results of the LABA safety study AUSTRI (SAS115359).
Results from the 26-week AUSTRI study, which randomized 11,751 patients across 33 countries, showed Adair Diskus twice-daily (100/50 mcg, 250/50 mcg or 500/50 mcg) demonstrated non-inferiority compared to corresponding doses of FP twice-daily (100 mcg, 250 mcg or 500 mcg), 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 Adair Diskus 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.
AUSTRI was undertaken as a post-marketing requirement of GSK for the US FDA. Three other manufacturers of LABA-containing products, which are also indicated for the treatment of asthma, undertook identical studies designed to evaluate whether the addition of a LABA to an ICS increased the risk of an event in the composite endpoint of serious asthma-related events (deaths, intubations or hospitalizations) in adolescents and adults.
AUSTRI is the first of the large-scale safety studies to report results. These findings will be shared with the FDA to discuss next steps.
More information is available on the GSK website.