Rns7 Mar 2016 07:26
GlaxoSmithKline plc (LSE/NYSE:GSK) today announced publication of results from the 'LABA' (long acting beta2-agonist) safety study, AUSTRI (SAS115359) in the New England Journal of Medicine (NEJM). The study, which reported results in October, compared Advair® Diskus®, a combination of the LABA, salmeterol, and inhaled corticosteroid (ICS), fluticasone propionate (FP), to FP monotherapy, to assess the safety profiles of each medicine when used to treat adolescent and adult patients with asthma. This was assessed by the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations) and showed that Advair had a safety profile comparable to FP, including no asthma-related deaths in either arm. These results are being simultaneously presented at the American Academy of Asthma, Allergy and Immunology (AAAAI) Congress in Los Angeles, California.
AUSTRI was undertaken as a post-marketing requirement of GSK for the US Food and Drug Administration (FDA). Three other manufacturers of LABA-containing products, which are also indicated for the treatment of asthma, are undertaking 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 in adolescents and adults with asthma. AUSTRI is the first of the large-scale safety studies to report results and was conducted in over 11,000 patients.
Kate Knobil, Chief Medical Officer - Pharmaceuticals at GSK said: "We are pleased that this study, which demonstrates the safety profile of Advair, has now been presented in a well-respected, peer-reviewed journal and also presented at scientific congress. This will give physicians the opportunity to independently review the results of this study."
In addition to the AUSTRI study, GSK is also conducting a second LABA safety study, VESTRI, in children with asthma aged 4 - 11 years of age. This study is on track to report at the end of Q1 2016.