Austri, a Large Randomized Study in Adolescents and Adults with Asthma, Assessing the Safety and Efficacy of Salmeterol in Combination with Fluticasone Propionate Compared to Fluticasone Propionate Alone
Sunday, March 6, 2016
South Exhibit Hall H (Convention Center)
David A. Stempel, MD FAAAAI, Ibrahim Raphiou, PhD, Kenneth Kral, Anne Yeakey, Kathy Buaron, Amanda Emmett, Charlene M. Prazma, PhD, Steve Pascoe, MD
Rationale: Previous studies have shown an excess of serious asthma-related outcomes, including death, in subjects taking Long Acting Beta Agonists (LABAs). This study was designed to examine the risks and/or benefits of LABA therapy when added to an ICS in a combination inhaler in patients with asthma.

Methods: A global, randomized, double-blind, parallel group study of asthmatic subjects ≥12 years; treated with salmeterol (SAL) and fluticasone propionate (FP) in combination (FSC) or FP alone for 26 weeks. The primary endpoint was time to first serious asthma-related event, the composite of death, intubation or hospitalization. To declare non-inferiority the hazard ratio of subjects with a serious asthma-related event with FSC compared to FP was <2.0 based on the upper bound of the 95% confidence interval (CI) on the estimate of the hazard ratio. The secondary endpoint was time to first asthma exacerbation requiring OCS.

Results: Of 11,751 subjects randomized, 67 subjects experienced 74 serious asthma-related events with 34 and 33 subjects treated with FSC and FP, respectively. The FSC/FP hazard ratio was 1.029 (0.638-1.662) for time to first serious asthma-related event. Non-inferiority was achieved. There were no asthma-related deaths and 2 asthma-related intubations (both on FP). The FSC/FP hazard ratio for time to first asthma exacerbation was 0.787 (0.698-0.888).

Conclusions: There was no evidence of an increased risk of serious asthma-related events when SAL was used in a combination product with FP compared to FP.  There was a significant reduction in risk of asthma exacerbations for FSC compared to FP alone.