6/28/23, 12:49 AM AUSTRI Pathway Feedback Search Clinical Topics Home Studies AUSTRI AUSTRI Disease Disease Asthma Severe asthma phenotypes Trial question Is salmeterol plus fluticasone noninferior to fluticasone alone in patients with persistent asthma and a history of severe asthma exacerbations? Study design Multi-center Double blinded RCT Population Characteristics of study participants 66.0% female N = 11679 34.0% male 11679 patients (7749 female, 3930 male) Inclusion criteria: patients with persistent asthma who had a history of a severe asthma exacerbation in the year before randomization, but not during the previous month Key exclusion criteria: history of life-threatening, cigarette smoking for > 10 pack-years or unstable asthma Interventions N=5834 fluticasone-salmeterol inhaler therapy (at a dose of 100 g and 50 g, 250 g and 50 g, or 500 g and 50 g of fluticasone and salmeterol, respectively, administered BID) N=5845 fluticasone-only inhaler therapy (at a dose of 100 g, 250 g, or 500 g, administered BID) https://web.pathway.md/studies/recf6VZ4PKqxQFopX 1/2 6/28/23, 12:49 AM AUSTRI Pathway Primary outcome Serious asthma-related events 38.0 38 36 28.5 19.0 Difference not exceeding nonferiority margin 9.5 0.0 Fluticasone-salmeterol inhaler therapy Fluticasone-only inhaler therapy Difference not exceeding nonferiority margin in serious asthma-related events (36 vs. 38; HR 1.03, 95% CI 0.64 to 1.66) Secondary outcomes Significant decrease in severe asthma exacerbation, at least one (8% vs. 10%; HR 0.79, 95% CI 0.7 to 0.89) Safety outcomes No significant difference in asthma-related hospitalizations (34 vs. 33) and there were no reported asthma-related death in either group. Conclusion In patients with persistent asthma who had a history of a severe asthma exacerbation in the year before randomization, but not during the previous month, fluticasone-salmeterol inhaler therapy was noninferior to fluticasone-only inhaler therapy with respect to serious asthma-related events. Reference Stempel DA, Raphiou IH, Kral KM et al. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. N Engl J Med. 2016 May 12;374(19):1822-30. Open reference URL https://web.pathway.md/studies/recf6VZ4PKqxQFopX 2/2