AUSTRI
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
34.0% male
N = 11679
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 µg and 50 µg, 250 µg and 50 µg, or 500 µg and 50 µg of fluticasone and salmeterol, respectively, administered BID)
N=5845 fluticasone-only inhaler therapy (at a dose of 100 µg, 250 µg, or 500 µg, administered BID)
Primary outcome
Serious asthma-related events
36
38
38.0
28.5
19.0
9.5
0.0
Fluticasone-salmeterol inhaler therapy
Fluticasone-only inhaler therapy
Difference not exceeding
nonferiority margin ✓
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.
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