AUSTRI
AUSTRI Asthma Safety Trial
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 11,679 adolescents and adults with moderate-to-severe asthma, fluticasone-salmeterol was non-inferior for serious asthma-related events compared with fluticasone alone.
N
11.679
Disegno
Multicentre RCT
Esito
Serious asthma-related events (death, intubation, hospitalisation)
Rilevanza
2
RisultatoHR 1.03 (95% CI 0.64–1.66); severe exacerbations HR 0.79 (p<0.001).
Stempel DA, et al. N Engl J Med. 2016;374(19):1822-1830. 10.1056/NEJMoa1511049
Discussione e critica
Refuted prior LABA safety concerns when combined with ICS; FDA removed the LABA black-box warning for combination inhalers.