AUSTRI
AUSTRI Asthma Safety Trial
Patient / Population Intervention / Exposition Comparaison Critère de jugement
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
Schéma
Multicentre RCT
Critère
Serious asthma-related events (death, intubation, hospitalisation)
Pertinence
2
RésultatHR 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
Discussion et critique
Refuted prior LABA safety concerns when combined with ICS; FDA removed the LABA black-box warning for combination inhalers.