Clinical Edge

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Is Salmeterol Added to Fluticasone Safe in Children?

N Engl J Med; 2016 Sep 1; Stempel, Szefler, et al

In children with asthma, adding salmeterol in a fixed-dose combination with fluticasone was associated with the risk of a serious asthma-related event that was similar to the risk with fluticasone alone. This according to a trial of 6,208 children aged 4 to 11 years who required daily asthma medications and with a history of asthma exacerbations randomly assigned in a 1:1 ratio to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks. Researchers found:

  • 27 patients in the fluticasone-salmeterol group and 21 in the fluticasone-alone group had a serious asthma-related event.
  • Hazard ratio with fluticasone-salmeterol vs fluticasone alone was 1.28, showing the noninferiority of fluticasone-salmeterol.
  • 265 patients (8.5%) in the fluticasone-salmeterol group and 309 (10.0%) in the fluticasone-alone group had a severe asthma exacerbation (HR, 0.86).


Stempel DA, Szefler SJ, Pedersen S, et al. Safety of adding salmeterol to fluticasone propionate in children with asthma. N Engl J Med. 2016;375:840-849. doi:10.1056/NEJMoa1606356.