Yoshihara S, et al. - In this randomized, double-blind, multicentre, controlled trial conducted in children with asthma, aged 8 months to 4 years, the efficacy and safety of fluticasone propionate 50 μg/salmeterol xinafoate 25 μg (FP/SAL) compared to fluticasone was assessed. During a 2-week run-in period, FP was administered twice daily to all children. At randomization (1:1), 300 children were administered FP/SAL or FP twice daily for 8 weeks. Outcomes suggest no superiority of FP/SAL to FP in terms of efficacy. Further, there appeared no clear add-on effect of SAL and no clinically significant differences in safety with FP/SAL usage.