The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age

BACKGROUND: Fluticasone propionate 50 μg/salmeterol xinafoate 25 μg (FP/SAL) is widely used in adults and children with asthma, but there is sparse information on its use in very young children. METHODS: This was a randomized, double‐blind, multicentre, controlled trial conducted in children aged 8 months to 4 years. During a 2‐week run‐in period, they all received FP twice daily. At randomization, they commenced FP/SAL or FP twice daily for 8 weeks. All were then given FP/SAL only, in a 16‐week open‐label study continuation. Medications were inhaled through an AeroChamber Plus with attached face mask. The primary end‐point was mean change in total asthma symptom scores from baseline to the last 7 days of the double‐blind period. Analyses were undertaken in all children randomized to treatment and who received at least one dose of study medication. RESULTS: Three hundred children were randomized 1:1 to receive FP/SAL or FP. Mean change from baseline in total asthma symptom scores was –3.97 for FP/SAL and –3.01 with FP. The between‐group difference was not statistically significant (P = 0.21; 95% confidence interval: −2.47, 0.54). No new safety signals were seen with FP/SAL. CONCLUSION: This is the first randomized, double‐blind study of this size to evaluate FP/SAL in very young children with asthma. FP/SAL did not show superior efficacy to FP; no clear add‐on effect of SAL was demonstrated. No clinically significant differences in safety were noted with FP/SAL usage.