Shigemi Yoshihara, Toshikazu Tsubaki, Masanori Ikeda, Warren Lenney, Richard Tomiak, Takako Hattori, Kenichi Hashimoto, Toru Soutome, Shihona Kato
Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology 2019 MarFluticasone 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. 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. 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. 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. © 2018 The Authors. Pediatric Allergy and Immunology Published by John Wiley & Sons Ltd.
Shigemi Yoshihara, Toshikazu Tsubaki, Masanori Ikeda, Warren Lenney, Richard Tomiak, Takako Hattori, Kenichi Hashimoto, Toru Soutome, Shihona Kato. The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age. Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology. 2019 Mar;30(2):195-203
PMID: 30556939
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