@article{793dcee3156845df9c5ae6ccc9e11930,
title = "The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age",
abstract = "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.",
keywords = "asthma, child, combination therapy, double-blind, fluticasone propionate, randomized, salbutamol, salmeterol",
author = "Shigemi Yoshihara and Toshikazu Tsubaki and Masanori Ikeda and Warren Lenney and Richard Tomiak and Takako Hattori and Kenichi Hashimoto and Toru Soutome and Shihona Kato",
note = "Funding Information: Funding for this study was provided by GSK. All listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors. The authors would like to thank all chil‐ dren/parents, investigators and investigator centre staff members who participated in this study. Medical writing and editorial support in the form of development of draft outline based on author input, development of manuscript (all drafts), assembling tables and collat‐ ing author comments was provided by Dr Kathryn White of Cathean Ltd and was funded by GSK. All participating principal investigators are listed; see Online Repository. Funding Information: Funding information The study was funded by GlaxoSmithKline. Study drug, rescue medication and AeroChamber Plus with face masks (Trudell Medical International, Canada) were provided by GlaxoSmithKline KK (Tokyo Japan). Funding for this study was provided by GSK. All listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors. The authors would like to thank all children/parents, investigators and investigator centre staff members who participated in this study. Medical writing and editorial support in the form of development of draft outline based on author input, development of manuscript (all drafts), assembling tables and collating author comments was provided by Dr Kathryn White of Cathean Ltd and was funded by GSK. All participating principal investigators are listed; see Online Repository. Publisher Copyright: {\textcopyright} 2018 The Authors. Pediatric Allergy and Immunology Published by John Wiley & Sons Ltd",
year = "2019",
month = mar,
doi = "10.1111/pai.13010",
language = "English",
volume = "30",
pages = "195--203",
journal = "Pediatric Allergy and Immunology",
issn = "0905-6157",
publisher = "Blackwell Munksgaard",
number = "2",
}