Title
Randomized Trial of Once-Daily Fluticasone Furoate in Children with Inadequately Controlled Asthma
Date Issued
01 November 2016
Access level
open access
Resource Type
journal article
Author(s)
Oliver A.
Covar R.
Goldfrad C.
Klein R.
Pedersen S.
Sorkness C.
Tomkins S.
Grigg J.
Publisher(s)
Mosby Inc.
Abstract
Objective To evaluate the dose-response, efficacy, and safety of fluticasone furoate (FF; 25 µg, 50 µg, and 100 µg), administered once daily in the evening during a 12-week treatment period to children with inadequately controlled asthma. Study design This was a Phase IIb, multicenter, stratified, randomized, double-blind, double-dummy, parallel-group, placebo- and active-controlled study in children aged 5-11 years with inadequately controlled asthma. The study comprised a 4-week run-in period, 12-week treatment period, and 1-week follow-up period. Children were randomized to receive either placebo once daily, fluticasone propionate (FP) 100 µg twice daily, FF 25 µg, FF 50 µg, or FF 100 µg each once daily in the evening. Primary endpoint was the mean change from baseline in daily morning peak expiratory flow (PEF) averaged over weeks 1-12. Adverse events (AEs) also were investigated. Results In total, 593 children were included in the intent-to-treat population. The difference vs placebo in change from baseline daily morning PEF averaged over weeks 1-12 was statistically significant for the FF 25, FF 50, FF 100, and FP 100 groups (18.6 L/min, 19.5 L/min, 12.5 L/min, and 14.0 L/min, respectively; P < .001 for all). The incidence of AEs was greater in the FF groups (32%-36%) than in the placebo group (29%); the most frequent AE was cough. Conclusion FF and FP resulted in significant improvements in morning PEF compared with placebo, suggesting that they are effective treatments for children with inadequately controlled asthma. All treatments were well tolerated; no new safety concerns were identified. Trial registration ClinicalTrials.gov: NCT01563029.
Start page
246
End page
253.e2
Volume
178
Language
English
OCDE Knowledge area
Farmacología, Farmacia Sistema respiratorio
Scopus EID
2-s2.0-84994715786
PubMed ID
Source
Journal of Pediatrics
ISSN of the container
00223476
Sponsor(s)
Funded by GlaxoSmithKline (GSK; 106855 ), which was involved in the study design; the collection, analysis, and interpretation of data; the writing of the report; and the decision to submit the manuscript for publication. A.O., C.G., and S.T. are employees of and hold stocks/shares in GSK. R.C. is supported by the National Heart Lung Blood Institutes, GSK, Roche, and AstraZeneca and serves as a consultant for GSK. J.G. has received honoraria, travel, and accommodation expenses to attend a GSK advisory board. S.P. has received lecture fees from AstraZeneca and Boehringer Ingelheim and serves as a consultant for GSK and Sandoz. The other authors declare no conflicts of interest. The PEF results in our study demonstrate a positive treatment effect on lung function; however, the effect on FEV 1 is less clear. Although FF treatment resulted in an increase from baseline of between 150 mL and 254 mL at week 12, this was not significantly different from placebo for the 50 µg and 100 µg FF groups, mainly because of the pronounced placebo response. The increase in FEV 1 vs placebo was notably greater for the FF 25 µg treatment than the other FF doses and the FP 100 µg treatment. The reason for this is unclear, but because all 3 FF doses were effective on PEF, it is possible this observation is due in part to the difficulty in obtaining good quality spirometry in children. This is supported by the post hoc analyses of FEV 1 by age and acceptable FEV 1 measurements.
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