A multicenter randomized, double‐blind, placebo‐controlled, parallel‐group study to evaluate the effects of a 1‐year regimen of orally inhaled fluticasone furoate 50 µg once daily on growth velocity in prepubertal, pediatric participants with well‐controlled asthma

Abstract

AbstractIntroduction: Growth impairment is a known adverse event (AE) of corticosteroids in children. This study aimed to assess the effect of once‐daily (QD) inhaled fluticasone furoate (FF) versus placebo on growth velocity over 1 year in prepubertal children with well‐controlled asthma.Materials and Methods: This randomized, double‐blind, parallel‐group, placebo‐controlled, multicenter study (NCT02889809) included prepubertal children, aged 5 to <9 years (boys), and 5 to <8 years (girls), with ≥6 months' asthma history. Children received inhaled placebo QD plus background open‐label montelukast QD for a 16‐week run‐in period and were then randomized 1:1 to receive inhaled FF 50 μg QD or placebo QD (whilst continuing background open‐label montelukast) for a 52‐week treatment period. The primary endpoint was the difference in growth velocity (cm/year) over the treatment period. Other growth endpoints were measured, as were incidence of AEs and asthma exacerbation. Growth analyses included all intent‐to‐treat (ITT) participants with ≥3 post‐randomization, on‐treatment clinic visit height assessments (GROWTH population).Results: Of 644 children in the run‐in period, 477 (mean age 6.2 years, 63% male) entered the 52‐week treatment period (ITT population: FF N = 238, placebo N = 239; GROWTH population: N = 457 [FF N = 231; placebo N = 226]). The least‐squares mean difference in growth velocity for FF versus placebo was –0.160 cm/year (95% confidence interval: –0.462, 0.142). There were no new safety signals.Conclusions: Over 1 year, FF 50 μg QD had a minimal effect on growth velocity versus placebo, with no new safety signals.