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 ug Once Daily on Growth Velocity in Prepubertal, Pediatric Participants With Well-Co

To assess the impact of low dose inhaled fluticasone furoate on growth velocity in prepubertal patients with well-controlled asthma.The study included 477 prepubertal (Tanner Stage 1) boys from 5 to <9 years of age and girls from 5 to <8 years of age with height, weight, and BMI between the third and 97th percentile. Inclusion criteria included bone age within 2 years of chronological age, asthma symptoms for ≥6 months, prebronchodilator forced expiratory flow in 1 second of ≥60%, Asthma Control Test > 19. Participants also had to receive ≥1 prescription of inhaled corticosteroids (ICS) or oral corticosteroids within ≤1 year, but could not have received ICS in ≤6 weeks or oral corticosteroids in ≤12 weeks before screening.The study was a randomized, double-blind, parallel-group, placebo-controlled trial. To minimize risk of poorly controlled asthma, all study participants were on age appropriate montelukast and either placebo or fluticasone furoate 50 ug once daily as the intervention. There was a 16-week run-in period on leukotriene receptor antagonists alone to determine baseline adherence, symptoms, and obtain baseline growth measurements, followed by a 52-week treatment period, and an 8-week follow-up period with montelukast monotherapy. The growth measurements were compared with baseline, including height SD scores, proportion of participants in the <3 percentile growth velocity values, and changes in growth velocity quartiles from baseline to endpoint.The study showed a reduction in growth velocity on fluticasone furoate of −0.16 cm per year compared with the placebo, but this crossed the confidence interval. Treatment compliance was high based on diary entry and dose counting. The change in height from baseline was similar in the treatment group versus placebo group.The height and growth velocity reduction with low dose fluticasone furoate was unlikely to be clinically significant. Limitations of the study included the duration of 1 year, whereas patients being treated for asthma as a chronic disease are usually prescribed long-term inhaled corticosteroids, and the dose used clinically can vary in comparison with the dose studied here.This study, examining the effects of low dose fluticasone furoate on growth velocity, showed safety in well controlled asthma without a statistically significant difference and, is unlikely, to be clinically relevant reduction in growth velocity and not affecting height over a short study period. The dose used in this study was a lower dose compared with most ICS used in clinical practice. This supports ICS use in pediatric asthma, emphasizing safety with ICS to treat the inflammatory component of asthma, and provides important safety information regarding appropriate prescribing of therapy for asthmatics.