Linear Growth and Bone Maturation Are Unaffected by 1 Year of Therapy With Inhaled Flunisolide Hydrofluoroalkane in Prepubescent Children With Mild Persistent Asthma: A Randomized, Double-Blind, Placebo-Controlled Trial
PURPOSE OF THE STUDY.
To determine the effect of flunisolide hydrofluoroalkane (HFA) on growth velocity and bone maturation in prepubescent children with mild persistent asthma.
A total of 249 children (Tanner stage ≤1) aged 4 to 10 years, with mild intermittent asthma, were randomized to flunisolide hydrofluoroalkane (HFA) (n = 122) or to placebo (n = 127). At study completion, 218 met criteria for inclusion in efficacy analysis (at least 3 measurements of post-baseline height).
This was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study. During a 2-week run-in period, during which albuterol was allowed for symptoms, compliance with study procedures, baseline symptom scores, and need for inhaled corticosteroids was obtained. Subjects were randomized 1:1 to 2 puffs flunisolide HFA (85 μg/puff) twice daily or 2 puffs placebo twice daily. The primary end point was growth velocity assessed by regression analysis estimated for each eligible subject by the slope of the linear regression of stadiometric height over time, expressed as cm/52 weeks. The secondary end point was change from baseline to week 53 in radiographic bone age based on bone maturation in the hand and wrist.
Flunisolide HFA 2 puffs twice daily for 1 year compared with placebo did not affect growth velocity (6.01 ± 1.84 cm/52 weeks versus 6.19 ± 1.30 cm/52 weeks, P = .425), mean change in height (6.14 ± 2.12 cm versus 6.31 ± 1.26 cm, P = .343), or bone maturation (0.93 ± 0.46 vs 1.01 ± 0.41, P = .128) in children with mild persistent asthma.
One year of chronic use of flunisolide HFA (85 μg/puff) for the treatment of mild persistent asthma did not suppress growth or bone maturation at the highest approved dose.
The topic of growth suppression with inhaled corticosteroids is an important concern for parents and physicians and may affect compliance with treatment. There was no adverse effect at this particular dose range, but we cannot assume this can be extrapolated to higher doses or other formulations. This study would be strengthened if the authors also showed the oral steroid exposure rate for each group, as increased oral steroid use among the placebo group compared with the treatment group could potentially lead to a result of no difference when one might exist. It should be noted that 2 of the authors previously worked for the company that manufactures the medicine and supported the study.
- Copyright © 2012 by the American Academy of Pediatrics