Recent guidelines recommend intranasal corticosteroids as first-line treatment for managing persistent symptoms of moderate to severe allergic rhinitis (AR). However, in children, long-term continual treatment with corticosteroids has raised concerns about potential growth suppression.Objective:
To evaluate the effects of the recommended once-daily dose of budesonide aqueous nasal spray on growth velocity, as measured with stadiometry, in children with perennial AR.Methods:
In this double-blind, placebo-controlled, multicenter study, 229 prepubertal children (mean age, 5.9 years; age range, 4–8 years) with perennial AR were randomized (2:1) to receive budesonide aqueous nasal spray, 64 μg (32 μg per nostril) once daily, or placebo for 1 year. The change from baseline in growth velocity, height after treatment, and the percentage of patients whose percentile for height decreased from baseline to the end of treatment were evaluated.Results:
Growth velocity was not significantly different between the 2 groups. The least-squares mean ± SE growth velocity during treatment was 5.91 ± 0.11 cm per year for children receiving budesonide and 6.19 ± 0.16 cm per year for those receiving placebo. The mean difference in growth velocity between the 2 groups was 0.27 ± 0.18 cm per year (95% confidence interval, −0.07 to 0.62 cm per year). After treatment, the mean ± SD height was 128.8 ± 8.7 cm for children receiving budesonide and 128.2 ± 8.8 for those receiving placebo. The percentage of children whose percentile for height decreased during treatment was not significantly different between the 2 groups (budesonide, 59%, placebo, 54%; P = .64). The incidence and types of adverse events and the mean 24-hour urinary cortisol-creatinine ratio were similar for the 2 groups.Conclusions:
Treatment with budesonide aqueous nasal spray, 64 μg once daily, for 1 year did not suppress growth velocity compared with placebo and was well tolerated in prepubertal children with perennial AR.