Growth velocity in children with perennial allergic rhinitis treated with budesonide aqueous nasal spray

Ann Allergy Asthma Immunol. 2006 May;96(5):723-30. doi: 10.1016/S1081-1206(10)61072-1.

Abstract

Background: 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 microg (32 microg 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 microg once daily, for 1 year did not suppress growth velocity compared with placebo and was well tolerated in prepubertal children with perennial AR.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / adverse effects*
  • Body Height / drug effects*
  • Budesonide / administration & dosage
  • Budesonide / adverse effects*
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Male
  • Rhinitis, Allergic, Perennial / drug therapy*
  • Time Factors

Substances

  • Anti-Inflammatory Agents
  • Budesonide