Short-term lower-leg growth rate and urine cortisol excretion in children treated with ciclesonide

J Allergy Clin Immunol. 2005 May;115(5):940-5. doi: 10.1016/j.jaci.2005.01.066.

Abstract

Background: Measurement of short-term lower-leg growth rate in children by means of knemometry has become established as an integral part of the available measures of systemic activity of topical steroids in children.

Objective: We sought to determine the effects of clinically effective doses of the novel inhaled corticosteroid ciclesonide on lower-leg growth rate and hypothalamic-pituitary-adrenal axis function in children with asthma.

Methods: In a double-blind, placebo-controlled, 4-period crossover study, 24 children aged 6 to 12 years sequentially received ciclesonide (40, 80, and 160 microg) in randomized order once daily in the evening. Each 2-week treatment period was followed by a 2-week washout period. Knemometry was performed at the beginning and end of each treatment period. Cortisol levels in 12-hour overnight urine were measured at the end of each treatment period.

Results: No statistically significant differences were seen in lower-leg growth rates between any of the ciclesonide treatments and placebo. Lower-leg growth rates were 0.412 mm/wk for placebo, 0.425 mm/wk for 40 microg of ciclesonide, 0.397 mm/wk for 80 microg of ciclesonide, and 0.370 mm/wk for 160 microg of ciclesonide. There was no statistically significant dose-response effect. Likewise, no statistically significant differences or dose-response effects were found for urinary cortisol adjusted for creatinine.

Conclusion: Short-term lower-leg growth rate and hypothalamic-pituitary-adrenal axis function are not affected by treatment with ciclesonide in doses intended for clinical use in children.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Asthma / drug therapy*
  • Asthma / pathology
  • Asthma / urine
  • Biometry
  • Body Height
  • Child
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Humans
  • Hydrocortisone / urine*
  • Leg / growth & development*
  • Leg / pathology
  • Male
  • Pregnenediones / administration & dosage
  • Pregnenediones / therapeutic use*

Substances

  • Pregnenediones
  • ciclesonide
  • Hydrocortisone