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

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 μg) 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 μg of ciclesonide, 0.397 mm/wk for 80 μg of ciclesonide, and 0.370 mm/wk for 160 μg 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.

Key words: Asthma, ciclesonide, knemometry, lower-leg growth rate

Abbreviations used: ANCOVA, Analysis of covariance, Des-CIC, Desisobutyryl-ciclesonide, HFA, Hydroflouroalkane, ICS, Inhaled corticosteroid