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 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.


CONCLUSIONS
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.
Agertoft
Lone
L
Department of Paeditrics, University of Southern Denmark, Kolding Hospital, Denmark. Lone_Agertoft@dadlnet.dk
Pedersen
Søren
S
D000280:Administration, Inhalation; D001249:Asthma / Q000188:drug therapy* / Q000473:pathology / Q000652:urine; D001699:Biometry; D001827:Body Height; D002648:Child; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000652:urine*; D007866:Leg / Q000254:growth & development* / Q000473:pathology; D008297:Male; D011282:Pregnenediones / Q000008:administration & dosage / Q000627:therapeutic use*
D011282:Pregnenediones; C120481:ciclesonide; D006854:Hydrocortisone