Published online December 10, 2007
PEDIATRICS Vol. 121 No. 1 January 2008, pp. e1-e14 (doi:10.1542/peds.2006-2206)

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ARTICLE

Assessment of the Long-term Safety of Inhaled Ciclesonide on Growth in Children With Asthma

David P. Skoner, MD^a,b, Jorge Maspero, MD^c, Donald Banerji, MD^d and the Ciclesonide Pediatric Growth Study Group

^a Department of Pediatrics, Allegheny General Hospital, Pittsburgh, Pennsylvania
^b Department of Pediatrics, Drexel University College of Medicine, Philadelphia, Pennsylvania
^c Sanatorio San José, Fundacion Cidea, Buenos Aires, Argentina
^d sanofi-aventis US, Bridgewater, New Jersey

OBJECTIVE. To assess the effects of the new inhaled corticosteroid ciclesonide on growth in children with asthma.

METHODS. We performed a multicenter, randomized, double-blind, placebo-controlled study to assess the effects of inhaled ciclesonide on growth in children with mild, persistent asthma. After a 6-month run-in period, 661 prepubertal children who were aged 5.0 to 8.5 years were randomly assigned to once-daily morning treatment for 1 year with ciclesonide 40 or 160 µg (ex-actuator) or placebo, followed by a 2-month follow-up period. The primary end point was the linear growth velocity (linear regression estimate) over the double-blind treatment period. Growth was recorded as the median of 4 stadiometer measurements. Adverse events and 10-hour overnight and 24-hour urinary free cortisol levels were also assessed.

RESULTS. Mean linear growth velocity during run-in was comparable between groups: 160 µg, 6.20 cm/year; 40 µg, 6.59 cm/year; placebo, 6.49 cm/year. Mean differences from placebo (5.75 cm/year) in growth velocity over the double-blind treatment period were –0.02 cm/year for ciclesonide 40 µg and –0.15 cm/year for ciclesonide 160 µg. Both ciclesonide treatments were noninferior to placebo with respect to growth velocity. The overall incidence of adverse events was comparable between groups, and no significant changes in 10-hour overnight or 24-hour urinary free cortisol levels were noted between groups during the double-blind treatment period.

CONCLUSIONS. Ciclesonide demonstrated no detectable effect on childhood growth velocity, even at the highest dosage, which may ease concerns about systemic adverse events.

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Key Words: inhaled corticosteroids • ciclesonide • childhood growth • safety • hypothalamic-pituitary-adrenal axis

Abbreviations: ICS—inhaled corticosteroid • FDA—Food and Drug Administration • AE—adverse event • FEV₁—forced expiratory volume in 1 second • MDI—metered-dose inhaler • HFA—hydrofluoroalkane • CIC40—ciclesonide 40 µg/day • CIC160—ciclesonide 160 µg/day • CI—confidence interval • mITT—modified intention-to-treat • ANCOVA—analysis of covariance

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Accepted Jun 8, 2007.

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