Ciclesonide, Administered Once Daily, has No Effect on Skeletal Maturity in Prepubertal Children with Mild, Persistent Asthma

Abstract

RATIONALE: Final adult height is dependent on both growth velocity and skeletal maturity. Skeletal age was examined to assess the effects of long-term treatment with the novel inhaled corticosteroid ciclesonide on childhood growth.METHODS: In this multinational, double-blind, placebo-controlled growth study, 661 prepubertal children (males, 5-8.5 years; females, 5-7.5 years) were randomized to receive ciclesonide 40μg (CIC40), ciclesonide 160μg (CIC160; both doses ex-actuator) or placebo once daily in the morning for 1 year. Bone age range was centrally recorded in a blinded manner at baseline and at the end of double-blind treatment using wrist X-rays graded according to the Greulich and Pyle radiographic atlas. If chronological age fell within the limits of bone age range (lower limit -1, upper limit +1), a normal chronological to extended bone age ratio was reported; high ratios are indicative of growth retardation.RESULTS: Shifts in chronologic age relative to bone age from baseline to end of double-blind treatment were comparable among treatment groups. For the majority of patients in all treatment groups, chronologic age to bone age ratio was normal on study entry and at end of double-blind treatment (CIC40, 62.2%; CIC160, 68.0%; placebo, 68.9%). Only 17 patients (CIC40, 4.3%; CIC160, 1.1%; placebo, 4.0%) shifted from normal to high ratios, with the fewest reports occurring in the CIC160 group. No patients shifted from low to high ratios.CONCLUSIONS: The findings from this study showed that the novel inhaled corticosteroid ciclesonide has no effect on skeletal maturity in prepubertal children with asthma. RATIONALE: Final adult height is dependent on both growth velocity and skeletal maturity. Skeletal age was examined to assess the effects of long-term treatment with the novel inhaled corticosteroid ciclesonide on childhood growth. METHODS: In this multinational, double-blind, placebo-controlled growth study, 661 prepubertal children (males, 5-8.5 years; females, 5-7.5 years) were randomized to receive ciclesonide 40μg (CIC40), ciclesonide 160μg (CIC160; both doses ex-actuator) or placebo once daily in the morning for 1 year. Bone age range was centrally recorded in a blinded manner at baseline and at the end of double-blind treatment using wrist X-rays graded according to the Greulich and Pyle radiographic atlas. If chronological age fell within the limits of bone age range (lower limit -1, upper limit +1), a normal chronological to extended bone age ratio was reported; high ratios are indicative of growth retardation. RESULTS: Shifts in chronologic age relative to bone age from baseline to end of double-blind treatment were comparable among treatment groups. For the majority of patients in all treatment groups, chronologic age to bone age ratio was normal on study entry and at end of double-blind treatment (CIC40, 62.2%; CIC160, 68.0%; placebo, 68.9%). Only 17 patients (CIC40, 4.3%; CIC160, 1.1%; placebo, 4.0%) shifted from normal to high ratios, with the fewest reports occurring in the CIC160 group. No patients shifted from low to high ratios. CONCLUSIONS: The findings from this study showed that the novel inhaled corticosteroid ciclesonide has no effect on skeletal maturity in prepubertal children with asthma.