Ciclesonide Has No Effect on Growth in Prepubertal Children with Mild, Persistent Asthma, Irrespective of Age and Gender

RATIONALE: Growth velocity can differ according to age and gender in prepubertal children, which should be considered when assessing risk of growth suppression that may occur following inhaled corticosteroid (ICS) treatment. METHODS: A multinational, double-blind, placebo-controlled study assessed the effects of ciclesonide on growth in prepubertal children (males, 5-8.5 years; females, 5-7.5 years) with mild, persistent asthma. Following a 6-month run-in, 661 patients were randomized to ciclesonide 40μg (CIC40), ciclesonide 160μg (CIC160; both doses ex-actuator) or placebo once daily in the morning for 1 year. Height was measured (median of four stadiometer measurements) by trained personnel at each visit. Growth velocity was assessed using the linear regression estimate during double-blind treatment in children subgrouped according to age and gender (females <7 years; females >7 years; males <8 years; males >8 years). RESULTS: Mean linear growth velocities were comparable between ciclesonide and placebo groups for each stratum. Differences from placebo in mean linear growth velocities (95% confidence interval) were: 0.12cm/year (-0.29, 0.53) for CIC40 and -0.03cm/year (-0.44, 0.37) for CIC160 in females <7 years (placebo, 6.03cm/year); -0.31cm/year (-0.83, 0.21) for CIC40 and -0.59cm/year (-1.11, -0.06) for CIC160 in females >7 years (placebo, 5.94cm/year); -0.02cm/year (-0.29, 0.24) for CIC40 and -0.11cm/year (-0.39, 0.16) for CIC160 in males <8 years (placebo, 5.82cm/year); 0.08cm/year (-0.34, 0.49) for CIC40 and -0.19cm/year (-0.61, 0.23) for CIC160 in males >8 years (placebo, 5.16cm/year). CONCLUSIONS: Ciclesonide demonstrates no effect on growth in prepubertal children with asthma, irrespective of age and gender.