Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma.

Background: Ciclesonide is a new inhaled corticosteroid (ICS). Information about its clinical efficacy and safety in relation to other ICS in children is needed for clinical positioning. Objective: This 12-week, randomized, double-blind, double-dummy, three-arm, parallel-group study compared the efficacy and safety of ciclesonide with fluticasone propionate in children with mainly moderate and severe persistent asthma. Methods: Seven hundred and forty-four patients (aged 6-11 years) were randomized to ciclesonide (80 or 160 mu g once daily) or fluticasone propionate (88 mu g twice daily), following a 2-4-week run-in. Efficacy measurements included forced expiratory flow in Is (FEV1), morning peak expiratory flow (PEF), asthma symptom scores, rescue medication use and quality of life. Systemic effect was assessed by 24-hour urine free cortisol adjusted for creatinine. Results: FEV1 and morning PEF increased from baseline in all groups (p < 0.0001). Ciclesonide 160 mu g was not inferior to fluticasone propionate 176 mu g for FEV1 (p = 0.0030, one-sided). In all groups, asthma symptom score sums and rescue medication use significantly improved (p < 0.0001). The percentages of asthma symptom-, rescue medication- and nocturnal awakening-free days were high, with no significant differences between treatments. Quality of life scores improved with all treatments (p < 0.0001). A significant dose-response occurred between low and higher doses of ciclesonide for exacerbations and asthma control definitions. The incidences of adverse events were comparable across treatments. Urine free cortisol levels decreased significantly with fluticasone propionate (p = 0.0103), but not with ciclesonide. Conclusion: once-daily ciclesonide has a clinical effect similar to that of fluticasone propionate, but does not suppress cortisol excretion, in children with moderate and severe asthma. (C) 2008 Elsevier Ltd. All rights reserved.