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Ciclesonide Shows Good Safety and Efficacy in Children With Asthma: Presented at EAACI By Norra MacReady VIENNA, AUSTRIA -- June 14, 2006 -- Ciclesonide is safer and as effective as budesonide at improving lung function in children with persistent asthma, according to a study presented at the 25th Congress of the European Academy of Allergology and Clinical Immunology (EAACI). Like budesonide (Pulmicort), ciclesonide (Alvesco) is an inhaled corticosteroid. It has been approved in Europe for treatment of adults and has an approvable designation from the Food and Drug Administration in the United States. Investigators led by Andrea von Berg, MD, Marienhospital Wesel, Wesel, Germany, conducted this randomized, double-blind, double-dummy, two-arm group study to compare ciclesonide (n = 340) and budesonide (n = 173). Patients ranged in age from 6 to 11 years, with a median of 9 years for both groups. More than 90% of the subjects had moderate to severe asthma. Children in the ciclesonide group had a mean predicted forced expiratory volume in 1 second (FEV1) of 1.53 L, not significantly different from the mean of 1.56 L for the budesonide group. There was also no significant difference in mean morning peak expiratory flow (PEF) rates (199 L/min for ciclesonide and 204 L/min for budesonide). After a 2-week baseline period using only rescue medication, patients took a single dose of 160 mcg of ciclesonide or 400 mcg of budesonide every evening for 12 weeks. By 12 weeks, both groups had improved significantly over baseline; there were no significant differences between groups. The mean FEV1 had improved by 220 mL/min among patients taking ciclesonide and by 253 mL/min among patients taking budesonide (P < .0001 compared to baseline for both groups). Mean morning PEF increased by 22.5 L/min with ciclesonide and by 26.5 L/min with budesonide (P < .0001 compared to baseline for both groups). Both groups also experienced a significant increase in height (P < .0001 over baseline). However, there was a greater change in height among children using ciclesonide than those using budesonide (1.2 cm vs. 0.7 cm; P = .0025). Ciclesonide also had less of an effect on the hypothalamic-pituitary-adrenal axis, as reflected in changes in 24-hour urinary free cortisol levels. There was a decrease in this marker of 2 mol/mmol creatinine, and a decrease of 5 mol/mmol creatinine for children using budesonide (P = .0001). These findings suggest that ciclesonide has a similar impact to budesonide on lung function and a more favorable safety profile than budesonide in children with asthma, the investigators concluded. [Presentation title: Efficacy and Safety of Ciclesonide 160 mcg Once Daily in Pediatric Asthma Patients - A Comparative Study with Budesonide 400 mcg Once Daily. Poster 473] E-mail this page to a friend or colleague! To print, use this version