Comparative efficacy of once-daily ciclesonide and budesonide in the treatment of persistent asthma

Background: The aim of this study was to compare the efficacy and safety of once-daily ciclesonide, a new-generation, on-site-activated, inhaled corticosteroid, with once-daily budesonide in persistent asthma. Methods: Eligible patients requiring budesonide or equivalent 320-640 mu g (ex-mouthpiece, equivalent to 400-800 mu g; Turbohaler (TM)) daily entered a 2-week baseline, and then a 2- to 4-week pretreatment period (budesonide 1280 mu g/day; ex-mouthpiece, equivalent to 1600 mu g/day). Patients with an increase in forced expiratory volume in 1s (FEV1) of >= 7% or >= 0.15 L were randomised to ciclesonide 320 mu g (ex-actuator, equivalent to 400 mu g ex-valve) via a hydrofluoroalkane-metered dose inhaler (HFA-MDI) without a spacer or budesonide 320 mu g once daily in the morning for 12 weeks. Change in FEV1 was the primary endpoint. Results: In all, 359 patients were randomised. The FEV1 and forced vital capacity (FVC) decreased by 0.18 and 0.12 L, respectively, in the ciclesonide group, and by 0.23 and 0.21 L in the budesonide group. For FEV1, ciclesonide was noninferior and numerically superior to budesonide. For FVC, ciclesonide was statistically superior to budesonide (P = 0.010). Asthma symptom scores were comparable; the median percentage of symptom-free days was significantly higher for ciclesonide (43.6%) versus budesonide (25.8%) (P = 0.017). Rescue medication use decreased significantly only for ciclesonide patients (P = 0.009). Frequency of adverse events was low in both groups. Conclusion: Ciclesonide 320 mu g once daily by HFA-MDI without a spacer was at least as effective as budesonide 320 mu g once daily in persistent asthma. (c) 2005 Elsevier Ltd. All rights reserved.