Comparative efficacy of once-daily ciclesonide and budesonide in the treatment of persistent asthma
ee front matter & 2005 med.2005.11.030 ng author. Tel.: +1 418 ess: lpboulet@med.ulav Summary Background: The aim of this study was to compare the efficacy and safety of oncedaily 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 mg (ex-mouthpiece, equivalent to 400–800 mg; Turbohaler) daily entered a 2-week baseline, and then a 2to 4-week pretreatment period (budesonide 1280 mg/day; exmouthpiece, equivalent to 1600 mg/day). Patients with an increase in forced expiratory volume in 1 s (FEV1) of X7% or X0.15 L were randomised to ciclesonide 320 mg (ex-actuator, equivalent to 400 mg ex-valve) via a hydrofluoroalkane-metered dose inhaler (HFA-MDI) without a spacer or budesonide 320 mg 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 1⁄4 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 1⁄4 0.017). Rescue medication use decreased significantly only for ciclesonide patients (P 1⁄4 0.009). Frequency of adverse events was low in both groups.