Ciclesonide is more effective than budesonide in the treatment of persistent asthma.

Abstract Background Ciclesonide is a lung-activated inhaled corticosteroid that provides effective control of persistent asthma. The objective of this study was to compare the efficacy and safety of once-daily ciclesonide versus once-daily budesonide in patients with asthma. Methods A total of 399 patients with asthma were randomised to receive once-daily ciclesonide 320 μg ex-actuator (equivalent to 400 μg ex-valve) or once-daily budesonide 400 μg for 12 weeks. The primary endpoint was forced expiratory volume in 1 s (FEV 1 ). Additional efficacy variables included forced vital capacity (FVC), peak expiratory flow (PEF), asthma symptoms, use of rescue medication and time to onset of effect. Adverse events were monitored throughout the study. Results Both ciclesonide and budesonide significantly increased FEV 1 from baseline (416 and 321 ml, respectively; p 0.0001 ). The increase in FEV 1 was significantly greater in ciclesonide-treated patients (95% confidence interval: 0.016–0.174; p = 0.019 versus budesonide). Similarly, ciclesonide and budesonide significantly improved FVC and PEF from baseline ( p 0.0001 ), and significantly greater increases occurred with ciclesonide ( p = 0.034 and 0.019 versus budesonide, respectively). Analysis of morning PEF revealed an earlier onset of action for ciclesonide versus budesonide; a significant improvement was seen by day 2 ( p = 0.039 versus baseline) with ciclesonide compared with day 7 for budesonide ( p = 0.047 versus baseline). Adverse events occurred with a similar incidence in both treatment groups. Neither treatment caused significant changes in urinary cortisol levels. Conclusion Once-daily ciclesonide was more effective than once-daily budesonide in improving FEV 1 , FVC and PEF. Ciclesonide also had an earlier onset of action than budesonide in patients with persistent asthma. Both ciclesonide and budesonide had good safety and tolerability profiles.