Once-daily ciclesonide via metered-dose inhaler: Similar efficacy and safety with or without a spacer

Background: Inhaled corticosteroids (ICS) are recommended as first-line treatment for adults and children with persistent asthma. The Global Initiative for Asthma recommends that patients taking medium- or high-dose ICS delivered by metered-dose inhalers (MDIs) should use a spacer device. Methods: This randomized, open-label, 12-week, non-inferiority study compared the efficacy and safety of ciclesonide 160 mu g once daily delivered via hydrofluoroalkane-MDI alone (CIC160) or with a spacer (either an AeroChamber Plus [CIC160P] or an AeroChamber MAX [CIC160M]) in patients with persistent asthma. The primary efficacy variable was change in forced expiratory volume in 1 s (FEV1) from baseline to study end. Results: Significant improvements in FEV1 were observed from baseline to study end in each treatment group; least squares mean change from baseline ranged between 0.32 and 0.34L in the per-protocol (PP) analysis and similar results were observed for the intention-to-treat (ITT) analysis (p < 0.0001 for all). Non-inferiority of CIC160P and CIC160M to CIC160 was observed for both PP and ITT populations (p < 0.0001 [one-sided]). In all. groups, daily asthma symptom scores were reduced to 0 and significant reductions were observed in rescue medication use at study end (p < 0.0001 versus baseline for at[). Ciclesonide was welt tolerated in all groups and no cases of oral candidiasis were reported. Morning serum cortisol. levels significantly increased in all groups from baseline to study end (p <= 0.0389), with no significant between-treatment differences. Conclusion: In patients with persistent asthma, ciclesonide was shown to have similar efficacy and tolerability when administered via MDI alone or with a spacer. (C) 2009 Elsevier Ltd. All rights reserved.