Once-daily ciclesonide 80 or 320μg for 12 weeks is safe and effective in patients with persistent asthma

SummaryThe efficacy and safety of ciclesonide was assessed in this randomized, placebo-controlled study in patients with persistent asthma (randomized n=360) maintained on low to moderate doses of inhaled corticosteroids. Patients were randomized to receive ciclesonide 80 or 320μg (ex-actuator doses, equivalent to 100 and 400μg ex-valve, respectively) or placebo once daily in the morning via metered-dose inhaler for 12 weeks. Morning peak expiratory flow was maintained throughout the treatment period in patients treated with ciclesonide and decreased significantly in patients treated with placebo (P=0.0003). Ciclesonide (80 and 320μg) significantly increased forced expiratory volume in 1s from baseline (0.13 and 0.19L increases, respectively; P<0.01); improvements were superior versus placebo (P=0.0044 for 80μg ciclesonide; P