Efficacy and safety evaluation of ciclesonide in mild-to-moderate persistent asthma previously treated with inhaled corticosteroids

Inhaled corticosteroids (ICSs) are recommended as first-line treatment for persistent asthma. This study was designed to evaluate the ability of ciclesonide (CIC) in subjects with stable asthma previously receiving another ICS or ICS/long-acting beta₂-agonist (LABA) to maintain asthma disease control. In this 12-week, multicenter, double-blind, parallel-group study, subjects aged ≥12 years with stable mild-to-moderate persistent asthma were switched at randomization from an ICS or ICS/LABA to CIC, 80 g twice daily (CIC80 b.i.d.; n = 149); CIC, 160 g once daily (CIC160 q.d.; n = 150); or placebo (n = 147). Change in forced expiratory volume in 1 second (FEV₁; primary end point), morning peak expiratory flow (PEF), rescue albuterol use, total asthma symptom score, nighttime awakenings, and safety were evaluated. FEV₁ improved from baseline to week 12 after CIC80 b.i.d. treatment (+0.07 L; p = 0.0232), and was maintained after CIC160 q.d. (+0.01 L; p = 0.6217). FEV₁ declined from baseline after placebo (−0.12 L; p < 0.0001) and significantly versus CIC treatments (p < 0.001). At week 12, morning PEF maintained baseline values after CIC80 b.i.d. (−4.43 L/minute; p = 0.1272) and decreased after CIC160 q.d. (−5.77 L/minute; p = 0.0490) and placebo (−12.82 L/minute; p < 0.0001); the difference between CIC80 b.i.d. and placebo was significant (p = 0.035). Baseline albuterol use, total daily asthma score, and nighttime awakenings were maintained after CIC treatments (p > 0.25), but increased after placebo (p ≤ 0.002); the difference between CIC80 b.i.d. and placebo was significant (p < 0.02). Incidence of adverse events was similar among treatment groups (range, 52.0‐57.9%). In this study, CIC80 b.i.d. maintained asthma control in subjects with stable mild-to-moderate asthma previously treated with ICS or ICS/LABA, was well tolerated, and, in general, was better than CIC160 q.d. in maintaining disease control.