Ciclesonide Reduces the Need for Oral Steroid Use in Adult Patients With Severe, Persistent Asthma

Study objectivesOral corticosteroids (OCS) may be associated with systemic adverse events (AEs), which can be reduced by replacing OCS with inhaled corticosteroids (ICS). The potential of ciclesonide, a novel ICS, to reduce OCS use in patients with severe, persistent asthma was evaluated in this study.DesignA phase III, 12-week, international, multicenter, double-blind, placebo-controlled, parallel-group study.PatientsAdult and adolescent patients (≥ 12 years old; n = 141) with severe, persistent, oral steroid (prednisone)-dependent asthma.InterventionsPatients were randomized to receive ciclesonide (640 μg/d or 1,280 μg/d [ex-actuator]) bid or placebo for 12 weeks. Weekly evaluations determined eligibility for prednisone dose reduction based on predetermined criteria.Measurements and resultsThe prednisone dose was significantly reduced by 47% and 63% in the groups receiving ciclesonide, 640 μg/d, and ciclesonide, 1,280 μg/d, respectively, vs an increase of 4% in the placebo group (both p ≤ 0.0003) at week 12. By week 12, prednisone was discontinued by approximately 30% of patients in the ciclesonide-treated groups, vs 11% of patients in the placebo group (both p ≤ 0.04). FEV1 improved significantly at week 12 in the ciclesonide treatment groups vs placebo (p < 0.03). The occurrence of local and systemic AEs was comparable between all treatment groups.ConclusionStudy results suggest that ciclesonide significantly reduces the need for OCS in patients with severe, persistent asthma, while maintaining asthma control.