Study objectives: Oral 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. Design: A phase III, 12-week, international, multicenter, double-blind, placebo-controlled, parallel-group study. Patients: Adult and adolescent patients (≥ 12 years old; n = 141) with severe, persistent, oral steroid (prednisone)-dependent asthma. Interventions: Patients were randomized to receive ciclesonide (640 μg/d or 1,280 μg/d [exactuator]) bid or placebo for 12 weeks. Weekly evaluations determined eligibility for prednisone dose reduction based on predetermined criteria. Measurements and results: The 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. Conclusion: Study results suggest that ciclesonide significantly reduces the need for OCS in patients with severe, persistent asthma, while maintaining asthma control.
