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

^* From the University of Cape Town (Dr. Bateman), Cape Town, South Africa; North Shore University Hospital (Dr. Karpel), Long Island, NY; Creighton University (Dr. Casale), Omaha, NE; and National Jewish Medical Research Center (Dr. Wenzel), Denver, CO; and Aventis Pharmaceuticals (Dr. Banerji), Bridgewater, NJ.

Correspondence to: Eric Bateman, MD, FRCP, University of Cape Town Lung Institute, PO Box 34560, Groote Schuur 7937, Cape Town, South Africa; e-mail: ebateman{at}uctgsh1.uct.ac.za

Abstract

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 [ex-actuator]) 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.

Key Words: ciclesonide • efficacy • inhaled corticosteroids • prednisone • pulmonary • safety • severe persistent asthma

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