Ciclesonide reduces the need for oral steroid use in adult patients with severe, persistent asthma

被引:42
作者
Bateman, Eric
Karpel, Jill
Casale, Thomas
Wenzel, Sally
Banerji, Donald
机构
[1] Univ Cape Town, Lung Inst, ZA-7937 Cape Town, South Africa
[2] N Shore Univ Hosp, Long Isl City, NY USA
[3] Creighton Univ, Omaha, NE 68178 USA
[4] Natl Jewish Med & Res Ctr, Denver, CO USA
[5] Aventis Pharmaceut, Bridgewater, NJ USA
关键词
ciclesonide; efficacy; inhaled corticosteroids; prednisone; pulmonary; safety; severe persistent asthma;
D O I
10.1378/chest.129.5.1176
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
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 mu g/d or 1,280 mu g/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 mu g/d, and ciclesonide, 1,280 mu g/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 cielesonide-treated groups, vs: 11% of patients in the placebo group (both p <= 0.04). FEV1 improved significantly at week 12 in the cielesonide 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.
引用
收藏
页码:1176 / 1187
页数:12
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