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
相关论文
共 42 条
[1]  
Adachi JD, 2001, INT J FERTIL WOMEN M, V46, P190
[2]   Current therapies for asthma - Promise and limitations [J].
Barnes, PJ .
CHEST, 1997, 111 (02) :S17-S26
[3]   New glucocorticosteroids with an improved therapeutic ratio? [J].
Belvisi, MG ;
Brown, TJ ;
Wicks, S ;
Foster, ML .
PULMONARY PHARMACOLOGY & THERAPEUTICS, 2001, 14 (03) :221-227
[4]  
BIBERGER C, 2003, AM J RESP CRIT CARE, V167, pA771
[5]   Asymptomatic airway hyperresponsiveness - A curiosity or an opportunity to prevent asthma? [J].
Boulet, LP .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2003, 167 (03) :371-378
[6]  
Bousquet J, 2000, CLIN EXP ALLERGY, V30, P2
[7]   HIGH-DOSE INHALED STEROID-THERAPY AND THE CORTISOL STRESS RESPONSE TO ACUTE SEVERE ASTHMA [J].
BROWN, PH ;
BLUNDELL, G ;
GREENING, AP ;
CROMPTON, GK .
RESPIRATORY MEDICINE, 1992, 86 (06) :495-497
[8]  
BUHL R, 2004, AM J RESP CRIT CARE, V169, pA91
[9]   Suppression of hypothalamic-pituitary-adrenal axis activity with inhaled flunisolide and fluticasone propionate in adult asthma patients [J].
Casale, TB ;
Nelson, HS ;
Stricker, WE ;
Raff, H ;
Newman, KB .
ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY, 2001, 87 (05) :379-385
[10]  
CHAPMAN KR, 2002, EUR RESP J S38, V20, pS373