Similar efficacy of ciclesonide versus prednisolone to treat asthma worsening after steroid tapering

• Published in: Respiratory medicine 2009-08, Vol.103 (8), p.1216-1223
• Main Authors: van den Berge, M, Arshad, S.H, Ind, P.W, Magnussen, H, Hamelmann, E, Kanniess, F, Postma, D.S
• Format: Article
• Language: English
• Subjects: Anti-Asthmatic Agents - therapeutic use; Asthma; Asthma - drug therapy; Asthma - physiopathology; Biological and medical sciences; Bones, joints and connective tissue. Antiinflammatory agents; Bronchial Provocation Tests; Chronic obstructive pulmonary disease, asthma; Ciclesonide; Conflicts of interest; Dose-Response Relationship, Drug; Double-Blind Method; Drug therapy; Female; Forced Expiratory Volume - drug effects; Forced Expiratory Volume - physiology; Humans; Hydrocortisone - blood; Male; Medical sciences; Middle Aged; Peak Expiratory Flow Rate - drug effects; Peak Expiratory Flow Rate - physiology; Pharmacology. Drug treatments; Pneumology; Prednisolone; Prednisolone - therapeutic use; Pregnenediones - therapeutic use; Pulmonary/Respiratory; Respiratory therapy; Sputum
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2009.01.024

Summary Rationale Oral corticosteroids effectively treat asthma exacerbations but are associated with well-described side effects. Objective This study compared the efficacy and safety of a high dose of an inhaled corticosteroid with oral prednisolone in patients with worsening of their asthma after medication withdrawal. Methods Patients tapered off their inhaled corticosteroids until they reached predefined criteria of “worsening asthma”. Randomized patients ( n = 130) were treated double blind with either ciclesonide 800 μg twice daily (starting with 800 μg hourly for 3 h after randomization) or prednisolone 40 mg once daily for 2 weeks. Spirometry, daily asthma symptoms, morning and evening peak expiratory flow and blood parameters were assessed in all, methacholine challenge and inflammatory measures were determined in induced sputum in a subset of patients. Results Ciclesonide was as effective as prednisolone in improving forced expiratory flow in 1 s, morning peak expiratory flow and symptoms, the latter improving more rapidly with ciclesonide. No differences were found in methacholine responsiveness or inflammatory measures in sputum or blood. Ciclesonide caused significantly less reduction in morning plasma cortisol levels ( p < 0.0001). Conclusion This study shows that inhaled ciclesonide (800 μg twice daily) has comparable efficacy to oral prednisolone (40 mg once daily) to regain asthma control in patients with asthma worsening. The more rapid onset and smaller effect on cortisol suppression suggest a better safety profile of ciclesonide.