Similar efficacy of ciclesonide versus prednisolone to treat asthma worsening after steroid tapering
Received 7 October 2008; accepted 27 January 2009. published online 19 March 2009.
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 800μg twice daily (starting with 800μg hourly for 3h after randomization) or prednisolone 40mg 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 1s, 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 (800μg twice daily) has comparable efficacy to oral prednisolone (40mg 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.
aDepartment of Pulmonology, University Medical Center Groningen, Groningen, The Netherlands
bDepartment of Pulmonology, University Hospital of North Staffordshire, Newcastle, United Kingdom
cDepartment of Pulmonology, Hammersmith Hospital, London, United Kingdom
dPulmonary Research Institute, Hospital Grosshansdorf, Grosshansdorf, Germany
eDepartment of Pulmonology, Charité Universitätsmedizin, Berlin, Germany
Corresponding author. Department of Pulmonary Diseases, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. Tel.: +31 (0)50 3616161; fax: +31 (0)50 3619320.
f Present address: KLB Health Research, Lübeck, Germany.
ABSTRACT