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1 Dept of Pulmonology, University Hospital, Groningen, the Netherlands, 2 Centre Hospitalier, Perpignan, France, 3 Centre Médical Parot, Lyon, France, 4 Central Military Hospital, Heidelberglaan, Utrecht, the Netherlands, 5 Kunstlaan, Hasselt, Belgium and 6 Centre de Pneumologie, Saint-Quentin, France
CORRESPONDENCE: D.S. Postma, Dept of Pulmonology, University Hospital, Hanzeplein 1, NL-9713, Groningen, The Netherlands. Fax: 31 503619320
Keywords: Asthma, dosing time, inhaled steroids, once daily
Received: November 22, 2000
Accepted March 9, 2001
The study was supported by Byk Gulden Pharmaceuticals.
The study addressed the question whether the novel inhaled prodrug corticosteroid ciclesonide is equally effective when inhaled in the morning compared to the evening.
For this purpose a double-blind, randomized, parallel group study was initiated in which 209 asthmatic patients (forced expiratory volume in one second=50–90% predicted) inhaled either 200 µg ciclesonide in the morning or in the evening, for 8 weeks. Efficacy was assessed by means of spirometry as well as daily recordings of morning and evening peak expiratory flow (PEF), symptoms and use of rescue medication. The 24-h urinary cortisol excretion was measured to evaluate any effect on hypothalamic-pituitary-adrenol axis.
Ciclesonide significantly improved asthma control. Morning and evening administration was shown to be equally effective for the different spirometry variables, evening PEF, symptoms, use of rescue medication and number of asthma exacerbations. Regarding morning PEF, the improvements after evening dosing were more prominent and equivalence of morning and evening administration could not be demonstrated. No relevant influence on cortisol excretion was found.
Overall, the study indicates that ciclesonide can be given either in the morning or in the evening to meet the patients' preference and individual medical needs, although evening administration may lead to a more pronounced improvement in morning peak expiratory flow.
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