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Circadian Rhythm of Serum Cortisol after Repeated Inhalation of the New Topical Steroid Ciclesonide

Department of Clinical Pharmacology (A.W., D.H., M.Z., G.E.), Ernst Moritz Arndt University, Greifswald 17487, Germany; Byk Gulden Pharmaceuticals (W.T., V.W.S., T.B., W.W., A.D.), Konstanz 78467, Germany; and Oranienburger Pharmawerk (H.J.K.), Oranienburg 16515, Germany

Address all correspondence and requests for reprints to: Prof. Werner Siegmund, M.D., Institute of Pharmacology, University of Greifswald, Friedrich-Loeffler-Streat 23d, Greifswald D-17487, Germany. E-mail: . siegmuw{at}mail.uni-greifswald.de

Abstract

The new inhalative glucocorticoid ciclesonide which is activated in lung to a more potent metabolite was hypothesized to have low risk for systemic and local side-effects in man. Therefore, a placebo-controlled, randomized, double-blind, four-period, change-over equivalence study in 12 healthy male volunteers (age 21–28 yr, body weight 62–90 kg) was conducted to assess the influence of three dosage regimens (800 µg in the morning, 800 µg in the evening, 400 µg twice daily for 7 d, metered inhalers) on the circadian time serum cortisol rhythm.

Results: Serum cortisol showed the typical circadian rhythm. The geometric mean of the 24-h mesor (AUC_{(0–24 h)}/24 h) was 7.22 µg/dl for placebo, 6.75 µg/dl for the 800 µg ciclesonide morning dose, 7.08 µg/dl for the 800 µg evening dose, and 6.75 µg/dl for 400 µg ciclesonide inhaled twice daily. Because there was also no influence on cortisol amplitude and acrophase (time of maximum), the profiles after ciclesonide were equivalent to the placebo control. The small differences were considered not to be of clinical significance.

In conclusion, inhaled ciclesonide in daily doses of 800 µg for 7 d is without clinically relevant effects on the hypothalamic-pituitary-adrenal axis independent of the time of administration.

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