title: Circadian rhythm of serum cortisol after repeated inhalation of the new topical steroid ciclesonide.
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 microg in the morning, 800 microg in the evening, 400 microg 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 microg/dl for placebo, 6.75 microg/dl for the 800 microg ciclesonide morning dose, 7.08 microg/dl for the 800 microg evening dose, and 6.75 microg/dl for 400 microg 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 microg for 7 d is without clinically relevant effects on the hypothalamic-pituitary-adrenal axis independent of the time of administration.
authors: Department of Clinical Pharmacology, Ernst Moritz Arndt University, Greifswald 17487, Germany.
authors: Anita
authors: A
authors: Weinbrenner
authors: Dagny
authors: D
authors: Hüneke
authors: Michael
authors: M
authors: Zschiesche
authors: Georg
authors: G
authors: Engel
authors: Wolfgang
authors: W
authors: Timmer
authors: Volker W
authors: VW
authors: Steinijans
authors: Thomas
authors: T
authors: Bethke
authors: Wilhelm
authors: W
authors: Wurst
authors: Anton
authors: A
authors: Drollmann
authors: Hans Joachim
authors: HJ
authors: Kaatz
authors: Werner
authors: W
authors: Siegmund
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D002940:Circadian Rhythm; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D006854:Hydrocortisone / Q000097:blood*; D008297:Male; D011282:Pregnenediones / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology
chemical_list: D018927:Anti-Asthmatic Agents; D011282:Pregnenediones; C120481:ciclesonide; D006854:Hydrocortisone