Systemic Effect Comparisons of Six Inhaled Corticosteroid Preparations Academic Article uri icon

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  • The goal of this study was to establish a reliable method to evaluate systemic bioavailability and to determine equisystemic effects (microgram dose producing equal systemic cortisol suppression) of inhaled corticosteroids (ICS). Steroid naive asthma subjects (n = 156) were enrolled at six centers. A 1-week doubling dose design was used for each of six ICS and matched placebos for a total of four doses. Systemic effect was evaluated by hourly plasma cortisol concentrations (8 P.M. to 8 A.M.), 12- and 24-hour urine cortisol concentrations, and a morning blood osteocalcin. The area under the concentration-time curve for hourly cortisol concentrations was the best outcome variable to assess systemic effect. For the six ICS and matching placebos (beclomethasone-chlorofluorocarbon [CFC], budesonide dry powder inhaler [DPI], fluticasone DPI, fluticasone-CFC metered dose inhaler [MDI], flunisolide-CFC, and triamcinolone-CFC), only the placebo group and fluticasone DPI did not demonstrate a significant dose-response effect. Thus microgram comparison of all ICS could only be performed at a 10% cortisol suppression: flunisolide-CFC - 936; triamcinolone-CFC - 787; beclomethasone-CFC - 548; fluticasone DPI - 445; budesonide DPI - 268; fluticasone-CFC MDI - 111. This study represents the first step in evaluation of ICS efficacy based on equisystemic (cortisol suppression) effects of a given ICS, rather than doses judged arbitrarily to be comparable on a microgram basis.


  • Martin, Richard J
  • Szefler, Stanley J
  • Chinchilli, Vernon M
  • Kraft, Monica
  • Dolovich, Myrna
  • Boushey, Homer A
  • Cherniack, Reuben M
  • Craig, Timothy J
  • Drazen, Jeffrey M
  • Fagan, Joanne K
  • Fahy, John V
  • Fish, James E
  • Ford, Jean G
  • Israel, Elliott
  • Kunselman, Susan J
  • Lazarus, Stephen C
  • Lemanske, Robert F
  • Peters, Stephen P
  • Sorkness, Christine A

publication date

  • May 15, 2002

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