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An assessment of the systemic activity of single doses of inhaled fluticasone propionate in healthy volunteers [see comments]
Author(s) -
Grahnen A,
Eckernas SA,
Brundin RM,
LingAndersson A
Publication year - 1994
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.1994.tb04393.x
Subject(s) - fluticasone propionate , placebo , fluticasone , budesonide , medicine , corticosteroid , dosing , area under the curve , hydrocortisone , pharmacokinetics , endocrinology , glucocorticoid , pharmacology , alternative medicine , pathology
1. The systemic effects of inhaled fluticasone propionate (FP), administered via Diskhaler, on the hypothalamo‐pituitary‐adrenal (HPA) axis were assessed primarily by measuring plasma cortisol at frequent intervals for 20 h after drug administration. 2. FP showed a dose‐ related suppression of plasma cortisol measured as area under the plasma cortisol vs time curve (AUC 0‐20). The cortisol suppression (expressed as % fall from placebo) was 8, 19, and 28% for single doses of 250 micrograms FP, 500 micrograms FP and 1000 micrograms FP, respectively. A single dose of budesonide, 800 micrograms (via Turbuhaler), resulted in a 16% cortisol suppression. The cortisol suppression for all three single doses of FP, and for the single dose of budesonide, was statistically significantly different from placebo. 3. Repeated dosing of FP (1000 micrograms twice daily for 3.5 days) resulted in a more marked plasma cortisol suppression; a fall of 65% from placebo (AUC FP 1000 mg twice daily vs AUC placebo, P < 0.001). 4. In a well‐controlled study in healthy volunteers, inhaled FP, in therapeutic doses, was shown to exhibit systemic effects which appear to be more pronounced after repeated dosing.