title: Assessment of the relative systemic potency of inhaled fluticasone and budesonide.
abstract: Studies using dry powder devices have suggested that fluticasone propionate (FP) has a greater systemic effect than budesonide (BUD). The aim of the present study was to investigate and compare the relative systemic potency of FP and BUD from their respective pressurized metered-dose inhalers (pMDIs). A placebo-controlled, open, randomized, cross-over study was conducted in 21 healthy male volunteers. Placebo, BUD (200, 400 and 1,000 micrograms b.i.d.) and FP (200, 375 and 1,000 micrograms b.i.d.) were inhaled for 4 days, with a wash-out period of at least 3 days between treatments. Blood samples for cortisol analysis were drawn during the last 24 h of each treatment period. Cortisol levels, measured as 24 h pooled plasma cortisol, were statistically significantly lower (p = 0.0001) for all dose levels during FP pMDI treatment (21, 39 and 84% suppression from placebo) than during BUD pMDI treatment (1, 3 and 27% suppression from placebo). The relative systemic potency FP:BUD was 3.7:1 (95% confidence interval (95% CI) 2.9-4.8)). The relative systemic potency based on the single 08:00 h samples was 5.2:1 (95% CI 3.0-9.3). In conclusion, in healthy male volunteers using pressurized metered-dose inhalers, fluticasone propionate was shown to have a stronger systemic effect than budesonide.
authors.affiliation: Astra Pharmaceutica BV, Zoetermeer, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Boorsma
authors.forename: N
authors.initials: N
authors.lastname: Andersson
authors.forename: P
authors.initials: P
authors.lastname: Larsson
authors.forename: A
authors.initials: A
authors.lastname: Ullman
mesh_terms: D000280:Administration, Inhalation; D000287:Administration, Topical; D000328:Adult; D000336:Aerosols; D000730:Androstadienes / Q000008:administration & dosage* / Q000494:pharmacology; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000494:pharmacology; D019819:Budesonide; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D000068298:Fluticasone; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D009330:Nebulizers and Vaporizers; D011282:Pregnenediones / Q000008:administration & dosage* / Q000494:pharmacology; D011863:Radioimmunoassay
chemical_list: D000336:Aerosols; D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D011282:Pregnenediones; D019819:Budesonide; D000068298:Fluticasone; D006854:Hydrocortisone