M. Boorsma et al., ASSESSMENT OF THE RELATIVE SYSTEMIC POTENCY OF INHALED FLUTICASONE AND BUDESONIDE, The European respiratory journal, 9(7), 1996, pp. 1427-1432
Studies using dry powder devices have suggested that fluticasone propi
onate (FP) has a greater systemic effect than budesonide (BUD). The ai
m of the present study was to investigate and compare the relative sys
temic potency of FP and BUD from their respective pressurized metered-
dose inhalers (pMDIs). A placebo-controlled, open, randomized, cross-o
ver study was conducted in 21 healthy male volunteers, Placebo, BUD (2
00, 400 and 1,000 mu g b.i.d.) and FP (200, 375 and 1,000 mu g b.i.d.)
were inhaled for 4 days, with a wash-out period of at least 3 days be
tween treatments, Blood samples for cortisol analysis were drawn durin
g 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 system
ic 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 meter
ed-dose inhalers, fluticasone propionate was shown to have a stronger
systemic effect than budesonide.