E. Derom et al., Systemic effects of inhaled fluticasone propionate and budesonide in adultpatients with asthma, AM J R CRIT, 160(1), 1999, pp. 157-161
We assessed the systemic effects of budesonide (BUD) and fluticasone propio
nate (FP) in 23 patients with asthma, using a double-blind, placebo-control
led, double-dummy, and cross-over design. The following five treatments wer
e given in a randomized order for 1 wk with a washout period in between of
2 wk: (7) placebo; (2) FP, 200 mu g twice a day, inhaled from a Diskhaler;
(3) FP, 1,000 mu g twice a day, inhaled from a Diskhaler; (4) BUD, 200 mu g
twice a day, inhaled from a Turbuhaler; and (5) BUD, 800 mu g twice a day,
inhaled from a Turbuhaler. The primary variable was the area under the cur
ve of serum cortisol versus time (AUC(0-20)), derived from serum samples ta
ken every 2 h over a 20-h period following the last evening dose at 10:00 P
.M. The lower doses of BUD and FLU did not cause any adrenal suppression. C
ompared with placebo, however, FP (1,000 mu g, twice daily and BUD (800 mu
g, twice daily) decreased the AUC(0-20) by 34 and 16%, respectively. Flutic
asone (1,000 mu g, twice,daily) was more suppressive than BUD (800 mu g, tw
ice daily) (p = 0.0006). The FEV1, measured the morning after the last inha
lation, was significantly higher after the active treatments, compared with
placebo (p < 0.02), but did not differ between all active treatments. We c
onclude that high doses of BUD and FP tin particular the latter), inhaled v
ia their respective dry powder inhalers for 1 wk, result in a measurable sy
stemic activity in patients with asthma.