Systemic effects of inhaled fluticasone propionate and budesonide in adult patients with asthma

We assessed the systemic effects of budesonide (BUD) and fluticasone propionate (FP) in 23 patients with asthma, using a double-blind, placebo-controlled, double-dummy, and cross-over design. The following five treatments were 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 curve of serum cortisol versus time (AUC(0-20)), derived from serum samples taken 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. Compared 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. Fluticasone (1,000 mu g, twice,daily) was more suppressive than BUD (800 mu g, twice daily) (p = 0.0006). The FEV1, measured the morning after the last inhalation, was significantly higher after the active treatments, compared with placebo (p < 0.02), but did not differ between all active treatments. We conclude that high doses of BUD and FP tin particular the latter), inhaled via their respective dry powder inhalers for 1 wk, result in a measurable systemic activity in patients with asthma.