Comparable effects of inhaled fluticasone propionate and budesonide on theHPA-axis in adult asthmatic patients

This randomized, double-blind, double-dummy, multicentre cross-over study c ompared the effects on the hypothalamic-pituitary-adrenal (HPA) axis of flu ticasone propionate (750 mu g twice daily given via the Diskus(TM) and bude sonide (800 mu g twice daily given via the Turbuhaler(TM). Two treatment pe riods of 2 weeks each were preceded by a 2-week run-in period and separated by a 2-week washout period. During run-in and washout, patients received b eclomethasone dipropionate (BDP) or budesonide at a constant dose of 1500-1 600 mu g day(-1). Sixty patients aged 18-75 years with moderate to severe a sthma not fully controlled by treatment with 1500-1600 mu g day(-1) budeson ide or BDP entered run-in and 45 completed the study. HPA axis suppression was assessed by morning serum cortisol (area under the curve from 08.00 to 10.30 hours) and 12-h nocturnal urinary cortisol excretion, measured at the end of run-in (baseline 1), at the end of washout (baseline 2), and at the end of each treatment period. Neither budesonide nor fluticasone produced significant suppression of eith er parameter compared to baselines. Only a few patients had serum-cortisol and urinary cortisol values below the normal range, before and after treatm ent. This shows that the patients did not have adrenal suppression before e ntering the study. The ratio between the AUC serum cortisol measured after fluticasone treatment and after budesonide treatment was 0.99 (95% CI 0.92- 1.06), indicating equivalent effects on the HPA axis. This result was achie ved after having omitted two patients' results, due to their very sensitive reaction to budesonide. but not to fluticasone. Two exacerbations of acute asthma occurred during budesonide treatment and none during fluticasone tr eatment. Both treatments were well tolerated. In conclusion, budesonide 160 0 mu g day(-1) via Turbuhaler(TM) and fluticasone propionate 1500 mu g day( -1) via Diskus(TM) had no clinical effects on the HPA axis in patients with moderate to severe asthma.