ORAL GLUCOCORTICOSTEROID-SPARING EFFECT OF BUDESONIDE ADMINISTERED BYTURBUHALER - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN ADULTS WITH MODERATE-TO-SEVERE CHRONIC ASTHMA

Objective: To determine the ability of budesonide via an inhaler (Pulm icort Turbuhaler; Astra Draco AB) to replace oral glucocorticosteroids (GCSs) in adult subjects with moderate-to-severe asthma. Design: Doub le-blind, randomized, and placebo-controlled study, with parallel grou ps. Setting: Multicenter study in outpatient setting, Participants: Ei ghty men and 79 women, aged 20 to 69 years, with moderate-to-severe as thma and a mean FEV1 of 58.3% predicted normal. All subjects were rece iving oral GCS treatment and 79% of subjects were also receiving inhal ed beclomethasone dipropionate (BDP), The mean daily doses of predniso ne at baseline, including converted dose of BDP, for the placebo, bude sonide 400 mu g, and budesonide 800 mu g, respectively, were 19.7 mg, 19.5 mg, and 18.7 mg, Measurements and interventions: After a 2-week b aseline period, subjects entered a 20-week treatment period, during wh ich the oral dose of prednisone was reduced by forced down-titration a t 2-weekly intervals. Results: Subjects receiving 400 mu g or 800 mu g bid of budesonide achieved a significantly greater reduction (82.9% a nd 79.0% respectively) in oral GCS dose compared with placebo-treated subjects (27%; p<0.001), Two thirds of the subjects receiving budesoni de were able to achieve sustained oral corticosteroid cessation, compa red with 8% in the placebo group. Additionally, both doses of budesoni de resulted in significant improvement in results of pulmonary Functio n tests and asthma symptoms scores, and a significant decrease in the use of bronchodilator therapy. The mean plasma cortisol levels before and after adrenocorticotropic hormone stimulation increased most towar d the normal range in the budesonide-treated groups compared with plac ebo-treated subjects. Conclusion: Budesonide administered via Turbuhal er has a significant oral GCS-sparing capacity with maintained or impr oved asthma control in adult subjects with moderate-to-severe asthma.