Oral Glucocorticosteroid-Sparing Effect of Budesonide Administered by Turbuhaler

A Double-blind, Placebo-Controlled Study in Adults With Moderate-to-Severe Chronic Asthma

¹ From the Department of Medicine, National Jewish Medical and Research Center, Denver
² From the the Allergy-Group, Inc, Cincinnati
³ From the Allergy Associates, Milwaukee
⁴ From the Allergy and Asthma Center of Albany Medical College, Albany, NY
⁵ From the Allergy Research Foundation, Los Angeles
⁶ From The Research Center Allergy Associates, Colorado Springs, Colo
⁷ From the UCLA School of Medicine, Los Angeles

Objective: To determine the ability of budesonide via an inhaler (Pulmicort Turbuhaler; Astra Draco AB) to replace oral glucocorticosteroids (GCSs) in adult subjects with moderate-to-severe asthma.

Design: Double-blind, randomized, and placebo-controlled study, with parallel groups.

Setting: Multicenter study in outpatient setting.

Participants: Eighty men and 79 women, aged 20 to 69 years, with moderate-to-severe asthma and a mean FEV₁ of 58.3% predicted normal. All subjects were receiving oral GCS treatment and 79% of subjects were also receiving inhaled beclomethasone dipropionate (BDP). The mean daily doses of prednisone at baseline, including converted dose of BDP, for the placebo, budesonide 400 µg, and budesonide 800 µg, respectively, were 19.7 mg, 19.5 mg, and 18.7 mg.

Measurements and interventions: After a 2-week baseline period, subjects entered a 20-week treatment period, during which the oral dose of prednisone was reduced by forced down-titration at 2-weekly intervals.

Results: Subjects receiving 400 µg or 800 µg bid of budesonide achieved a significantly greater reduction (82.9% and 79.0% respectively) in oral GCS dose compared with placebo-treated subjects (27%; p<0.001). Two thirds of the subjects receiving budesonide were able to achieve sustained oral corticosteroid cessation, compared with 8% in the placebo group. Additionally, both doses of budesonide resulted in significant improvement in results of pulmonary function 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 toward the normal range in the budesonide-treated groups compared with placebo-treated subjects.

Conclusion: Budesonide administered via Turbuhaler has a significant oral GCS-sparing capacity with maintained or improved asthma control in adult subjects with moderate-to-severe asthma.

Key Words: asthma • corticosteroids • inhaled • corticosteroids • oral

Submitted on June 18, 1997
Accepted on October 21, 1997

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