Am. J. Respir. Crit. Care Med., Volume 162, Number 6, December 2000, 2053-2057

Therapeutic Ratio of Inhaled Corticosteroids in Adult Asthma
A Dose-Range Comparison between Fluticasone Propionate and Budesonide, Measuring Their Effect on Bronchial Hyperresponsiveness and Adrenal Cortex Function

LARS P. NIELSEN and RONALD DAHL

Department of Respiratory Diseases, Aarhus University Hospital, Aarhus, Denmark

Inhaled corticosteroids have become the mainstay treatment of bronchial asthma. However, simultaneous evaluations of efficacy and side effects are few. This study aimed to compare the relative effect of fluticasone propionate (FP) and budesonide (BUD) on bronchial responsiveness and endogenous cortisol secretion in adults with asthma. The study was double-blind and included 66 adults with asthma, who were randomized to FP (n = 33) or BUD (n = 33). Prestudy, all participants were clinically stable, using inhaled corticosteroids and hyperresponsive to methacholine. Eligible patients were randomized to three consecutive 2-wk periods with either FP 250 µg twice daily, FP 500 µg twice daily, and FP 1,000 µg twice daily, or BUD 400 µg twice daily, BUD 800 µg twice daily, and BUD 1,600 µg twice daily, delivered by Diskhaler and Turbuhaler, respectively. Before randomization and at the end of each treatment, bronchial methacholine PD₂₀, 24-h urinary cortisol excretion (24-h UC), plasma cortisol, serum osteocalcin, and blood eosinophils were determined. The relative PD₂₀ potency between FP and BUD was 2.51 (95% CI, 1.05-5.99; p < 0.05), while the relative 24-h UC potency was 0.60 (95% CI, 0.44-0.83; p < 0.01). The differential therapeutic ratio (FP/BUD) based on PD₂₀ potency and 24-h UC was 4.18 (95% CI, 1.16-15.03; p < 0.05). The difference in systemic potency was also seen for plasma cortisol, serum osteocalcin, and blood eosinophils. Therapeutic ratio over a wide dose range, determined by impact on bronchial responsiveness and endogenous corticosteroid production, seems to favor FP.

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