Treatment of Chronic Childhood Asthma With Beclomethasone Dipropionate Aerosol: I. A Double-Blind Crossover Trial in Nonsteroid-Dependent Patients

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Abstract
Twenty-two children with chronic asthma requiring daily administration of bronchodilators but not steroids were administered 400 µg of beclomethasone dipropionate aerosol (BDA) or a placebo (vehicle) in a double-blind crossover study. The experimental design consisted of four study periods (four weeks each): (1) baseline, (2) BDA or placebo treatment, (3) washout, (4) BDA or placebo treatment. Evaluation of effectiveness was assessed by daily symptom and medication scores, Wright Peak Flow (WPF) measurements three times each day, and weekly spirometry. Pituitary-adrenal function was evaluated by diurnal measurement of cortisol level, intravenous (IV) metyrapone tests, and IV adrenocorticotropic hormone responses. Quantitative throat cultures for Candida were taken monthly. Twenty-one of 22 patients correctly identified BDA. The mean weekly symptom score was 76.5 ± 10.8 (mean ± SE) during placebo compared to 21.3 ± 5.3 during BDA therapy (P < .005). The number of attacks per week was 7.1 ± 1.4 in those receiving placebo and 1.6 ± 0.6 in those receiving BDA (P < .005). Mean medication score was 39.6 ± 3.6 during placebo and 21.6 ± 1.3 during BDA therapy (P < .005). Mean weekly average WPF measurements increased 33% with BDA therapy compared to placebo. Eighty percent of patients showed an increase in forced expiratory volume in one second and in maximum midexpiratory flow rate during BDA therapy. All throat cultures were negative. No pituitary-adrenal function suppression was noted in any of the parameters studied. BDA was shown to be highly effective in controlling asthma and produced no adverse effects.

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