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

Abstract

Children (22) with chronic asthma requiring daily administration of bronchodilators but not steroids were administered 400 .mu.g of beclomethasone dipropionate aerosol (BDA) or a placebo (vehicle) in a double-blind crossover study. The experimental design consisted of 4 study periods (4 wk 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 3 times each day, and weekly spirometry. Pituitary-adrenal function was evaluated by diurnal measurement of cortisol level, i.v. metyrapone tests, and i.v. ACTH 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% iwht BDA therapy compared to placebo. Eighty percent of patients showed an increase in forced expiratory volume in 1 s and in maximum midexpiratory flow rate during BDA therapy. All throat cultures were noted in any of the parameters studied. BDA was shown to be highly effective in controlling asthma and produced no adverse effects.