[Budesonide in the treatment of mild asthma. A placebo-controlled multicenter study in general practice]

Abstract

Fifty patients with mild asthma were randomized in a double-blind, parallel group design; 13 were protocol violators. Of the remaining 37, 20 patients were treated with budesonide, 17 with placebo. The Peak Expiratory Flow rate (PEF) was the main variable. In a diary, patients recorded PEF morning and evening, score of asthma symptoms and use of inhaled beta 2-agonist. Peak-flow and Goldberg's General Health Questionnaire were obtained at clinic visits. Parametric and non-parametric tests were used. All tests were two-tailed with a significance level of 0.05. The study proved that changes in the patients' PEF happened in the early phase of the treatment period. The increase in both morning and evening PEF and physical activity in the budesonide group were statistically significantly better than in the placebo group. There was no statistical difference between the two groups concerning the patients' general well-being as evaluated by Goldberg's General Health Questionnaire. No serious adverse events occurred. The conclusion is that patients with mild asthma had statistically significant effect on their morning and evening PEF and physical activity from treatment with a daily dose of 400 microgrammes budesonide given via Turbuhaler compared to treatment with placebo.