BUDESONIDE TREATMENT OF MODERATE AND SEVERE ASTHMA IN CHILDREN - A DOSE-RESPONSE STUDY

Objective: The purpose of the study was to evaluate the dose-response relationships of the inhaled corticosteroid budesonide in a double bli nd crossover study in 19 children with moderate and severe asthma. Met hods: A 2-week placebo treatment period (run-in) was followed by three 4-week treatment periods during which 100, 200, and 400 mu g of budes onide were given per day in randomized order. Urinary cortisol excreti on, lung functions, and protection against exercise-induced asthma wer e assessed at the end of run-in and each treatment period. Furthermore , morning and evening peak expiratory pow rates, day and night symptom s, and use of rescue beta(2)-agonists were recorded throughout the stu dy. Results: One hundred micrograms of budesonide per day markedly imp roved symptoms, morning and evening peak expiratory pow rates, and use of rescue beta(2)-agonists (p < 0.01). No further improvement was see n in these parameters with increasing doses of budesonide. In contrast , a significant dose-response effect was found on lung functions measu red at the hospital and fall in lung functions after exercise (p < 0.0 01); 200 mu g was significantly better than 100 mu g, and 400 mu g was significantly better than 200 mu g. About 53% of the maximum effect a gainst exercise-induced asthma was achieved by the lowest budesonide d ose (p < 0.001), and about 83% by the highest dose. No significant dif ferences were seen in urinary cortisol excretion between run-in and th e various budesonide doses. Conclusions: Low doses of budesonide, whic h are not associated with any systemic side effects, have a marked ant iasthma effect in children. Protection against exercise-induced asthma requires higher doses than achievement of symptom control.