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 blind crossover study in 19 children with moderate and severe asthma.


METHODS
A 2-week placebo treatment period (run-in) was followed by three 4-week treatment periods during which 100, 200, and 400 micrograms of budesonide were given per day in randomized order. Urinary cortisol excretion, lung functions, and protection against exercise-induced asthma were assessed at the end of run-in and each treatment period. Furthermore, morning and evening peak expiratory flow rates, day and night symptoms, and use of rescue beta 2-agonists were recorded throughout the study.


RESULTS
One hundred micrograms of budesonide per day markedly improved symptoms, morning and evening peak expiratory flow rates, and use of rescue beta 2-agonists (p < 0.01). No further improvement was seen in these parameters with increasing doses of budesonide. In contrast, a significant dose-response effect was found on lung functions measured at the hospital and fall in lung functions after exercise (p < 0.001); 200 micrograms was significantly better than 100 micrograms, and 400 micrograms was significantly better than 200 micrograms. About 53% of the maximum effect against exercise-induced asthma was achieved by the lowest budesonide dose (p < 0.001), and about 83% by the highest dose. No significant differences were seen in urinary cortisol excretion between run-in and the various budesonide doses.


CONCLUSIONS
Low doses of budesonide, which are not associated with any systemic side effects, have a marked antiasthma effect in children. Protection against exercise-induced asthma requires higher doses than achievement of symptom control.
Pedersen
S
S
Department of Paediatrics, Kolding Hospital, Denmark.
Hansen
O R
OR
D000293:Adolescent; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology / Q000652:urine; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019819:Budesonide; D002648:Child; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D008297:Male; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D011282:Pregnenediones / Q000008:administration & dosage* / Q000009:adverse effects; D014797:Vital Capacity / Q000187:drug effects
D001993:Bronchodilator Agents; D011282:Pregnenediones; D019819:Budesonide; D006854:Hydrocortisone