The aim of the present study was to examine the efficacy of low-dose inhaled
budesonide (BUD) administered via Turbuhaler once or twice daily on symptoms, lung function and
bronchial hyperreactivity in children with mild
asthma. One hundred and sixty-three children (mean age 9.9 yrs, 56 females/107 males) with mild
asthma (forced expiratory volume in one second (FEV1) 103% of predicted, morning peak expiratory flow (PEF) 87%
pred, reversibility in FEV1 3%, fall in FEV1 after exercise 10.4% from pre-exercise value) and not previously treated with inhaled
steroids, were included in a double-blind, randomized, parallel-group study. After a two-week run-in period, the children received inhaled BUD 100 microg or 200 microg once daily in the morning, 100 microg twice daily or placebo for 12 weeks. Exercise and
methacholine challenges were performed before and at the end of treatment. After 12 weeks of
therapy, the fall in FEV1 after an exercise test was significantly less in all three BUD groups (43-5.1%) than in the placebo group (8.6%).
Bronchial hyperreactivity to
methacholine with the provocative dose causing a 20% fall in FEV1 decreased significantly in the BUD 100 microg twice-daily group compared with placebo (ratio at the end of treatment 156%). Changes in baseline lung function (FEV1 and PEF) were less marked than changes in bronchial responsiveness. In conclusion, low doses of inhaled
budesonide, given once or twice daily, provided protection against exercise-induced bronchoconstriction in children with mild
asthma and near normal lung function.