Clinical efficacy of low-dose inhaled budesonide once or twice daily in children with mild asthma not previously treated with steroids

The aim of the present study was to examine the efficacy of low-dose inhale d budesonide (BUD) administered via Turbuhaler(R) once or twice daily on sy mptoms, lung function and bronchial hyperreactivity in children with mild a sthma, One hundred and sixty-three children (mean age 9.9 yrs, 56 females/107 male s) with mild asthma (forced expiratory volume in one second (FEV1) 103% of predicted, morning peak expiratory flow (PEF) 87% pred, reversibility in FE V1 3%,hll in FEV1 after exercise 10.4% from pre-exercise value) and not pre viously treated with inhaled steroids, were included in a double-blind, ran domized, parallel-group study. After a two-week run-in period, the children received inhaled BUD 100 mu g or 200 mu g once daily in the morning, 100 m u g twice daily or placebo for 12 weeks, Exercise and methacholine challeng es were performed before and at the end of treatment, After 12 weeks of therapy, the fall in FEV1 after an exercise test was sign ificantly less in all three BUD groups (4.3-5.1%) than in the placebo group (8.6%), Bronchial hyperreactivity to methacholine with the provocative dos e causing a 20% fall in FEV1 decreased significantly in the BUD 100 mu g tw ice-daily group compared with placebo (ratio at the end of treatment 156%), Changes in baseline lung function (FEV1 and PEF) were less marked than cha nges in bronchial responsiveness, In conclusion, low doses of inhaled budesonide, given once or twice daily, provided protection against exercise-induced bronchoconstriction in childre n with mild asthma and near normal lung function.