Once-daily budesonide in mild asthma.
Inhaled steroid therapy is the most important treatment in the management of chronic asthma and currently twice-daily administration is recommended in mild to moderate asthma. Compliance is often a problem in asymptomatic patients and may lead to reduced disease control. Our aim was to investigate whether budesonide 0.2 mg once daily administered via the Turbuhaler is as effective as 0.1 mg twice daily. A randomized, double-blind, parallel group study was carried out in which 76 adult patients with mild to moderate asthma (FEV1 86% of predicted) were allocated to budesonide once or twice daily. After a run-in period of 2 weeks on present inhaled steroid treatment (0.2-0.5 mg day-1) there was an 8 week treatment period, followed by a washout period in which patients received no steroid for 4 weeks unless a drop in morning peak flow of at least 20% occurred or the use of beta 2-agonists increased by 50%. Both treatment groups improved minimally in peak flow (1.7 and 4.31 min-1 in the once-daily and twice-daily groups respectively) but the differences between the two groups were not significant. Testing the reverse hypothesis revealed clinical equivalence. The 90% confidence interval of the difference in the change of peak flow from run-in was between +30 and -30 l min-1, the limits deemed to be clinically relevant. There were no differences in symptom scores, beta 2-agonist use or spirometry measurements between the two groups. In the washout period there was a significant deterioration in peak flow and symptoms. This study shows that 0.2 mg budesonide given once a day is as affective as 0.1 mg given twice daily in patients with mild to moderate asthma.