Efficacy of once-daily versus twice-daily administration of budesonide by Turbuhaler (R) in children with stable asthma

We evaluated the efficacy of once-daily versus twice-daily treatment with b udesonide, delivered by a Turbuhaler(R), in the management of children with stable asthma in a randomized, double-blind, parallel-group study involvin g 206 children (age 5-15 years). After a 2-week run-in period during which the children were maintained on their usual dose of budesonide (200 mu g or 400 mu g/day), patients were randomized to receive the same daily dose in either two daily administrations (morning and evening) or as a single dose in the morning over a period of 12 weeks. The primary efficacy variable was morning peak expiratory flow (PEF). The mean morning PEF during the run-in phase was 271 L/min in patients rand omized to once-daily treatment and 264 L/min in those randomized to twice-d aily treatment. The mean change from baseline to the last 2 weeks of the tr eatment period in the two groups was -0.3 L/min (95% confidence limits -6.6 to +6.0) and 2.5 L/min (-4.3 to +9.3). The estimated difference between th e groups was -2.8 L/min, with 90% confidence limits of -10.4 + 4.5; these w ere close to the limits regarded as indicative of equivalence (-10 to +10), and hence the difference was not regarded as clinically relevant. Similarl y, there were no significant differences between the groups in regard to se condary efficacy measures such as spirometric tests and symptom scores. Bot h treatments were well tolerated. We conclude that once-daily administration of budesonide by Turbuhaler(R) i s as effective as twice-daily treatment in the management of stable asthma in children treated with inhaled steroids at doses of 200-400 mu g/day. Ped iatr Pulmonol, 1999; 28:337-343, (C) 1999 Wiley-Liss, Inc.