Once versus twice daily budesonide metered-dose inhaler in children with mild to moderate asthma: effect on symptoms and bronchial responsiveness.

BACKGROUND Simplifying dosing regimens could improve both adherence and asthma-related morbidity. However, there is little information on the effectiveness of once-daily budesonide, administered through a metered dose inhaler (MDI) plus spacer, on asthma symptoms and pulmonary function in asthmatic children. METHODS The aim of this study was to compare the effect of once-daily versus twice-daily doses of inhaled budesonide on symptoms, lung function and bronchial hyperresponsiveness (BHR) in asthmatic children. This study was a randomized, single-blind, parallel clinical trial. Patients received budesonide from an MDI either 800 microg as a daily dose or fractionated in 400 microg twice a day for 12 weeks. Statistical analysis was performed using tests for independent and paired samples. RESULTS In both groups, asthma symptoms significantly decreased. However, the improvement in asthma symptoms, decrease in BHR and treatment adherence were significantly greater in the once-daily group than in the twice-daily group (p < 0.05). No significant differences were found between the two groups in spirometric parameters, morning peak expiratory flow or plasma cortisol values. CONCLUSIONS Once-daily administration of 800 microg of inhaled budesonide administered by MDI plus spacer was more effective in controlling symptoms and improving BHR than fractionating the dose to 400 microg twice daily. The differences observed in this study could have been due to the greater adherence to treatment in patients in the once-daily group.