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 mu g as a daily dose or fractionated in 400 mu g 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 mu g of inhaled budesonicle administered by MDI plus spacer was more effective in controlling symptoms and improving BHR than fractionating the dose to 400 mu g 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.