Abstract
[Objective] To evaluate the efficacy and safety of a budesonide dry powder inhaler (Turbuhaler®) (BUD) in Japanese children with bronchial asthma, using fluticasone propionate dry powder inhaler (Diskus®) (FP) as the reference.
[Method] Patients were included if they were 5 to 15 years old; required treatment with inhaled corticosteroids; their morning mean peak expiratory flow % of predicted normal (%mPEF) was less than 90%; had mild persistent, moderate persistent or severe persistent bronchial asthma, and could use the Turbuhaler® and Diskus® appropriately. They were prescribed 100 or 200 μg of BUD twice a day, or 50 or 100 μg of FP twice a day for 6 weeks. The primary endpoint for efficacy was the change in %mPEF at the end of Week 6 from the baseline. (ClinicalTrials.gov identifier: NCT00504062)
[Results] Two hundred and forty-four patients treated with the investigational products (120 in the BUD group) were included in the analysis. The mean change in %mPEF was 8.0% in the BUD group and 7.0% in the FP group, showing a significant improvement in both groups. The estimated intergroup difference in the change in %mPEF was 0.95% (95% confidence interval: -2.77 to 4.67), showing no significant difference. The BUD group showed significant improvement (compared with baseline) in most secondary endpoints at Week 6. Adverse events occurred in 61 patients (51%) in the BUD group and in 60 (48%) in the FP group; the adverse events with high incidence were upper respiratory tract infection, influenza and gastroenteritis. Regarding adverse drug reactions, mild dysphonia occurred in 1 patient in the BUD group. There was no obvious difference in the number of patients showing serious adverse events or the number of patients who discontinued due to adverse events between the groups. No safety concerns were suggested from the changes seen in the other safety items measured.
[Conclusion] Administration of 100 and 200 μg of budesonide dry powder inhaler twice-daily for 6 weeks was effective and well tolerated in Japanese children with bronchial asthma aged 5 to 15 years requiring inhaled corticosteroids.
