Long-term efficacy and safety of a budesonide dry powder inhaler in Japanese children with bronchial asthma : results of 54-week, open-label, multi-centre, study.

Abstract

[Objective] To determine the safety and efficacy of 54-week treatment with a budesonide dry powder inhaler (Turbuhaler^®) (BUD), compared with conventional therapy, in Japanese children with bronchial asthma.
[Method] Patients aged 5 to 15 years old; required treatment with inhaled corticosteroids; with mild persistent, moderate persistent, or severe persistent bronchial asthma; able to use the Turbuhaler^® appropriately, were included. They were treated with either inhaled BUD 100-800μg/day or conventional therapy (CONV : according to the Japanese Pediatric Guideline for the Treatment and Management of Asthma 2005) for 54 weeks (including 6 weeks in the preceding phase III comparative study). The primary endpoint was adverse events (AEs).
[Results] A total of 241 patients (BUD:121) were included in the safety/efficacy analysis. AEs occurred in 118 (97.5%) patients in the BUD group and in 116 (96.7%) patients in the CONV group. The AEs with high incidence (more than 25% in both groups) were upper respiratory tract infection, bronchitis, and gastroenteritis. Serious AEs occurred in 10 (8.3%) patients in the BUD group and in 11 (9.2%) patients in the CONV group. In the BUD group, improvements from baseline in pulmonary function parameters and asthma control parameters were maintained for 54 weeks. At the end of the treatment period, improvements in pulmonary function parameters and asthma control parameters were comparable in both groups.
[Conclusion] Treatment of 100-800μg/day of budesonide dry powder using the Turbuhaler^® for 54 weeks was well tolerated and effective in Japanese children aged 5 to 15 years with bronchial asthma requiring inhaled corticosteroids.