[Efficacy and safety of budesonide inhalation suspension nebulization by mesh nebulizer in Japanese infants and young children with bronchial asthma in 12-week, randomised, open study].

OBJECTIVE: This study evaluated the efficacy and safety of Budesonide Inhalation Suspension (BIS) nebulazation by mesh nebulizer in children ages 6 months to 4 years with moderate to severe persistent asthma. METHOD: This 12-week, randomized, open study involved 30 asthmatic children. They were randomized 3 different nebulizer groups, Pari TurboBoy +LC Plus nebulizer, Pari eMotion and Omron MicroAir NE-22U. BIS administered 0.25 mg once daily (qd). Efficacy was assessed by daily card. Safety was assessed by adverse event, plasma cortisol and growth. RESULT: Baseline concentrations of plasma cortisol were significantly high in the group of Omron MicroAir NE-22U compared to other group. Plasma cortisol were decreased significantly at 4 weeks in Omron MicroAir NE-22U compared with baseline, but those in no subjects decreased under normal range. Asthma symptoms were improved significantly from baseline to 12-week. CONCLUSION: This study demonstrate that usage of mesh nebulizer in BIS 0.25 mg qd is effective and safe in young asthmatic children.