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

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  • 6ヵ月〜4歳の日本人小児気管支喘息患者を対象としたブデソニド吸入用懸濁液のメッシュ式ネブライザーによる吸入の有効性及び安全性を検討する12週間投与オープン試験
  • 6カ月～4歳の日本人小児気管支喘息患者を対象としたブデソニド吸入用懸濁液のメッシュ式ネブライザーによる吸入の有効性及び安全性を検討する12週間投与オープン試験
  • 6カゲツ 4サイ ノ ニホンジン ショウニ キカンシ ゼンソク カンジャ オ タイショウ ト シタ ブデソニド キュウニュウヨウ ケンダクエキ ノ メッシュシキ ネブライザー ニ ヨル キュウニュウ ノ ユウコウセイ オヨビ アンゼンセイ オ ケントウスル 12シュウカン トウヨ オープン シケン

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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^[○!R] + LC Plus nebulizer^[○!R], Pari eMotion^[○!R] and Omron MicroAir NE-22U^[○!R]. BIS administered 0.25mg 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^[○!R] compared to other group. Plasma cortisol were decreased significantly at 4week in Omron MicroAir NE-22U^[○!R] 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 0.25mg qd is effective and safe in young asthmatic children.

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