A PHASE III STUDY TO EVALUATE SAFETY AND EFFICACY OF FLUTICASONE/FORMOTEROL COMBINATION (FLUTIFORM<sup>®</sup> AEROSOL) IN LONG-TERM ADMINISTRATION (24 WEEKS) IN JAPANESE PEDIATRIC PATIENTS WITH BRONCHIAL ASTHMA

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  • Katsunuma Toshio
    Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine
  • Kamata Miho
    Clinical Development Center, Kyorin Pharmaceutical Co., Ltd.
  • Ishikawa Yasuyuki
    Clinical Development Center, Kyorin Pharmaceutical Co., Ltd.

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Other Title
  • 小児気管支喘息患者に対するフルチカゾン/ホルモテロール配合剤（フルティフォーム<sup>®</sup>エアゾール）の長期投与時（24週）における安全性及び有効性の検討
  • 小児気管支喘息患者に対するフルチカゾン/ホルモテロール配合剤(フルティフォームエアゾール)の長期投与時(24週)における安全性及び有効性の検討 : 第Ⅲ相長期投与試験
  • ショウニ キカンシ ゼンソク カンジャ ニ タイスル フルチカゾン/ホルモテロール ハイゴウザイ(フルティフォームエアゾール)ノ チョウキ トウヨジ(24シュウ)ニ オケル アンゼンセイ オヨビ ユウコウセイ ノ ケントウ : ダイ Ⅲ ソウ チョウキ トウヨ シケン
  • ―第III相長期投与試験―

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<p>Background: The combination drug of inhaled corticosteroid (ICS)/long-acting β2 agonist is being used as a long-term control medication for pediatric asthma patients for those who are poorly controlled by ICS alone. Long-term efficacy and safety of Fluticasone propionate/formoterol fumarate hydrate (FP/FM) was evaluated in pediatric patients with bronchial asthma.</p><p>Methods: Two inhales of FP/FM (50/5μg) at one time, twice daily were administered for 24 weeks to Japanese asthma patients aged 5 to ＜16 years who had asthma symptoms during the observation period while using the same dosage of ICS during a certain period of time. Adverse drug reactions, morning peak flow (mPEF) and asthma symptoms were evaluated 24 weeks after administration.</p><p>Results: FP/FM was administered to 53 subjects. 52 subjects completed the 24 week administration. The incidence of adverse drug reactions was 9.4% (5 of 53), and all of the adverse drug reactions were mild. The mPEF increased from the starting value and was maintained through the treatment period. The average change from baseline in the mPEF after 24 weeks of treatment was 21.39±2.93L/min (Least squares mean±standard error). Changes in asthma symptoms were similar to that of morning peak flow.</p><p>Conclusion: It was considered that FP/FM could be useful for long-term control of pediatric asthma.</p>

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