Science Links Japan | A Multi-center, Long-term, Open-label trial (Phase III) of Montelukast Fine Granules, a Cysteinyl Leukotriene Receptor 1 Antagonist, in Children Aged 1- to 5-year-old with Bronchial Asthma

A Multi-center, Long-term, Open-label trial (Phase III) of Montelukast Fine Granules, a Cysteinyl Leukotriene Receptor 1 Antagonist, in Children Aged 1- to 5-year-old with Bronchial Asthma

Accession number;05A0945095

Title;A Multi-center, Long-term, Open-label trial (Phase III) of Montelukast Fine Granules, a Cysteinyl Leukotriene Receptor 1 Antagonist, in Children Aged 1- to 5-year-old with Bronchial Asthma

Author; FURUSHO KENSHI (Kokuraarerugikurinikku) NISHIMA SANKEI (National Minami Fukuoka Chest Hospital, JPN) FURUKAWA SUSUMU (Yamaguchidai I Byoin Shonika) KONDO NAOMI (Gifudai I Byoin Shonika) IIKURA YOJI (Showadai Byoin Shonika) ODAJIMA YASUHIRA (Showadai Byoin Shonika) SAITO HIROHISA (Kokuritsuseiikuiryose Men'ekiarerugikenkyubu) AKAZAWA AKIRA (Kokuritsuseiikuiryose Shonikishinryoka) MASUDA KEI (Kokuritsuryoyoshomoriokabyoin Arerugika) WADA HIROYASU (Kokuritsuryoyoshomoriokabyoin Shonika) MIZUKI MASAMI (Kokuritsuryoyoshomoriokabyoin Rinshokenkyubu) MORIKAWA AKIHIRO (Gunmadai I Byoin Shonika) TOKUYAMA KEN'ICHI (Gunmadai I Byoin Shonika) MOCHIZUKI HIROYUKI (Gunmadai I Byoin Shonika) ARAKAWA KOICHI (Gunmadai I Byoin Shonika) KATO MASAHIKO (Gunmadai I Byoin Shonika) YOSHIHARA SHIGEMI (Dokkyo Univ. Sch. of Med., Hosp.) YAMADA HIROMI (Dokkyo Univ. Sch. of Med., Hosp.) ONO MIKA (Dokkyo Univ. Sch. of Med., Hosp.) ABE TOSHIO (Dokkyo Univ. Sch. of Med., Hosp.) AOYAGI MASAHIKO (Kokuritsuryoyoshoshimoshizubyoin Arerugika) SEKINE KUNIO (Shimoshizu National Hospital, JPN) WATANABE HIROKO (Shimoshizu National Hospital, JPN) KATSUNUMA TOSHIO (Tokyojikeikaiidai Byoin Shonika) FUKAWA MORIMITSU (Tokyojikeikaiidai Byoin Shonika) MIYATA ICHIRO (Tokyojikeikaiidai Byoin Shonika) KITABAYASHI SHINOBU (Showadai Byoin Shonika) MIURA KATSUSHI (Showadai Byoin Shonika) IMAI TAKANORI (Showadai Byoin Shonika) KAWAHARA HIDETOSHI (Kokuritsuseiikuiryose Shonikishinryoka) SHIBATA JUN (Kokuritsuseiikuiryose Shonikishinryoka) KAMIYA TARO (Kokuritsuseiikuiryose Shonikishinryoka) SHINOHARA SHIMEKAZU (Kokuritsuseiikuiryose Arerugika) SUDA YUKO (Kokuritsuseiikuiryose Arerugika) OYA YUKIHIRO (Kokuritsuseiikuiryose Arerugika) WATANABE HIROKO (Kokuritsuseiikuiryose Arerugika) NARITA MASAMI (Kokuritsuseiikuiryose Arerugika) MUKOYAMA TOKUKO (Doai Kinen Byoin) AOKI KUNITERU (Doai Kinen Byoin) NAKAZONO HIRONORI (Doai Kinen Byoin)

Journal Title;Journal of Clinical Therapeutics & Medicines

Journal Code:Y0906A

ISSN:0910-8211

VOL.21;NO.10;PAGE.1019-1029(2005)

Figure&Table&Reference;FIG.3, TBL.4, REF.11

Pub. Country;Japan

Language;Japanese

Abstract;Objective: We evaluated the safety and efficacy of montelukast administered as fine granules at 4mg once daily at bedtime for 8 weeks in 1- to 5-year-old children with bronchial asthma. In addition, we compared the plasma concentration of montelukast in 1- to 5-year-old children administered as fine granules at 4mg to in different age populations treated at the recommended clinical doses of montelukast in other age group. Method: Following 2 week run-in period without placebo, patients administered 4mg montelukast fine granules once daily at bedtime for 8 weeks. Results: The safety rate in the global safety was 98.6%. An adverse reaction was reported only in one of 72 patients evaluated for safety. The rate of patients judged moderate improvement or more by investigators was 89.4% (59/66 patients). The efficacy rate in the global improvement rating was shown at Week 2 and persistent through Week 8, the final week of the study. Body weight and age of the study subjects did not affect the safety and efficacy of montelukast in this study. The plasma concentrations of this study were generally similar to the mean plasma concentration-time profiles of healthy adult volunteers and pediatric patients aged 9- to 13-year-old following administration of 10mg film coated tablets and 5mg chewable tablets, respectively. Conclusions: The results indicate that treatment with montelukast 4mg fine granules once daily demonstrate good safety and efficacy profiles in children aged 1- to 5-year-old with mild to moderate asthma. Montelukast 4mg fine granule is considered to be a useful drug in the long-term management of asthma. (author abst.)

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