Science Links Japan | A Non-Controlled Phase II Open-label Study of Montelukast Chewable Tablets, a Cysteinyl Leukotriene Receptor 1 Antagonist, in Children Aged 2-to 5-year-old with Bronchial Asthma,-Evaluation of the Efficacy, Safety and Plasma Concentration Profile-

A Non-Controlled Phase II Open-label Study of Montelukast Chewable Tablets, a Cysteinyl Leukotriene Receptor 1 Antagonist, in Children Aged 2-to 5-year-old with Bronchial Asthma,-Evaluation of the Efficacy, Safety and Plasma Concentration Profile-

Accession number;05A0945093

Title;A Non-Controlled Phase II Open-label Study of Montelukast Chewable Tablets, a Cysteinyl Leukotriene Receptor 1 Antagonist, in Children Aged 2-to 5-year-old with Bronchial Asthma,-Evaluation of the Efficacy, Safety and Plasma Concentration Profile-

Author; FURUSHO KENSHI (Kokuraarerugikurinikku) NISHIMA SANKEI (National Minami Fukuoka Chest Hospital, JPN) FURUKAWA SUSUMU (Yamaguchidai I Byoin Shonika) KONDO NAOMI (Gifudai I Byoin Shonika) SHINOMIYA KEISUKE (Kokuritsuhimejibyoin Shonika) IIKURA YOJI (Showadai Byoin Shonika) SAITO HIROHISA (Kokuritsushonibyoin Men'ekiarerugikenkyubu) AKAZAWA AKIRA (National Children's Hospital, JPN) AKASAKA TOORU (Kokuritsuryoyoshomoriokabyoin Shonika) WADA HIROYASU (Kokuritsuryoyoshomoriokabyoin Shonika) ICHITO NAHOKO (Kokuritsuryoyoshomoriokabyoin Shonika) MASUDA KEI (Kokuritsuryoyoshomoriokabyoin Shonika) 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) SAGA REIKO (Gunmadai I Byoin Shonika) NAGAYAMA YOKO (Chiba Children's Hospital, JPN) TOBA TSUYOSHI (Chiba Children's Hospital, JPN) TSUBAKI TOSHIKAZU (Chiba Children's Hospital, JPN) AOYAGI MASAHIKO (Shimoshizu National Hospital, JPN) SEKINE KUNIO (Shimoshizu National Hospital, JPN) WATANABE HIROKO (Shimoshizu National Hospital, JPN) ODAJIMA YASUHIRA (Showadai Byoin Shonika) MIURA KATSUSHI (Showadai Byoin Shonika) TAKAMURA MAYUMI (Showadai Byoin Shonika) KATSUNUMA TOSHIO (National Children's Hospital, JPN) OYA YUKIHIRO (National Children's Hospital, JPN) SUDA YUKO (National Children's Hospital, JPN) KAWAHARA HIDETOSHI (National Children's Hospital, JPN) MORISAWA YUTAKA (National Children's Hospital, JPN) MUKOYAMA TOKUKO (Doai Kinen Byoin) IDE FUMIHITO (Doai Kinen Byoin) KURIHARA KAZUYUKI (Kanagawa Children's Medical Center, JPN) TAKAMASU TETSUYA (Kanagawa Children's Medical Center, JPN) KOTOYOSE TSUYOSHI (Kanagawa Children's Medical Center, JPN) EBISAWA MOTOHIRO (National Sagamihara Hospital, JPN) TACHIMOTO HIROSHI (National Sagamihara Hospital, JPN) YAMADA SETSU (Kokuritsushonibyoin Ninomiyabun'in Shonika)

Journal Title;Journal of Clinical Therapeutics & Medicines

Journal Code:Y0906A

ISSN:0910-8211

VOL.21;NO.10;PAGE.999-1008(2005)

Figure&Table&Reference;FIG.2, TBL.4, REF.9

Pub. Country;Japan

Language;Japanese

Abstract;Objective: We evaluated the efficacy and safety of montelukast administered as 4mg chewable tablet formulation once daily at bedtime for 4 weeks in 2- to 5-year-old children with bronchial asthma. In addition, the plasma drug concentration of montelukast was measured at around the Tmax or on the next day after the final ingestion of the montelekast, and appropriateness of the 4mg dose of montelukast was examined in 2- to 5-year-old children with bronchial asthma. Method: Following 2 week run-in period without placebo, a 4mg chewable tablet formulation of montelukast was orally administered once a day at bed time for 4 weeks. Results: The frequency of mild attack at week 4 of treatment with 4mg montlukast, as a primary efficacy endpoint, was significantly reduced by 2.95 times/week on average compared to the baseline values. The efficacy rate in the global improvement rating was 69.8% (30/43 patients). Montelukast was considered to be well tolerated, with the safety rate of 93.8% calculated from the global safety rating, a primary safety endpoint. Adverse reactions in the present study were consistent with those domestic and overseas clinical studies previously reported in children aged 6 years and adults. There were no clinically significant adverse reactions specifically observed in the patients aged 2- to 5-year-old. Plasma concentrations-time profile in children aged 2- to 5-year-old with bronchial asthma who received a 4mg chewable tablet formulation of montelukast was comparable with those in pediatric patients (aged 9- to 13-year-old) and healthy adults administered the clinically recommended dose of 5 and 10mg, respectively. Conclusion: These results indicate that treatment with 4mg chewable tablet of montelukast once daily at bedtime is effective and safe in children aged 2- to 5-year-old with bronchial asthma.... (author abst.)

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