Science Links Japan | A Cysteinyl Leukotriene Receptor 1 Antagonist; MK-476 (Montelukast), in Childhood Bronchial Asthma; A Multicenter, Long-term, Open study (Phase III)

A Cysteinyl Leukotriene Receptor 1 Antagonist; MK-476 (Montelukast), in Childhood Bronchial Asthma; A Multicenter, Long-term, Open study (Phase III)

Accession number;05A0670254

Title;A Cysteinyl Leukotriene Receptor 1 Antagonist; MK-476 (Montelukast), in Childhood Bronchial Asthma; A Multicenter, Long-term, Open study (Phase III)

Author; FURUSHO KENSHI (Shiritsukishiwadashiminbyoin Shonika) NISHIMA SANKO (National Minami Fukuoka Chest Hospital, JPN) FURUKAWA SUSUMU (Yamaguchidai I Byoin Shonika) KONDO NAOMI (Gifudai I Byoin Shonika) SHINOMIYA KEISUKE (Kokuritsuhimejibyoin Shonika) IIKURA YOJI (Showa Univ., School of Medicine, JPN) SAITO HIROHISA (Kokuritsushonibyoin Men'ekiarerugikenkyubu) AKAZAWA AKIRA (National Children's Hospital, JPN) AKASAKA TOORU (Kokuritsuryoyoshomoriokabyoin Shonika) WADA HIROYASU (Kokuritsuryoyoshomoriokabyoin Shonika) OHARA RIEKO (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) NISHIMURA HIDEKO (Gunmadai I Byoin Shonika) SAGA REIKO (Gunmadai I Byoin Shonika) NAGAYAMA YOKO (Chiba Children's Hospital, JPN) TOBA GO (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) SUZUKI AKIICHI (Showadai Byoin Shonika) TAKAMURA MAYUMI (Showadai Byoin Shonika) KATSUNUMA TOSHIO (Kokuritsushonibyoin Shonika) IMAMURA NAOTO (Kokuritsushonibyoin Shonika) OYA YUKIHIRO (Kokuritsushonibyoin Shonika) SUDA TOMOKO (Kokuritsushonibyoin Shonika) KAWAHARA HIDETOSHI (Kokuritsushonibyoin Shonika) MORISAWA YUTAKA (Kokuritsushonibyoin Shonika) KOYAMA NORIKO (Doai Kinen Byoin) AOKI KUNITERU (Doai Kinen Byoin) KURIHARA KAZUYUKI (Kanagawa Children's Medical Center, JPN) TAKAMASU TETSUYA (Kanagawa Children's Medical Center, JPN) EBISAWA MOTOHIRO (National Sagamihara Hospital, JPN)

Journal Title;Journal of Clinical Therapeutics & Medicines

Journal Code:Y0906A

ISSN:0910-8211

VOL.21;NO.7;PAGE.711-731(2005)

Figure&Table&Reference;FIG.7, TBL.11, REF.17

Pub. Country;Japan

Language;Japanese

Abstract;The safety, efficacy and usefulness of montelukast 5 mg chewable tablet in pediatric patients of 6 years old upward with mild to moderate pediatric bronchial asthma were examined in a long-term administration study. One montelukast 5 mg chewable tablet was administered once daily for 12 weeks. Thereafter, administration was extended to when patients wished continuous administration (range 24 to 579 days). The results of the study were as follows: 1) The primary endpoint of the efficacy ratio in the final global improvement (proportion of (markedly improved + moderately improved) was 80.9% (38/47) in the patients treated for 12 weeks, and 84.8% (28/33 patients) in the patients treated during the extended treatment period. 2) The secondary endpoint of efficacy in the global improvement was consistent during a long-term administration in each period. 3) The primary endpoint of the safety ratio in the overall safety (proportion of very safe) was 97.9% (47/48) in patients treated for 12 weeks and 100% (33/33) in the patients treated during the extended treatment period. Adverse reactions were observed only in one patient throughout the study periods. Long-term administration of montelukast 5 mg chewable tablet once daily showed effectiveness in the patients with pediatric bronchial asthma without decrease in efficacy for more than 12 weeks. There was no problematic finding regarding safety. These results clearly indicated that montelukast 5 mg chewable tablet may be a useful long-term-control drug for patients of 6 years old upward with pediatric bronchial asthma, as similar to adult patients. (author abst.)

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