A Non-controlled Phase II Open-label Study of Montelukast Fine Granules, a Cysteinyl Leukotriene Receptor 1 Antagonist, in Children Aged 1-year-old with Bronchial Asthma
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Accession number;05A0945094
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| Title;A Non-controlled Phase II Open-label Study of Montelukast Fine Granules, a Cysteinyl Leukotriene Receptor 1 Antagonist, in Children Aged 1-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)
SAITO HIROHISA
(Kokuritsuseiikuiryose Ken Men'ekiarerugikenkyubu)
AKAZAWA AKIRA
(Kokuritsuseiikuiryose Shonikishinryoka)
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.)
KATSUNUMA TOSHIO
(Tokyojikeikaiidai Byoin Shonika)
FUKAWA MORIMITSU
(Tokyojikeikaiidai Byoin Shonika)
ODAJIMA YASUHIRA
(Showadai Byoin Shonika)
KITABAYASHI SHINOBU
(Showadai Byoin Shonika)
MIURA KATSUSHI
(Showadai Byoin Shonika)
IMAI TAKANORI
(Showadai Byoin Shonika)
SHIBATA JUN
(Kokuritsuseiikuiryose Shonikishinryoka)
KAWAHARA HIDETOSHI
(Kokuritsuseiikuiryose Shonikishinryoka)
KAMIYA TARO
(Kokuritsuseiikuiryose Shonikishinryoka)
OYA YUKIHIRO
(Kokuritsuseiikuiryose Arerugika)
SUDA YUKO
(Kokuritsuseiikuiryose Arerugika)
SHINOHARA SHIMEKAZU
(Kokuritsuseiikuiryose Arerugika)
WATANABE HIROKO
(Kokuritsuseiikuiryose Arerugika)
MUKOYAMA TOKUKO
(Doai Kinen Byoin)
AOKI KUNITERU
(Doai Kinen Byoin)
NAKAZONO HIRONORI
(Doai Kinen Byoin)
EBISAWA MOTOHIRO
(National Sagamihara Hospital, JPN)
TACHIMOTO HIROSHI
(National Sagamihara Hospital, JPN)
IGUCHI KOSEI
(National Mie Hospital, JPN)
ATSUTA JUN
(National Mie Hospital, JPN)
FUJISAWA TAKAO
(Kokuritsuryoyoshomiebyoin Arerugika)
IGAMI YOSHISUKE
(Gifudai I Byoin Shonika)
TERAMOTO TAKAHIDE
(Gifudai I Byoin Shonika)
MATSUI EIKO
(Gifudai I Byoin Shonika)
MATSUBARA TOMOYO
(Yamaguchidai I Byoin Shonika)
MOTOMURA CHIKAKO
(National Minami Fukuoka Chest Hospital, JPN)
HAMASAKI YUHEI
(Sagaidai I Byoin Shonika)
ICHIMARU TOMOHIRO
(Sagaidai I Byoin Shonika)
ZAITSU MASAFUMI
(Sagaidai I Byoin Shonika)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.21;NO.10;PAGE.1009-1018(2005)
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| Figure&Table&Reference;FIG.3, TBL.2, REF.18 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Objective: We investigated safety of montelukast 4mg fine granule in children aged 1-year-old with bronchial asthma. In addition, the plasma drug concentration at 4-week administration of montelukast 4mg fine granule was examined, and was compared with the plasma drug concentration after administration of the optimal doses of montelukast in other age groups. Method: Following 2-week run-in period without placebo, one pouch of montelukast 4mg fine granule was orally administered to children aged 1-year-old with bronchial asthma once a day for 4 weeks. Results: The safety rate in the global safety as the primary endpoint was as high as 94.1% (16/17 patients). An adverse reaction (clinical or laboratory) was reported in only one patient. The plasma concentrations of montelukast after administration of 4mg fine granules were generally similar to the mean plasma concentrations in healthy adult volunteers and pediatric patients aged 9- to 13-year-old after administration of the clinically recommended dose (a 10mg film coated tablet for adults; a 5mg chewable tablet for children aged 6-year-old and above). The efficacy rate in the global improvement rating was 52.9% (9/17 patients) by the exploratory efficacy analysis. Conclusion: These results indicated that the administration of montelukast 4mg fine granules is well-tolerated and considered to be an appropriate dose for children aged 1-year-old with bronchial asthma. (author abst.) |
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