Science Links Japan | Cysteinyl Leukotriene Receptor 1 Antagonist; Montelukast, on Childhood Bronchial Asthma in Multicenter Comparative Double-blind Clinical Study (Phase IV) with Ketotifen Fumarate.

Cysteinyl Leukotriene Receptor 1 Antagonist; Montelukast, on Childhood Bronchial Asthma in Multicenter Comparative Double-blind Clinical Study (Phase IV) with Ketotifen Fumarate.

Accession number;05A0586946

Title;Cysteinyl Leukotriene Receptor 1 Antagonist; Montelukast, on Childhood Bronchial Asthma in Multicenter Comparative Double-blind Clinical Study (Phase IV) with Ketotifen Fumarate.

Author; NISHIMA SANKEI (Kokuritsubyoinkiko Fukuokabyoin Shonika) FURUSHO KENSHI (Kokuraarerugikurinikku) FURUKAWA SUSUMU (Yamaguchi Univ., School of Medicine, JPN) YOSHIHARA SHIGEMI (Dokkyo Univ. Sch. of Med.)

Journal Title;Journal of Clinical Therapeutics & Medicines

Journal Code:Y0906A

ISSN:0910-8211

VOL.21;NO.6;PAGE.605-636(2005)

Figure&Table&Reference;FIG.18, TBL.6, REF.17

Pub. Country;Japan

Language;Japanese

Abstract;The efficacy and safety of montelukast for childhood bronchial asthma were examined in a multicenter, double-blind, comparative study (Phase IV: post-marketing study) using ketotifen fumarate as the comparator in 6-14-year-old children with asthma. The daily dose of montelukast was 5mg, while the doses of ketotifen were 2mg for 7-14-year-old children and 1.2mg for 6 year-old children. Both drugs were orally administrated for 4 weeks in 188 children with asthma. The results of the study were as follows: 1) Morning PEF (peak expiratory flow) after 2 week montelukast treatment, the primary endpoint, showed significant improvement compared to the value of ketotifen. This improvement lasted through week four. 2) Treatment with montelukast showed significant improvements in frequency of mild attacks, therapy score, and peripheral blood ensinophil count compared to those of ketotifen. 3) Incidence of adverse experiences of montelukast treatment was not significantly different from that of ketotifen. Adverse experiences related to montelukast treatment were not clinically significant and showed a similar profile with that of ketotifen. Oral administration of 5mg montelukast once daily showed excellent profiles in efficacy, safety and tolerability in children (6-14-year-old children) with bronchial asthma. No significant differences in safety and tolerability were observed between montelukast and ketotifen. These results clearly demonstrated that montelukast sodium is beneficial for the treatment of childhood bronchial asthma. (author abst.)

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