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Worldwide Clinical Experience With the First Marketed Leukotriene Receptor Antagonist

Neil C. Barnes; Bert de Jong; Terumasa Miyamoto
Author and Funding Information

Affiliations: From the Department of Respiratory Medicine, The London Chest Hospital, London, UK,  From the Department of Clinical Research and Development, SmithKline Beecham Pharmaceuticals, Collegeville, Pa,  From the Department of Medicine and Physical Therapy, University of Tokyo School of Medicine, Tokyo, Japan

Affiliations: From the Department of Respiratory Medicine, The London Chest Hospital, London, UK,  From the Department of Clinical Research and Development, SmithKline Beecham Pharmaceuticals, Collegeville, Pa,  From the Department of Medicine and Physical Therapy, University of Tokyo School of Medicine, Tokyo, Japan

Affiliations: From the Department of Respiratory Medicine, The London Chest Hospital, London, UK,  From the Department of Clinical Research and Development, SmithKline Beecham Pharmaceuticals, Collegeville, Pa,  From the Department of Medicine and Physical Therapy, University of Tokyo School of Medicine, Tokyo, Japan


1997 by the American College of Chest Physicians


Chest. 1997;111(2_Supplement):52S-60S. doi:10.1378/chest.111.2_Supplement.52S
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Abstract

Pranlukast (SB 205312, ONO-1078) is an orally active, potent, selective blocker of peptidyl-leukotriene receptors. Pranlukast has been studied in a worldwide clinical development program and recently was approved in Japan for the treatment of asthma. This worldwide experience includes a pivotal safety and efficacy study conducted in Japan, a leukotriene D4 (LTD4) challenge study conducted in Europe, and two safety, tolerability, and clinical activity studies conducted in Europe and North America. The pivotal study was a randomized, double-blind, 8-week comparison of pranlukast, 225 mg bid, and azelastine, 2 mg bid. Improvements in asthma symptom scores, morning and evening peak expiratory flow rate (PEFR), and a decreased need for bronchodilators and corticosteroids in the pranlukast-treated group were statistically significant when compared with those in the azelastine-treated group. The most common adverse experiences were GI. The European challenge study evaluated the ability of 5-day therapy with pranlukast, 450 mg bid, to block the bronchoconstrictor effect of inhaled LTD4. A single dose of pranlukast resulted in a 10.6-fold increase in the concentration of LTD4 required to produce a 35% decrease in specific airways conduction; following 5 days of therapy, this increased to 25.9-fold. The two safety, tolerability, and clinical activity studies were randomized, double-blind, placebo-controlled, 4-week evaluations of pranlukast, 225 to 450 mg bid. Improvements in FEV1, PEFR, and asthma symptoms were noted. Ongoing studies will define further the role of pranlukast as a treatment for asthma and allergic rhinitis.


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