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Worldwide clinical experience with the first marketed leukotriene receptor antagonist.
Chest. 1997 Feb; 111(2 Suppl):52S-60S.Chest

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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Authors+Show Affiliations

Barnes NC
Department of Respiratory Medicine, London Chest Hospital, UK.
de Jong B
No affiliation info available
Miyamoto T
No affiliation info available

MeSH

Anti-Asthmatic AgentsChromonesClinical Trials as TopicDose-Response Relationship, DrugEuropeHumansJapanLeukotriene AntagonistsNorth America

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

9042027

Citation

Barnes, N C., et al. "Worldwide Clinical Experience With the First Marketed Leukotriene Receptor Antagonist." Chest, vol. 111, no. 2 Suppl, 1997, 52S-60S.
Barnes NC, de Jong B, Miyamoto T. Worldwide clinical experience with the first marketed leukotriene receptor antagonist. Chest. 1997;111(2 Suppl):52S-60S.
Barnes, N. C., de Jong, B., & Miyamoto, T. (1997). Worldwide clinical experience with the first marketed leukotriene receptor antagonist. Chest, 111(2 Suppl), 52S-60S.
Barnes NC, de Jong B, Miyamoto T. Worldwide Clinical Experience With the First Marketed Leukotriene Receptor Antagonist. Chest. 1997;111(2 Suppl):52S-60S. PubMed PMID: 9042027.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Worldwide clinical experience with the first marketed leukotriene receptor antagonist. AU - Barnes,N C, AU - de Jong,B, AU - Miyamoto,T, PY - 1997/2/1/pubmed PY - 1997/2/1/medline PY - 1997/2/1/entrez SP - 52S EP - 60S JF - Chest JO - Chest VL - 111 IS - 2 Suppl N2 - 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. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/9042027/Worldwide_clinical_experience_with_the_first_marketed_leukotriene_receptor_antagonist_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(15)43511-1 DB - PRIME DP - Unbound Medicine ER -