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Clinical effects of pranlukast, an oral leukotriene receptor antagonist, in mild‐to‐moderate asthma: A 4 week randomized multicentre controlled trial
Author(s) -
Yoo Se Hwa,
Park Sung Hak,
Song Jeong Sup,
Kang Kyung Ho,
Park Choon Sik,
Yoo Jee Hong,
Choi Byoung Whui,
Hahn Myung Ho,
Group Representing Korea Pranlukast Study
Publication year - 2001
Publication title -
respirology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.857
H-Index - 85
eISSN - 1440-1843
pISSN - 1323-7799
DOI - 10.1111/j.1440-1843.2001.00291.x
Subject(s) - medicine , asthma , evening , placebo , leukotriene receptor , morning , adverse effect , randomized controlled trial , vital capacity , anesthesia , leukotriene , lung , lung function , physics , alternative medicine , pathology , astronomy , diffusing capacity
Objective: Leukotriene antagonists are increasingly used in asthma management. Pranlukast is a new, orally active, selective inhibitor of CysLt1 leukotriene receptor. The present clinical trial was performed to study the effect and safety of pranlukast in mild‐to‐moderate asthma. Methodology: A randomized, double‐blind, placebo‐controlled, parallel group study was performed in eight medical centres in Korea. Mild‐to‐moderate asthma patients who had been treated with β 2 ‐agonists and/or inhaled corticosteroids were studied. The patients' symptoms were evaluated by asthma diary and twice‐daily peak flow monitoring. Results: Of the 206 patients enrolled, 197 were eligible for analysis. The pranlukast group ( n = 98) showed statistically significant improvement in asthma symptoms, including asthma attack rate, daily living score, and morning and evening asthma scores. Pranlukast significantly reduced the consumption of β 2 ‐agonist. Compared with the placebo group, forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV 1 ) were not significantly higher in the pranlukast group. Morning and evening peak expiratory flow (PEF) were significantly increased after pranlukast treatment at weeks 2 and 4 (380.8 ± 10.1 L/min at baseline, 394.5 ± 10.1 at week 2, 396.3 ± 10.4 at week 4). There were no serious adverse reactions. Conclusion: Pranlukast, an oral leukotriene antagonist, was well tolerated and was effective for the management of mild‐to‐moderate asthma.