Clinical effects of pranlukast, an oral leukotriene receptor antagonist, in mild-to-moderate asthma: a 4 week randomized multicentre controlled trial

• Published in: Respirology (Carlton, Vic.) Vol. 6; no. 1; pp. 15 - 21
• Main Authors: Yoo, S H, Park, S H, Song, J S, Kang, K H, Park, C S, Yoo, J H, Choi, B W, Hahn, M H
• Format: Journal Article
• Language: English
• Published: Australia 01-03-2001
• Subjects: Adrenergic beta-Agonists - therapeutic use; Adult; Aged; Analysis of Variance; Asthma - drug therapy; Chromones - therapeutic use; Consumer Product Safety; Double-Blind Method; Female; Forced Expiratory Volume - drug effects; Humans; Leukotriene Antagonists - adverse effects; Leukotriene Antagonists - therapeutic use; Male; Middle Aged; Peak Expiratory Flow Rate - drug effects
• ISSN: 1323-7799; 1440-1843
• DOI: 10.1046/j.1440-1843.2001.00291.x

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.
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 beta2-agonists and/or inhaled corticosteroids were studied. The patients' symptoms were evaluated by asthma diary and twice-daily peak flow monitoring.
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 beta2-agonist. Compared with the placebo group, forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV1) 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.
Pranlukast, an oral leukotriene antagonist, was well tolerated and was effective for the management of mild-to-moderate asthma.