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

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 beta2-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 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.

CONCLUSION

Pranlukast, an oral leukotriene antagonist, was well tolerated and was effective for the management of mild-to-moderate asthma.