Zileuton

PURPOSE: Zileuton Provided Significant Improvement in Pulmonary Function Compared to Placebo in Moderate and Severe Asthmatics.

METHODS: This was a randomized, placebo-controlled, double-blind, parallel, multicenter study of the safety and efficacy of zileuton in patients with asthma. Asthma patients on no chronic asthma treatment other than inhaled beta-agonists were randomized to one of flame treatment groups: zileuton, 600 mg QID, zileuton, 400 mg QID, or placebo for six months. Efficacy assessments included forced expiratory volume (FEV1) and peak expiratory flow rate (PEFR).In an exploratory secondary analysis, 231 asthma patients randomized to treatment were stratified by baseline (BL) percent predicted normal FEV1 into two subgroups: moderate (>60%-<80%; n=133) and severe ([less than or equal to] 60%; n=98). Pulmonary function measurements were obtained on asthmatics on 600 mg zileuton and compared to placebo.

RESULTS: Moderate and severe patients on zileuton experienced significant improvement in FEV1 and A.M. PEFR. This difference was demonstrated as early as 30 minutes post-dose and was sustained throughout the duration of the study. Improvements in P.M. PEFR were also demonstrated.

CONCLUSION: Zileuton, 600 mg QID, provided rapid and sustained improvement in pulmonary function in moderate and severe asthmatic patients versus placebo.

CLINICAL IMPLICATIONS: Zileuton, a 5-lipoyxgenase inhibitor approved for chronic asthma, may improve pulmonary function via its mechanism of action in moderate and severe asthmatics.

DISCLOSURE: William Berger, None.

William Berger MD * Daniel J. Stechschulte MD Karen Walton-Bowen Allergy and Asthma Associates, Mission Viejo, CA

COPYRIGHT 2005 American College of Chest Physicians
COPYRIGHT 2005 Gale Group