Zileuton Provided Significant Improvement in Pulmonary Function Compared to Placebo in Moderate and Severe Asthmatics.
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 three 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 (≤60%; n=98). Pulmonary function measurements were obtained on asthmatics on 600 mg zileuton and compared to placebo.
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.
Zileuton, 600 mg QID, provided rapid and sustained improvement in pulmonary function in moderate and severe asthmatic patients versus placebo.
Zileuton, a 5-lipoyxgenase inhibitor approved for chronic asthma, may improve pulmonary function via its mechanism of action in moderate and severe asthmatics.
William Berger, None.Severity GroupDifference From Placebo in Mean Change From BL to Post-Dose in FEV1 (L)Difference From Placebo in Mean Change From BL in A.M. PEFR (L/Min)Month 3Month 630 Mins60 Mins120 Mins30 Mins60 Mins120 MinsDays 2-22Days 163-190Moderate0.19*0.26**0.16♦μ0.110.120.18♦μ17.76**11.47Severe0.35*0.30*0.28♦μ0.27♦μ0.33*0.32♦μ15.93*30.24***