The safety and efficacy of zileuton controlled-release tablets as adjunctive therapy to usual care in the treatment of moderate persistent asthma: a 6-month randomized controlled study.

Abstract	This study was conducted to assess the safety and efficacy of zileuton controlled release [CR] 1,200 mg BID added to usual care (UC) in 926 patients with moderate asthma (619 patients randomized to zileuton CR and 307 to placebo). Sustained improvements in AM and PM peak expiratory flow (PEF) were observed in the zileuton CR group compared to placebo. The adverse event profile was similar in the two treatment groups. Eleven patients (1.8%) receiving zileuton CR and 2 (0.7%) receiving placebo experienced elevations of alanine aminotransferase (ALT) >or= 3X the upper limit of normal (ULN). These elevations typically occurred (81.8%) during the first 3 months of exposure and most resolved within 21 days after discontinuation.
Authors	Sally Wenzel, William Busse, William Calhoun, Reynold Panettieri Jr, Mark Peters-Golden, Louise Dube, Karen Walton-Bowen, Heidy Russell, Judith Harris
Journal	The Journal of asthma : official journal of the Association for the Care of Asthma (J Asthma) Vol. 44 Issue 4 Pg. 305-10 (May 2007) ISSN: 0277-0903 [Print] England
PMID	17530530 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References	Adrenergic beta-Agonists Delayed-Action Preparations Glucocorticoids Lipoxygenase Inhibitors Tablets zileuton Hydroxyurea
Topics	Adolescent Adrenergic beta-Agonists (therapeutic use) Adult Aged Aged, 80 and over Asthma (drug therapy) Child Delayed-Action Preparations Double-Blind Method Drug Therapy, Combination Female Forced Expiratory Volume Glucocorticoids (therapeutic use) Humans Hydroxyurea (administration & dosage, adverse effects, analogs & derivatives, therapeutic use) Lipoxygenase Inhibitors (administration & dosage, adverse effects, therapeutic use) Male Middle Aged Peak Expiratory Flow Rate Quality of Life Tablets

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