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.

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.
AuthorsSally Wenzel, William Busse, William Calhoun, Reynold Panettieri Jr, Mark Peters-Golden, Louise Dube, Karen Walton-Bowen, Heidy Russell, Judith Harris
JournalThe 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
PMID17530530 (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
  • 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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