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

Sally Wenzel, William Busse, William Calhoun, Reynold Panettieri, Mark Peters-Golden, Louise Dube, Karen Walton-Bowen, Heidy Russell, Judith Harris

Research output: Contribution to journalArticle

23 Scopus citations

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) ≥ 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.

Original languageEnglish (US)
Pages (from-to)305-310
Number of pages6
JournalJournal of Asthma
Volume44
Issue number4
DOIs
StatePublished - May 1 2007

Keywords

  • Adjunctive therapy
  • Asthma
  • Controlled-release
  • Zileuton

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Immunology and Allergy
  • Pulmonary and Respiratory Medicine

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