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

doi:10.1080/02770900701344199

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

Internal Medicine

Research output: Contribution to journal › Article › peer-review

24 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 language	English (US)
Pages (from-to)	305-310
Number of pages	6
Journal	Journal of Asthma
Volume	44
Issue number	4
DOIs	https://doi.org/10.1080/02770900701344199
State	Published - May 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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10.1080/02770900701344199

Cite this

Wenzel, S., Busse, W., Calhoun, W., Panettieri, R., Peters-Golden, M., Dube, L., Walton-Bowen, K., Russell, H., & Harris, J. (2007). 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. Journal of Asthma, 44(4), 305-310. https://doi.org/10.1080/02770900701344199

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. / Wenzel, Sally; Busse, William; Calhoun, William et al.
In: Journal of Asthma, Vol. 44, No. 4, 05.2007, p. 305-310.

Research output: Contribution to journal › Article › peer-review

Wenzel, S, Busse, W, Calhoun, W, Panettieri, R, Peters-Golden, M, Dube, L, Walton-Bowen, K, Russell, H & Harris, J 2007, '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', Journal of Asthma, vol. 44, no. 4, pp. 305-310. https://doi.org/10.1080/02770900701344199

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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.",

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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

Keywords

ASJC Scopus subject areas

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