@article {1433748,
	title = {Randomized trial of zileuton for treatment of COPD exacerbations requiring hospitalization},
	journal = {COPD},
	volume = {8},
	number = {1},
	year = {2011},
	month = {2011 Feb},
	pages = {21-9},
	abstract = {RATIONALE: Leukotrienes have been implicated in the pathogenesis of acute exacerbations of COPD, but leukotriene modifiers have not been studied as a possible therapy for exacerbations.

OBJECTIVE: We sought to test the safety and efficacy of adding oral zileuton (a 5-lipoxygenase inhibitor) to usual treatment for acute exacerbations of COPD requiring hospitalization.

METHODS: Randomized double-blind, placebo-controlled, parallel group study of zileuton 600 mg orally, 4 times daily versus placebo for 14 days starting within 12 hours of hospital admission for COPD exacerbation. Primary outcome measure was hospital length of stay; secondary outcomes included treatment failure and biomarkers of leukotriene production.

MAIN FINDINGS: Sixty subjects were randomized to zileuton and 59 to placebo (the study was stopped short of enrollment goals because of slow recruitment). There was no difference in hospital length of stay (3.75 +/- 2.19 vs. 3.86 +/- 3.06 days for zileuton vs. placebo, p = 0.39) or treatment failure (23\% vs. 27\% for zileuton vs. placebo, p = 0.63) despite a decline in urinary LTE(4) levels in the zileuton-treated group as compared to placebo at 24 hours (change in natural log-transformed ng/mg creatinine -1.38 +/- 1.19 vs. 0.14 +/- 1.51, p < 0.0001) and 72 hours (-1.32 +/- 2.08 vs. 0.26 +/- 1.93, p,
	keywords = {Aged, Biomarkers, Double-Blind Method, Drug Administration Schedule, Female, Hospitalization, Humans, Hydroxyurea, Length of Stay, Leukotriene B4, Leukotriene E4, Lipoxygenase Inhibitors, Male, Middle Aged, Pulmonary Disease, Chronic Obstructive, Treatment Failure, Treatment Outcome},
	issn = {1541-2563},
	doi = {10.3109/15412555.2010.540273},
	author = {Woodruff, Prescott G and Albert, Richard K and Bailey, William C and Casaburi, Richard and Connett, John E and Cooper, John A D and Criner, Gerard J and Curtis, Jeffrey L and Dransfield, Mark T and Han, MeiLan K and Harnden, Sarah M and Kim, Victor and Marchetti, Nathaniel and Martinez, Fernando J and McEvoy, Charlene E and Niewoehner, Dennis E and Reilly, John J and Rice, Kathryn and Scanlon, Paul D and Scharf, Steven M and Sciurba, Frank C and Washko, George R and Lazarus, Stephen C}
}