Journal
COPD-JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Volume 8, Issue 1, Pages 21-29Publisher
INFORMA HEALTHCARE
DOI: 10.3109/15412555.2010.540273
Keywords
Chronic Obstructive Pulmonary Disease (COPD); Acute exacerbation of COPD (AECOPD); Leukotrienes; Zileuton; Clinical trial
Categories
Funding
- National Heart, Lung and Blood Institute [U10 HL074441, U10 HL074418, U10 HL074428, U10 HL074409, U10 HL074407, U10 HL074422, U10 HL074416, U10 HL074408, U10 HL074439, U10 HL074431, U10HL074424]
- Division of Lung Diseases of the National Heart, Lung, and Blood Institute
- National Center for Research Resources
- Brigham and Women's Hospital
- GCRC [RR02635, RR00051, RR00425, RR16500, RR00056]
- Forrest Laboratories
- Boehringer Ingelheim
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Nycomed
- Forest Research Institute
- Adams Respiratory Therapeutics
- Aeris
- Allegro
- Altana/Nycomed/Forest
- Roche
- Novartis
- Respironics
- Forest
- Medimmune/Astra Zeneca
- Schering
- Actelion
- Forest/Almirall
- Bayer
- HLS
- Merck
- Pearl
- UBC
- Mpex
- Talecris
- Comgenix
- BoomComm
- France Foundation
- NACE
- MedEd
- Potomac
- fb Communications
- Vox Medic
- American Lung Association
- WebMD
- HIT Global
- NIH
- [HL074428]
- [HL074409]
- [HL074407]
- [1U10-HL074416]
- [HL074408]
- [HL074418]
- [1U10-HL074431]
- [HL074441]
- [HL074422]
- [HL074439]
- [1U10-HL074424]
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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 < 0.006). Adverse events were similar in both groups. Principal Conclusions: While oral zileuton during COPD exacerbations that require hospital admission is safe and reduces urinary LTE(4) levels, we found no evidence suggesting that this intervention shortened hospital stay, with the limitation that our sample size may have been insufficient to detect a modest but potentially meaningful clinical improvement.
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