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Laboratory and Animal Investigations |

A Randomized, Placebo-Controlled Trial of a Leukotriene Synthesis Inhibitor in Patients With COPD*

Simon Gompertz, MD; Robert A. Stockley, DSc
Author and Funding Information

*From the Department of Respiratory Medicine, Queen Elizabeth Hospital, Birmingham, UK.

Correspondence to: Simon Gompertz, MD, Lung Investigation Unit, First Floor, Nuffield House, Queen Elizabeth Hospital, Edgbaston, Birmingham B15 2 TH, UK; e-mail: sgomp@doctors.org.uk



Chest. 2002;122(1):289-294. doi:10.1378/chest.122.1.289
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Study objective: Patients with COPD classically have neutrophilic bronchial inflammation and raised airway concentrations of the neutrophil chemoattractant leukotriene B4 (LTB4). A small phase II trial was conducted to assess the effects of a leukotriene synthesis inhibitor on bronchial inflammation in patients with stable COPD.

Design: A randomized, double-blind, placebo-controlled, parallel-group study.

Setting: Respiratory medicine department of a university hospital.

Patients and intervention: Seventeen patients with chronic bronchitis and COPD (mean FEV1, 35.5% predicted; SD, 14.8% predicted) were randomized to receive 14 days of the oral leukotriene synthesis inhibitor BAYx1005 (500 mg bid) or placebo.

Measurements and results: Spontaneous sputum samples obtained at baseline and at the end of treatment were assayed for LTB4, myeloperoxidase (an indirect marker of neutrophil numbers and/or activation), and chemotactic activity (Boyden chamber). After 14 days, there were no significant differences (p > 0.05) in absolute LTB4 concentrations between the two treatment groups. However, BAYx1005 treatment produced a significantly greater median reduction in LTB4 of − 3.1 nM (interquartile range [IQR], − 9.6 to − 0.2 nM) vs 3.0 nM (IQR, − 0.3 to 8.5 nM) [p = 0.001], with concentrations decreasing from 8.0 nM (IQR, 4.3 to 24.4 nM) at baseline to 4.2 nM (IQR, 1.9 to 11.9 nM) at the end of treatment (p = 0.03). There were no changes in the placebo group and no differences in sputum myeloperoxidase concentration or chemotaxis between the two treatment arms (p > 0.05).

Conclusions: This small study suggests that a leukotriene synthesis inhibitor can produce modest reductions in some measures of neutrophilic bronchial inflammation in patients with COPD. This class of anti-inflammatory agent requires further study in larger numbers of patients to determine clinical benefit.

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