The Effect of Oral Clarithromycin on Bronchial Airway Inflammation in Moderate-to-Severe Stable COPD
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ORIGINAL RESEARCH ARTICLE
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The Effect of Oral Clarithromycin on Bronchial Airway Inflammation in Moderate-to-Severe Stable COPD A Randomized Controlled Trial Dev Banerjee,1,2 David Honeybourne2 and Omer A. Khair1 1 2
Department of Respiratory Medicine, City Hospital, Birmingham, UK Department of Respiratory Medicine, Birmingham Heartlands Hospital, Birmingham, UK
Abstract
Introduction: COPD is characterized by bronchial neutrophilic inflammation. Clarithromycin is a macrolide antibiotic that has antibacterial and anti-inflammatory properties. Macrolide antibiotics have been shown to improve airway inflammation in diffuse pan-bronchiolitis but their role in COPD is undetermined. The aim of the study was to determine if 3 months of therapy with modified-release oral clarithromycin (Klaricid XL®) 500 mg/day reduced bronchial airway inflammation in patients with moderate-to-severe stable COPD compared with placebo. Methods: A prospective, double-blind controlled trial randomized patients with moderate-to-severe stable COPD to 3 months’ therapy with oral modified-release clarithromycin 500 mg/day or placebo. Patients underwent saline sputum induction before and after treatment with clarithromycin. The effects of clarithromycin on sputum total cell and neutrophil counts, supernatant interleukin-8 (IL-8), leukotriene B4 (LTB4), tumor necrosis factor (TNF)-α, neutrophil elastase (NE), and neutrophil chemotaxis were assessed in comparison with placebo. Results: Of a total of 67 patients included in the trial, 31 were treated with clarithromycin and 36 with placebo. The groups were similar in age, body mass index, history of smoking, and spirometry. Of 60 evaluable patients, 26 and 34 completed 3 months’ therapy with clarithromycin and placebo, respectively. Clarithromycin had no significant effect on sputum total cell count, neutrophil count, IL-8, LTB4, TNFα levels or neutrophil elastase. However, clarithromycin did cause a small reduction in the neutrophil differential (p = 0.04 relative to placebo) and neutrophil chemotaxis (p = 0.058 relative to placebo). Conclusions: Oral clarithromycin 500 mg/day administered for 3 months had no significant effect on sputum neutrophil numbers or cytokine levels in patients with moderate-to-severe stable COPD. However, clarithromycin did cause a small reduction in the neutrophil differential and neutrophil chemotaxis. Further studies may be warranted to determine the clinical significance of these findings.
COPD is a major cause of morbidity and mortality.[1] Airway inflammation in COPD can be regarded as a very complex process with the involvement of neutrophils, lymphocytes, macrophages, and epithelial cells, and mediated through a number of inflammatory proteins such as cytokines. In patients with COPD, induced sputum shows a characteristic increase in the number of neutro-
phils compared with subjects without airway obstruction.[2] Neutrophils from such patients have been shown to exhibit increased chemotactic response to
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