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Title: Erdosteine Has Antioxidants Benefits in COPD Patients Who Still Smoke: Presented at ERS

"Erdosteine Has Antioxidants Benefits in COPD Patients Who Still Smoke: Presented at ERS"

By Paula Moyer MUNICH, GERMANY -- September 11, 2006 -- The mucolytic drug erdosteine has antioxidant benefits in patients with chronic obstructive pulmonary disease (COPD) who continue to smoke, according to investigators who presented their findings here at the 16[^th annual meeting of the European Respiratory Society (ERS).

"This is the first known mucolytic drug developed to treat COPD," said principal investigator Roberto W. Dal Negro, MD, chief of pulmonology, Orlandi Hospital, Bussolengo, Italy.

"In this study, we also found that it has a significant effect against oxidative stress. We could see quite a significant effect in 3 days, and a restoration of the pulmonary membrane in 10 days," Dr. Dal Negro said in an interview on September 4^th.

The investigators conducted the study because of the known oxidative stress caused by cigarette smoking, and therefore, potential benefit that any antioxidant interventions could have for patients with COPD who smoking. Erdosteine is currently under investigation for management of former smokers with COPD, but its benefits for patients who continue to smoke are not known, according to the researchers.

For their double-blind, placebo-controlled study, Dr. Dal Negro and colleagues enrolled 20 patients with COPD who were an average of 65 years old. These patients were randomized them into 2 treatment groups -- erdosteine 600 mg daily for 10 days or placebo.

The treatment group had an average forced expiratory volume in 1 second (FEV₁) of 88.7% of predicted and the placebo group's average was 85.2% of predicted. Average cumulative cigarette consumption was 25.4 pack-years for the treatment group and 28.1 pack-years for the placebo group.

Patients' levels of interleukin-6 (IL-6), IL-8, tumor necrosis factor-alpha (TNF-a), and 8-isoprostane in bronchial secretions were evaluated at baseline and at days 4, 7, and 10. The investigators also measured peripheral blood levels of e-nitrous oxide and oxidative stress in blood.

Blood oxidative stress and IL-8 in bronchial secretions decreased significantly starting on day 4 of treatment (both P < .01). Levels of 8-isoprostane decreased after day 10 (P < .02). The decrease in e-nitrous oxide levels was not significant. The investigators observed no significant changes in the placebo group.

Based on these data, the investigators concluded that erdosteine has an inhibitory effect on some of the pro-inflammatory cytokines that promote oxidative stress in current smokers with mild COPD.

The investigators plan to study the antioxidative impact of erdosteine in COPD in longer-term studies.

[Presentation title: Anti-Oxidant Effects of Erdosteine in Current Smokers With Mild COPD. Abstract 2507]

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