LATE-BREAKING ABSTRACT: Prevention of COPD exacerbation by lysozyme: A double-blind, randomized, placebo-controlled study

Abstract

Background /Aim: Lysozyme hydrochroride (mucopeptide N-acetyl muramyl hydrolase; LYS) is widely used as a mucolytic and anti-airway inflammatory agent in Japan. We evaluated the effects of long-term LYS administration on COPD exacerbation. Method: In a 1-year, randomized, double-blind, placebo-control, parallel trial, patients with moderate-to-severe COPD with one or more episodes of COPD exacerbation 1 year before enrollment were enrolled. LYS 270 mg or placebo was orally administered for 52 weeks as an add-on standard therapy such as bronchodilators. COPD exacerbation, CAT scores, and pulmonary function were analyzed. An exacerbation was defined as a worsening of more than one symptom of COPD (cough, sputum volume, purulent sputum, breathlessness) with leading to a change in medication. The primary endpoint was exacerbation frequency (ClinicalTrials.gov number, [NCT01645800][1]). Results: A total of 408 patients were randomly assigned to the LYS and placebo groups. The exacerbation frequency did not show a significant difference between two groups (1.4 vs 1.2; P=0.292, poisson regression). Subgroup analysis showed that LYS might reduce exacerbation frequency in patients with shorter duration of COPD (0.73 vs 1.03), not obvious emphysema (1.2 vs 1.6), and current smoking (1.0 vs 1.2). In post hoc analysis, the adjusted COPD exacerbation frequency was 0.88 and 1.22 in the LYS and placebo group, respectively (P=0.026; poisson regression). Conclusion: Add-on LYS treatment may reduce exacerbation in some type of COPD patients. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01645800&atom=%2Ferj%2F46%2Fsuppl_59%2FPA4359.atom