Prevention of COPD exacerbation by lysozyme: a double-blind, randomized, placebo-controlled study
| Autor: | Kai Shibata, Hiromasa Inoue, Masakazu Ichinose, Hideaki Miyagishi, Koichiro Tatsumi, Yoshinosuke Fukuchi, Yukinori Sakata, Yasuhiro Marukawa |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_specialty Exacerbation forced expiratory volume in 1 second Placebo-controlled study Subgroup analysis International Journal of Chronic Obstructive Pulmonary Disease Placebo Pulmonary function testing 03 medical and health sciences chemistry.chemical_compound COPD exacerbation Pulmonary Disease Chronic Obstructive 0302 clinical medicine Double-Blind Method Internal medicine Clinical endpoint Medicine Humans 030212 general & internal medicine lysozyme Original Research Aged COPD business.industry General Medicine medicine.disease respiratory tract diseases 030228 respiratory system chemistry Immunology Disease Progression COPD assessment test Female Muramidase Lysozyme business |
| Zdroj: | International Journal of Chronic Obstructive Pulmonary Disease |
| ISSN: | 1178-2005 1176-9106 |
| Popis: | Yoshinosuke Fukuchi,1 Koichiro Tatsumi,2 Hiromasa Inoue,3 Yukinori Sakata,4 Kai Shibata,4 Hideaki Miyagishi,4 Yasuhiro Marukawa,4 Masakazu Ichinose5 1Department of Respiratory Medicine, Graduate School of Medicine, Juntendo University, Tokyo, 2Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, 3Department of Pulmonary Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, 4Eisai Co., Ltd., Tokyo, 5Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan Background/aim: Lysozyme (mucopeptide N-acetyl-muramyl hydrolase) is widely used as a mucolytic and anti-inflammatory agent in Japan. We evaluated the effects of long-term lysozyme administration on COPD exacerbation. Methods: In a 1-year, randomized, double-blind, placebo-controlled, parallel trial, patients with moderate-to-severe COPD and one or more episodes of COPD exacerbation in the previous year before enrollment were selected. Lysozyme (270mg) or placebo was administered orally for 52weeks as an add-on to the standard therapies such as bronchodilators. COPD exacerbation, pulmonary function, and COPD assessment test scores were analyzed. An exacerbation was defined as worsening of more than one symptom of COPD (cough, sputum volume, purulent sputum, or breathlessness) leading to a change in medication. The primary endpoint was exacerbation rate. Results: A total of 408 patients were randomly assigned to the lysozyme and placebo groups. The baseline characteristics were similar between the two groups. The exacerbation rate was not significantly different between the two groups (1.4 vs 1.2; P=0.292, Poisson regression). However, a subgroup analysis showed that lysozyme might reduce exacerbation rate in patients with airway-dominant phenotype (1.2 vs 1.6). Moreover, the median time to first exacerbation was longer in patients with airway-dominant phenotype in the lysozyme group than that in the placebo group. The levels of improvement in forced expiratory volume in 1second and COPD assessment test scores were not statistically different between the groups, but were always greater in the lysozyme group than in the placebo group over the 52weeks of the study. Conclusion: The effects of using lysozyme as an add-on to standard COPD therapy were not significantly different compared with placebo and were insufficient to prevent COPD exacerbation. Keywords: lysozyme, COPD exacerbation, forced expiratory volume in 1second, COPD assessment test |
| Databáze: | OpenAIRE |
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