Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study

Overview

The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.

Full Title of Study: “Effects of Lysozyme On Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2015

Interventions

  • Drug: Lysozyme hydrochloride
    • LYL 90mg capsule: Three times daily for 52 weeks.
  • Drug: Placebo
    • Matching Placebo capsule: Three times daily for 52 weeks.

Arms, Groups and Cohorts

  • Experimental: Lysozyme hydrochloride
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Acute exacerbation of COPD
    • Time Frame: 52 weeks

Secondary Measures

  • Yearly reduction in FEV1 and QOL assessed by CAT
    • Time Frame: 52 weeks

Participating in This Clinical Trial

Inclusion criteria;

  • Patients were eligible for inclusion in the study if they were over 20 years of age and below 85 years of age, and had a smoking history, a diagnosis of COPD, a ratio of FEV1 to forced vital capacity(FVC) of less than 70%, and a documented history of at least one exacerbation leading to any treatment within the previous year. Exclusion criteria; – Patients with egg allergy – Patients with domiciliary oxygen therapy – Patients with pneumonia or pulmonary tuberculosis – Patients with severe cardiovascular disorder,severe kidney disorder, severe hepatic disorder, severe hematological disorder. – Patients with cancer.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 84 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yukinori Sakata, Study Director, Drug Fostering and evolution Coodination Department, Corporate Regulattory Compliance, Safety and Quality Assurance Headquaters, Eisai Co., Ltd., Japan

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.