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

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

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

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: Lysozyme hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
  • Oita, Japan
  • Osaka, Japan
  • Yamagata, Japan
  • Aichi
    • Nishio, Aichi, Japan
  • Chiba
    • Noda, Chiba, Japan
  • Fukuoka
    • Kasuga, Fukuoka, Japan
    • Kyoto-gun, Fukuoka, Japan
    • Yanagawa, Fukuoka, Japan
  • Gunma
    • Mabashi, Gunma, Japan
    • Takasaki, Gunma, Japan
  • Hokkaido
    • Kitahiroshima, Hokkaido, Japan
    • Sapporo, Hokkaido, Japan
  • Hyogo
    • Himeji, Hyogo, Japan
  • Kagawa
    • Takamatsu, Kagawa, Japan
  • Kanagawa
    • Yokohama, Kanagawa, Japan
    • Yokosuka, Kanagawa, Japan
  • Niigata
    • Nagaoka, Niigata, Japan
  • Okyama
    • Okayama, Okyama, Japan
  • Osaka
    • Suita, Osaka, Japan
  • Tokyo
    • Chuo-ku, Tokyo, Japan
    • Edogawa-ku, Tokyo, Japan
    • Higashikurume, Tokyo, Japan
    • Koto-ku, Tokyo, Japan
    • Setagaya-ku, Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Matching Placebo capsule: Three times daily for 52 weeks.
EXPERIMENTAL: Lysozyme hydrochloride	Drug: Lysozyme hydrochloride; LYL 90mg capsule: Three times daily for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute exacerbation of COPD	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Yearly reduction in FEV1 and QOL assessed by CAT	52 weeks

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Study Director: Yukinori Sakata, Drug Fostering and evolution Coodination Department, Corporate Regulattory Compliance, Safety and Quality Assurance Headquaters, Eisai Co., Ltd., Japan

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (ESTIMATE): July 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: COPD; Lysozyme hydrochloride
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anti-Infective Agents; Muramidase
• Other Study ID Numbers: LYS-002