Back to resultsEffects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
Primary Purpose
COPD
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Lysozyme hydrochloride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring Lysozyme hydrochloride, COPD
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lysozyme hydrochloride
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Acute exacerbation of COPD
Secondary Outcome Measures
Yearly reduction in FEV1 and QOL assessed by CAT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01645800
Brief Title
Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
Official Title
Effects of Lysozyme On Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Lysozyme hydrochloride, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
408 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lysozyme hydrochloride
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lysozyme hydrochloride
Intervention Description
LYL 90mg capsule: Three times daily for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo capsule: Three times daily for 52 weeks.
Primary Outcome Measure Information:
Title
Acute exacerbation of COPD
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Yearly reduction in FEV1 and QOL assessed by CAT
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yukinori Sakata
Organizational Affiliation
Drug Fostering and evolution Coodination Department, Corporate Regulattory Compliance, Safety and Quality Assurance Headquaters, Eisai Co., Ltd., Japan
Official's Role
Study Director
Facility Information:
City
Nishio
State/Province
Aichi
Country
Japan
City
Noda
State/Province
Chiba
Country
Japan
City
Kasuga
State/Province
Fukuoka
Country
Japan
City
Kyoto-gun
State/Province
Fukuoka
Country
Japan
City
Yanagawa
State/Province
Fukuoka
Country
Japan
City
Mabashi
State/Province
Gunma
Country
Japan
City
Takasaki
State/Province
Gunma
Country
Japan
City
Kitahiroshima
State/Province
Hokkaido
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Himeji
State/Province
Hyogo
Country
Japan
City
Takamatsu
State/Province
Kagawa
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Yokosuka
State/Province
Kanagawa
Country
Japan
City
Nagaoka
State/Province
Niigata
Country
Japan
City
Okayama
State/Province
Okyama
Country
Japan
City
Suita
State/Province
Osaka
Country
Japan
City
Chuo-ku
State/Province
Tokyo
Country
Japan
City
Edogawa-ku
State/Province
Tokyo
Country
Japan
City
Higashikurume
State/Province
Tokyo
Country
Japan
City
Koto-ku
State/Province
Tokyo
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
City
Fukuoka
Country
Japan
City
Oita
Country
Japan
City
Osaka
Country
Japan
City
Yamagata
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
We'll reach out to this number within 24 hrs