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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-03-31

Brief Summary

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

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lysozyme hydrochloride

Group Type EXPERIMENTAL

Lysozyme hydrochloride

Intervention Type DRUG

LYL 90mg capsule: Three times daily for 52 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo capsule: Three times daily for 52 weeks.

Interventions

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Lysozyme hydrochloride

LYL 90mg capsule: Three times daily for 52 weeks.

Intervention Type DRUG

Placebo

Matching Placebo capsule: Three times daily for 52 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yukinori Sakata

Role: STUDY_DIRECTOR

Drug Fostering and evolution Coodination Department, Corporate Regulattory Compliance, Safety and Quality Assurance Headquaters, Eisai Co., Ltd., Japan