Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom

July 17, 2014 updated by: Eisai Co., Ltd.

Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study

The aim of this study was to assess the effectiveness for small airway inflammation of 4 weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Gifu
      • Mizunami, Gifu, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

For COPD:

  • Over 20 years of age and below 85 years of age
  • Smoking history
  • Brinkman index 200 or more
  • Diagnosis of COPD
  • Forced expiratory volume in 1 second (FEV1) of <80% of the predicted value
  • Ratio of FEV1 to forced vital capacity (FVC) of <70%
  • symptom of expectorated sputum

For Asthma

  • Over 20 years of age and below 85 years of age
  • Scored between 20 to 24 by ACT (Asthma Control Test)
  • Symptom of expectorated sputum
  • Diagnosed partly controlled by global initiative for asthma

Exclusion criteria:

  • Egg allergy
  • Domiciliary oxygen therapy
  • Pneumonia or pulmonary tuberculosis
  • Patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic disorder, severe hematological disorder
  • Cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)
Other Names:
  • PRT10T
Experimental: Lysozyme 90 mg
Drug: lysozyme 90 mg
Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)
Other Names:
  • PRT10T

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of several inflammatory or biochemical marker concentration in inducted sputum
Time Frame: 8 weeks (2 periods each lasting 4 weeks)
8 weeks (2 periods each lasting 4 weeks)
Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.
Time Frame: 8 weeks (2 periods each lasting 4 weeks)
8 weeks (2 periods each lasting 4 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Monthly reduction in forced expiratory volume in 1 Second (FEV1)
Time Frame: 8 weeks (2 periods each lasting 4 weeks)
8 weeks (2 periods each lasting 4 weeks)
Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)
Time Frame: 8 weeks (2 periods each lasting 4 weeks)
8 weeks (2 periods each lasting 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Investigators

  • Study Director: Kai Shibata, Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYS-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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