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

NCT ID: NCT01715493

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-01-31

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lysozyme 90 mg

Group Type: EXPERIMENTAL

lysozyme 90 mg

Intervention Type: DRUG

Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)

Interventions

lysozyme 90 mg

Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

PRT10T; PRT10T

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai Shibata

Role: STUDY_DIRECTOR

Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters

Locations

Mizunami, Gifu, Japan

Countries

Japan

Other Identifiers

LYS-0003

Identifier Type: -

Identifier Source: org_study_id