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

NCT01715493 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-07-18

No results posted yet for this study

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

Interventions

DRUG

lysozyme 90 mg

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

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)

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01715493 on ClinicalTrials.gov