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

Eisai Co., Ltd.48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease Asthma

Interventions

lysozyme 90 mgDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Mizunami, Gifu, Japan

Outcomes

Primary Outcomes

Change of several inflammatory or biochemical marker concentration in inducted sputum

Time frame: 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)

Secondary Outcomes

Monthly reduction in forced expiratory volume in 1 Second (FEV1)

Time frame: 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)

Data from ClinicalTrials.gov

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