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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease, Asthma

Intervention / Treatment
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* Drug: lysozyme 90 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lysozyme 90 mg<br> | Drug: lysozyme 90 mg<br>* Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)<br>* Other names: PRT10T;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)<br>* Other names: PRT10T;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Asthma, Lysozyme Hydrochloride