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

Eisai

Status and phase: Completed; Phase 4

Conditions: Asthma; Chronic Obstructive Pulmonary Disease

Treatments: Drug: lysozyme 90 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01715493

LYS-0003

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 20 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Lysozyme 90 mg

Experimental group

Treatment:

Drug: lysozyme 90 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo