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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01715493

Enrollment

Registered

2012-10-29

Start date

2012-10-31

Completion date

2014-01-31

Last updated

2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Chronic Obstructive Pulmonary Disease

Keywords

COPD, Asthma, Lysozyme Hydrochloride

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.

Interventions

DRUGlysozyme 90 mg

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 84 Years

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

Design outcomes

Primary

Measure	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

Measure	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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026