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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715493
• Other study ID #: LYS-0003
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2012
• Last updated: July 17, 2014
• Start date: October 2012
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 84 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of several inflammatory or biochemical marker concentration in inducted sputum		8 weeks (2 periods each lasting 4 weeks)	No
Primary	Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.		8 weeks (2 periods each lasting 4 weeks)	No
Secondary	Monthly reduction in forced expiratory volume in 1 Second (FEV1)		8 weeks (2 periods each lasting 4 weeks)	No
Secondary	Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)		8 weeks (2 periods each lasting 4 weeks)	No