Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study

COPD Clinical Trial

Official title:

Effects of Lysozyme On Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645800
• Other study ID #: LYS-002
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2012
• Last updated: October 20, 2015
• Start date: August 2012
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• 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 is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 84 Years

Eligibility

Inclusion criteria;

• Patients were eligible for inclusion in the study if they were over 20 years of age and below 85 years of age, and had a smoking history, a diagnosis of COPD, a ratio of FEV1 to forced vital capacity(FVC) of less than 70%, and a documented history of at least one exacerbation leading to any treatment within the previous year.

Exclusion criteria;

• Patients with egg allergy

• Patients with domiciliary oxygen therapy

• Patients with pneumonia or pulmonary tuberculosis

• Patients with severe cardiovascular disorder,severe kidney disorder, severe hepatic disorder, severe hematological disorder.

• Patients with cancer.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Lysozyme hydrochloride
LYL 90mg capsule: Three times daily for 52 weeks.
• Placebo
Matching Placebo capsule: Three times daily for 52 weeks.

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	Acute exacerbation of COPD		52 weeks	No
Secondary	Yearly reduction in FEV1 and QOL assessed by CAT		52 weeks	No