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

Eisai

Status and phase: Completed; Phase 4

Conditions: COPD

Treatments: Drug: Lysozyme hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01645800

LYS-002

Details and patient eligibility

About

The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.

Enrollment: 408 patients

Sex: All

Ages: 20 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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408 participants in 2 patient groups, including a placebo group

Lysozyme hydrochloride

Experimental group

Treatment:

Drug: Lysozyme hydrochloride

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo