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

Phase 4

Completed

• Conditions: COPD
• Interventions: Drug: Lysozyme hydrochloride; Drug: Placebo

• Registration Number: NCT01645800
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-20
• Study Start: 2012-08
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lysozyme hydrochloride	Lysozyme hydrochloride	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Acute exacerbation of COPD	52 weeks

Secondary Outcome Measures

Name	Time	Method
Yearly reduction in FEV1 and QOL assessed by CAT	52 weeks