CompletedNCT01645800Updated Oct 21, 2015

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

A Phase 4 interventional study of Lysozyme hydrochloride and Placebo in COPD, sponsored by Eisai Co., Ltd.. Completed at 25 sites in Japan. Open to participants aged 20 Years to 84 Years. Per ClinicalTrials.gov, last updated 2015-10-21.

Sponsored by Eisai Co., Ltd. · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 408
Allocation: Randomized
Ages: 20 Years to 84 Years
Sex: All

Study summary

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

Conditions studied

COPD

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Keywords

Lysozyme hydrochloride
COPD

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 408 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 84 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 408 participants (actual)

Study arms

Experimental
Lysozyme hydrochloride
Drug: Lysozyme hydrochloride
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugLysozyme hydrochloride
LYL 90mg capsule: Three times daily for 52 weeks.
DrugPlacebo
Matching Placebo capsule: Three times daily for 52 weeks.

What researchers measure

Primary outcomes

Acute exacerbation of COPD
Time frame: 52 weeks

Secondary outcomes

Yearly reduction in FEV1 and QOL assessed by CAT
Time frame: 52 weeks

Study locations

25 sites

Nishio, Aichi, Japan
Noda, Chiba, Japan
Kasuga, Fukuoka, Japan
Kyoto-gun, Fukuoka, Japan
Yanagawa, Fukuoka, Japan
Mabashi, Gunma, Japan
Takasaki, Gunma, Japan
Kitahiroshima, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Himeji, Hyogo, Japan
Takamatsu, Kagawa, Japan
Yokohama, Kanagawa, Japan
Yokosuka, Kanagawa, Japan
Nagaoka, Niigata, Japan
Okayama, Okyama, Japan
Suita, Osaka, Japan
Chuo-ku, Tokyo, Japan
Edogawa-ku, Tokyo, Japan
Higashikurume, Tokyo, Japan
Koto-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Fukuoka, Japan
Oita, Japan
Osaka, Japan
Yamagata, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01645800
Lead sponsor: Eisai Co., Ltd.
Responsible party: Sponsor
First posted: Jul 20, 2012
Start date: Aug 2012
Primary completion: Jan 2015
Completion: Mar 2015
Last update: Oct 21, 2015

Study contacts

Yukinori Sakata

study director · Drug Fostering and evolution Coodination Department, Corporate Regulattory Compliance, Safety and Quality Assurance Headquaters, Eisai Co., Ltd., Japan

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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