Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
Effects of Lysozyme On Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
1 other identifier
interventional
408
1 country
25
Brief Summary
The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2012
Typical duration for phase_4
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedOctober 21, 2015
October 1, 2015
2.4 years
July 18, 2012
October 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute exacerbation of COPD
52 weeks
Secondary Outcomes (1)
Yearly reduction in FEV1 and QOL assessed by CAT
52 weeks
Study Arms (2)
Lysozyme hydrochloride
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (25)
Unknown Facility
Nishio, Aichi-ken, Japan
Unknown Facility
Noda, Chiba, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Kasuga, Fukuoka, Japan
Unknown Facility
Kyoto-gun, Fukuoka, Japan
Unknown Facility
Yanagawa, Fukuoka, Japan
Unknown Facility
Mabashi, Gunma, Japan
Unknown Facility
Takasaki, Gunma, Japan
Unknown Facility
Kitahiroshima, Hokkaido, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Himeji, Hyōgo, Japan
Unknown Facility
Takamatsu, Kagawa-ken, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Yokosuka, Kanagawa, Japan
Unknown Facility
Nagaoka, Niigata, Japan
Unknown Facility
Ōita, Oita Prefecture, Japan
Unknown Facility
Okayama, Okyama, Japan
Unknown Facility
Osaka, Osaka, Japan
Unknown Facility
Suita, Osaka, Japan
Unknown Facility
Chuo-ku, Tokyo, Japan
Unknown Facility
Edogawa-ku, Tokyo, Japan
Unknown Facility
Higashikurume, Tokyo, Japan
Unknown Facility
Koto-ku, Tokyo, Japan
Unknown Facility
Setagaya-ku, Tokyo, Japan
Unknown Facility
Yamagata, Yamagata, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yukinori Sakata
Drug Fostering and evolution Coodination Department, Corporate Regulattory Compliance, Safety and Quality Assurance Headquaters, Eisai Co., Ltd., Japan
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2012
First Posted
July 20, 2012
Study Start
August 1, 2012
Primary Completion
January 1, 2015
Study Completion
March 1, 2015
Last Updated
October 21, 2015
Record last verified: 2015-10