- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01715493
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom
July 17, 2014 updated by: Eisai Co., Ltd.
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study
The aim of this study was to assess the effectiveness for small airway inflammation of 4 weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gifu
-
Mizunami, Gifu, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 84 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
For COPD:
- Over 20 years of age and below 85 years of age
- Smoking history
- Brinkman index 200 or more
- Diagnosis of COPD
- Forced expiratory volume in 1 second (FEV1) of <80% of the predicted value
- Ratio of FEV1 to forced vital capacity (FVC) of <70%
- symptom of expectorated sputum
For Asthma
- Over 20 years of age and below 85 years of age
- Scored between 20 to 24 by ACT (Asthma Control Test)
- Symptom of expectorated sputum
- Diagnosed partly controlled by global initiative for asthma
Exclusion criteria:
- Egg allergy
- Domiciliary oxygen therapy
- Pneumonia or pulmonary tuberculosis
- Patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic disorder, severe hematological disorder
- Cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)
Other Names:
|
Experimental: Lysozyme 90 mg
|
Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of several inflammatory or biochemical marker concentration in inducted sputum
Time Frame: 8 weeks (2 periods each lasting 4 weeks)
|
8 weeks (2 periods each lasting 4 weeks)
|
Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.
Time Frame: 8 weeks (2 periods each lasting 4 weeks)
|
8 weeks (2 periods each lasting 4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Monthly reduction in forced expiratory volume in 1 Second (FEV1)
Time Frame: 8 weeks (2 periods each lasting 4 weeks)
|
8 weeks (2 periods each lasting 4 weeks)
|
Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)
Time Frame: 8 weeks (2 periods each lasting 4 weeks)
|
8 weeks (2 periods each lasting 4 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kai Shibata, Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
September 10, 2012
First Submitted That Met QC Criteria
October 24, 2012
First Posted (Estimate)
October 29, 2012
Study Record Updates
Last Update Posted (Estimate)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 17, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LYS-0003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Mylan Inc.Theravance BiopharmaCompletedChronic Obstructive Pulmonary Disease (COPD)United States
-
University Hospital, GhentGlaxoSmithKline; University GhentCompletedChronic Obstructive Pulmonary Disease (COPD)Belgium
-
Optimum Patient CareRespiratory Effectiveness Group; Boehringer Ingelheim Pharmaceutical Company... and other collaboratorsUnknownChronic Obstructive Pulmonary Disease (13645005)United States
-
Poitiers University HospitalCompletedBroncho Chronic Obstructive Pulmonary DiseaseFrance
Clinical Trials on lysozyme 90 mg
-
AlbionSprim Advanced Life SciencesUnknown
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingDiarrhea | Wasting | Malnutrition, ChildKenya
-
ShireTerminatedSanfilippo SyndromeNetherlands, United Kingdom
-
Laboratorios Andromaco S.A.Completed
-
Centocor Research & Development, Inc.CompletedPsoriasisUnited States, United Kingdom, Germany, Canada, Austria, France, Switzerland
-
Janssen Research & Development, LLCCompletedCrohn's Disease | Colitis | Inflammatory Bowel Disease | IBDUnited States, France, Poland, United Kingdom, Germany, Spain, Israel, Bulgaria, Serbia, South Africa, Japan, Canada, Australia, Netherlands, Korea, Republic of, Belgium, New Zealand, Brazil, Russian Federation, Austria, Hungary, ... and more
-
CelltrionTerminatedInfluenza AKorea, Republic of
-
Renibus Therapeutics, Inc.Terminated
-
PrileniaCompletedHealth Volunteers, Huntington DiseaseGermany
-
AmgenCompletedPostmenopausal OsteoporosisUnited States, Poland, Czechia