Back to resultsPharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom
Primary Purpose
Chronic Obstructive Pulmonary Disease, Asthma
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
lysozyme 90 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Asthma, Lysozyme Hydrochloride
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lysozyme 90 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change of several inflammatory or biochemical marker concentration in inducted sputum
Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.
Secondary Outcome Measures
Monthly reduction in forced expiratory volume in 1 Second (FEV1)
Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01715493
Brief Title
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom
Official Title
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Asthma
Keywords
COPD, Asthma, Lysozyme Hydrochloride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lysozyme 90 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
lysozyme 90 mg
Other Intervention Name(s)
PRT10T
Intervention Description
Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PRT10T
Intervention Description
Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)
Primary Outcome Measure Information:
Title
Change of several inflammatory or biochemical marker concentration in inducted sputum
Time Frame
8 weeks (2 periods each lasting 4 weeks)
Title
Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.
Time Frame
8 weeks (2 periods each lasting 4 weeks)
Secondary Outcome Measure Information:
Title
Monthly reduction in forced expiratory volume in 1 Second (FEV1)
Time Frame
8 weeks (2 periods each lasting 4 weeks)
Title
Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)
Time Frame
8 weeks (2 periods each lasting 4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Shibata
Organizational Affiliation
Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters
Official's Role
Study Director
Facility Information:
City
Mizunami
State/Province
Gifu
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom
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