Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2026-02-25 @ 7:07 PM
Study NCT ID:
NCT01715493
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2012-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009113', 'term': 'Muramidase'}], 'ancestors': [{'id': 'D006026', 'term': 'Glycoside Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-17', 'studyFirstSubmitDate': '2012-09-10', 'studyFirstSubmitQcDate': '2012-10-24', 'lastUpdatePostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of several inflammatory or biochemical marker concentration in inducted sputum', 'timeFrame': '8 weeks (2 periods each lasting 4 weeks)'}, {'measure': 'Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.', 'timeFrame': '8 weeks (2 periods each lasting 4 weeks)'}], 'secondaryOutcomes': [{'measure': 'Monthly reduction in forced expiratory volume in 1 Second (FEV1)', 'timeFrame': '8 weeks (2 periods each lasting 4 weeks)'}, {'measure': 'Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)', 'timeFrame': '8 weeks (2 periods each lasting 4 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Asthma', 'Lysozyme Hydrochloride'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Asthma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nFor COPD:\n\n* Over 20 years of age and below 85 years of age\n* Smoking history\n* Brinkman index 200 or more\n* Diagnosis of COPD\n* Forced expiratory volume in 1 second (FEV1) of \\<80% of the predicted value\n* Ratio of FEV1 to forced vital capacity (FVC) of \\<70%\n* symptom of expectorated sputum\n\nFor Asthma\n\n* Over 20 years of age and below 85 years of age\n* Scored between 20 to 24 by ACT (Asthma Control Test)\n* Symptom of expectorated sputum\n* Diagnosed partly controlled by global initiative for asthma\n\nExclusion criteria:\n\n* Egg allergy\n* Domiciliary oxygen therapy\n* Pneumonia or pulmonary tuberculosis\n* Patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic disorder, severe hematological disorder\n* Cancer'}, 'identificationModule': {'nctId': 'NCT01715493', 'briefTitle': 'Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'LYS-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lysozyme 90 mg', 'interventionNames': ['Drug: lysozyme 90 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'lysozyme 90 mg', 'type': 'DRUG', 'otherNames': ['PRT10T'], 'description': 'Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)', 'armGroupLabels': ['Lysozyme 90 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['PRT10T'], '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)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mizunami', 'state': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.36667, 'lon': 137.25}}], 'overallOfficials': [{'name': 'Kai Shibata', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}