Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT04878367
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2021-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'COPD without intervention group , with intervention group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SGRQ-C', 'timeFrame': '12 months', 'description': 'Quality of life'}, {'measure': 'CAT', 'timeFrame': '12 months', 'description': 'Quality of life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '39251997', 'type': 'DERIVED', 'citation': 'Ji HW, Kang J, Kim HC, Jung J, Lee SJ, Jung JY, Lee SW. The association between cumulative exposure to PM2.5 and DNA methylation measured using methyl-capture sequencing among COPD patients. Respir Res. 2024 Sep 9;25(1):335. doi: 10.1186/s12931-024-02955-3.'}, {'pmid': '37918066', 'type': 'DERIVED', 'citation': 'Kang J, Kim HC, Jang Y, Lee JB, Lee JS, Oh YM, Ji HW, Jung JY, Lee SW. Randomised controlled trial of a behavioural intervention to reduce exposure to PM2.5 in patients with COPD. Environ Int. 2023 Nov;181:108286. doi: 10.1016/j.envint.2023.108286. Epub 2023 Oct 24.'}, {'pmid': '34889270', 'type': 'DERIVED', 'citation': 'Kang J, Jung JY, Huh JY, Ji HW, Kim HC, Lee SW. Behavioral interventions to reduce particulate matter exposure in patients with COPD. Medicine (Baltimore). 2021 Dec 10;100(49):e28119. doi: 10.1097/MD.0000000000028119.'}]}, 'descriptionModule': {'briefSummary': 'It is a prospective, multi-institutional clinical study and targets patients diagnosed with chronic obstructive pulmonary disease. About 120 subjects (35 at Ilsan Paik Hospital, 35 at Severance Hospital, and 50 at Asan Medical Center in Seoul) will be subject to a random allocation of 1:1. The arbitration group implements living rules for responding to fine dust, supports air purifiers, and only general guidance is implemented in the non-property group. Patients are recruited from Asan Medical Center in Seoul (Songpa-gu, Seoul), Severance Hospital ( Seodaemun-gu, Seoul), and Ilsan Paik Medical Center (Goyang, Gyeonggi-do) for 12 months. During outpatient visits, lung function tests and airway resistance tests shall be conducted, and surveys presented in the research plan shall be conducted.', 'detailedDescription': "It is a prospective and multi-institutional clinical study targeting patients with chronic obstructive pulmonary disease in general.\n\nA total of 120 COPD patients will be recruited from three institutions: Asan Medical Center, Severance Hospital, and Ilsan Paik Hospital. (60/30/30 expected) A panel of COPD patients is established to conduct prospective studies, and measures to mediate recurrence and deterioration of adult chronic respiratory diseases due to exposure to fine dust are presented. Improvement of the lifestyle of the arbitration forces. Detailed research methods such as air purifier support are presented in the research plan.\n\nIn addition, a fine dust measurement researcher visits each household to measure indoor fine dust concentration. The measurement method of fine dust concentration will be using the process test method, IoT-based sensors, and direct-to-read measuring devices to measure Air Korea's air pollution. Detailed visit timing and methods are carried out in the manner specified in the research plan.\n\nWe collect sputum at every visit and blood at the last visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 40 years of age or older\n* Waste function test results show FEV1/FVC\\<0.7, FEV1 \\<80% of forecast\n\nExclusion Criteria:\n\n* Patients under 18 years of age with changes in medication (such as inhalants).\n* Older people over 80 years of age.\n* People with no respiratory symptoms with mMRC 0.\n* Who doesn't understand a simple explanation for fine dust exposure devices.\n* Someone who disagrees with the study."}, 'identificationModule': {'nctId': 'NCT04878367', 'briefTitle': 'Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD', 'orgStudyIdInfo': {'id': '2021-0956'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COPD_E', 'description': 'COPD patients with intervention', 'interventionNames': ['Behavioral: Five active practices of living rules for responding to fine dust.']}, {'type': 'NO_INTERVENTION', 'label': 'COPD_C', 'description': 'COPD patients without intervention'}], 'interventions': [{'name': 'Five active practices of living rules for responding to fine dust.', 'type': 'BEHAVIORAL', 'description': '1. Check the fine dust weather forecast\n2. Check the operation time and filter of the air purifier\n3. Window ventilation\n4. Inhalant is used or not\n5. Bad fine dust: Refrain from going out', 'armGroupLabels': ['COPD_E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sei won Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul Asan Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data are available at the time of the analysis of the results after the clinical study.', 'ipdSharing': 'YES', 'description': 'The resident registration number may be used when requesting data from the National Statistical Office or the Health Review and Assessment Service for future research analysis and data collection.', 'accessCriteria': 'Gender, age, smoking power and address are collected anonymously.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Sei Won Lee', 'investigatorAffiliation': 'Asan Medical Center'}}}}