Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-01-08 @ 4:31 AM
Study NCT ID:
NCT04005833
Status:
TERMINATED
Last Update Posted:
2024-08-23
First Post:
2019-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With COPD in Primary Care.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013147', 'term': 'Spirometry'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Specific to research: the determination of fibrocytes on EDTA tubes (with Ethylenediaminetetraacetic acid) The samples will be transported fresh to measure the rate of circulating blood fibrocytes by flow cytometry.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Inclusions were suspended due to the COVID-19 pandemic, and the inclusion rate would not increase during the resumption.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2019-02-15', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of blood fibrocytes', 'timeFrame': 'Day 1', 'description': 'blood fibrocytes level measured during the suspected exacerbation'}, {'measure': 'Forced Expiratory Volume (FEV)', 'timeFrame': 'month 36', 'description': 'FEV1 assessed by spirometry'}], 'secondaryOutcomes': [{'measure': 'Forced Expiratory Volume (FEV)', 'timeFrame': 'month 2', 'description': 'FEV1 assessed by spirometry'}, {'measure': 'Forced Expiratory Volume (FEV)', 'timeFrame': 'month 12', 'description': 'FEV1 assessed by spirometry'}, {'measure': 'Score of modified Medical Research Council dyspnea scale', 'timeFrame': 'month 2', 'description': 'The MMRC dyspnea scale is a standardized questionnaire validated and measuring the degree of dyspnea in patients with COPD. The scale is an ordinal variable into 5 classes from 0 to 4, a score of 4 representing a major dyspnea.'}, {'measure': 'Score of modified Medical Research Council dyspnea scale', 'timeFrame': 'month 12', 'description': 'The MMRC dyspnea scale is a standardized questionnaire validated and measuring the degree of dyspnea in patients with COPD. The scale is an ordinal variable into 5 classes from 0 to 4, a score of 4 representing a major dyspnea.'}, {'measure': 'Score of modified Medical Research Council dyspnea scale', 'timeFrame': 'month 36', 'description': 'The MMRC dyspnea scale is a standardized questionnaire validated and measuring the degree of dyspnea in patients with COPD. The scale is an ordinal variable into 5 classes from 0 to 4, a score of 4 representing a major dyspnea.'}, {'measure': 'Score of Chronic obstructive pulmonary disease Assessment Test', 'timeFrame': 'month 2', 'description': 'health status measured by CAT (http://www.catestonline.org/english/index\\_France.htm)'}, {'measure': 'Score of Chronic obstructive pulmonary disease Assessment Test', 'timeFrame': 'month 12', 'description': 'health status measured by CAT (http://www.catestonline.org/english/index\\_France.htm)'}, {'measure': 'Score of Chronic obstructive pulmonary disease Assessment Test', 'timeFrame': 'month 36', 'description': 'health status measured by CAT (http://www.catestonline.org/english/index\\_France.htm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary disease', 'chronic obstructive', 'Primary Health Care', 'Fibrocyte', 'Respiratory Function Tests'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to estimate the association between blood fibrocytes measured during a suspected exacerbation and 3-year decline forced expiratory volume in one second (FEV1), in patients with Chronic obstructive pulmonary disease (COPD) in primary care, with a history of smoking, independently of the number of exacerbations and of tobacco or occupational exposure.', 'detailedDescription': "COPD is highly prevalent in primary care. It is associated with tobacco smoke or toxic occupational exposure. Some COPD patients will experience a faster decline in quality of life and lung function. There is currently no prognostic marker allowing to identify those patients at higher risk of fast lung function decline. Recent data suggest that fibrocytes are involved in COPD's physiopathology. A higher blood fibrocytes level during an acute exacerbation has been associated with higher mortality in COPD patients at a late stage of the disease. In mice, fibrocytes role in lung function decline has been demonstrated at an early stage. To date, association between blood fibrocytes during an exacerbation and lung function decline has not been evaluated at the early stage of COPD in humans.\n\nThis study aims to estimate the association between blood fibrocytes measured during a suspected exacerbation and 3-year decline in forced expiratory volume in one second (FEV1), in patients with COPD in primary care, with a history of smoking, independently of the number of exacerbations and of tobacco or occupational exposure.\n\nIn this study, blood fibrocytes during a suspected exacerbation will be measured at inclusion. The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion. COPD-related health status and severity of dyspnea will be assessed with COPD Assessment test (CAT) and the modified Medical Research Council dyspnea scale (mMRC) at follow-up visits at 2 months, 12 months and 36 months after inclusion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Man or woman aged more than 40 years old with tobacco exposure of more than 20 pack-years, Presenting to a General Practitioner with a suspected mild or moderate COPD exacerbation according to GOLD guidelines (worsening of symptoms with the need for prescribing short acting bronchodilatators, antibiotics or oral corticosteroids).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* man or woman aged more than 40 years old,\n* with tobacco exposure of more than 20 pack-years,\n* Presenting to a General Practitioner with a suspected mild or moderate COPD exacerbation according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (worsening of symptoms with the need for prescribing short acting bronchodilatators, antibiotics or oral corticosteroids)\n* Informed consent given\n* Affiliated to a social insurance scheme\n\nExclusion Criteria:\n\n* Severe exacerbation of COPD according to GOLD guidelines (patient requires hospitalization or visits to the emergency room),\n* More likely differential diagnosis than a COPD exacerbation, such as pneumonia, acute pulmonary oedema or other differential diagnosis,\n* history of asthma, pulmonary fibrosis, primary pulmonary hypertension or chronic viral infections (HIV, hepatitis)\n* person under care or protection of vulnerable adults'}, 'identificationModule': {'nctId': 'NCT04005833', 'acronym': 'FIBRO-COPD', 'briefTitle': 'Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With COPD in Primary Care.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Association Between Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD) in Primary Care', 'orgStudyIdInfo': {'id': 'CHUBX 2017/43'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD exacerbation', 'description': 'COPD exacerbation, compared according to blood fibrocytes level measured during the suspected exacerbation (Day 1)', 'interventionNames': ['Diagnostic Test: spirometry']}], 'interventions': [{'name': 'spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion.', 'armGroupLabels': ['COPD exacerbation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33830', 'city': 'Belin-Béliet', 'country': 'France', 'facility': 'Cabinet médical', 'geoPoint': {'lat': 44.5, 'lon': -0.78333}}, {'zip': '33410', 'city': 'Cadillac', 'country': 'France', 'facility': 'Cabinet Médical', 'geoPoint': {'lat': 44.63641, 'lon': -0.31855}}], 'overallOfficials': [{'name': 'Emmanuel Prothon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bordeaux'}, {'name': 'Patrick Berger, MD/PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital University, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}