Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-26 @ 11:51 PM
Study NCT ID:
NCT01196832
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2010-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Fibrocytes in Chronic Obstructive Pulmonary Disease
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2010-06-01', 'studyFirstSubmitQcDate': '2010-09-06', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of circulating blood fibrocytes', 'timeFrame': 'Day 1', 'description': 'Sampling of blood in Chronic obstructive pulmonary disease patients'}, {'measure': 'Number of circulating blood fibrocytes', 'timeFrame': '2 months', 'description': 'Sampling of blood in Chronic obstructive pulmonary disease patients'}], 'secondaryOutcomes': [{'measure': 'Characterization of fibrocytes', 'timeFrame': 'Day 1 and at 2 months', 'description': 'Sampling of blood'}, {'measure': 'Differenciation of blood fibrocytes', 'timeFrame': 'Day 1 and at 2 months', 'description': 'Sampling of blood'}, {'measure': 'Chemotactism of blood fibrocytes', 'timeFrame': 'Day 1 and at 2 months', 'description': 'Sampling of blood'}, {'measure': 'Number of exacerbation', 'timeFrame': '12 months after V2'}, {'measure': 'Mortality', 'timeFrame': '12 months after V2'}, {'measure': 'Annual decline of ventilatory function', 'timeFrame': '12 months after V2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '26602164', 'type': 'DERIVED', 'citation': 'Dupin I, Allard B, Ozier A, Maurat E, Ousova O, Delbrel E, Trian T, Bui HN, Dromer C, Guisset O, Blanchard E, Hilbert G, Vargas F, Thumerel M, Marthan R, Girodet PO, Berger P. Blood fibrocytes are recruited during acute exacerbations of chronic obstructive pulmonary disease through a CXCR4-dependent pathway. J Allergy Clin Immunol. 2016 Apr;137(4):1036-1042.e7. doi: 10.1016/j.jaci.2015.08.043. Epub 2015 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is a frequent airway disease characterized by both bronchial inflammation and remodelling.\n\nBronchial mucosa is infiltrated by macrophages, neutrophils and lymphocytes. In addition, the number of eosinophils can be also increased during exacerbation.\n\nAirway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of COPD and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female aged more than 40 years\n\n* Chronic obstructive pulmonary disease (CODP) patients recruited during hospitalization in Intensive care unit or as outpatients in the clinical investigation centre of the CHU de Bordeaux.\n* Control group: subjects without any history of lung disease and with normal lung function testing recruited following a normal lung function testing in the clinical investigation centre of the CHU de Bordeaux.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients: diagnostic of Chronic obstructive pulmonary disease (COPD) exacerbation.\n* Control group: subjects without any history of lung disease and with normal lung function testing. Subjects will be separated in 2 sub-groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.\n* Written informed consent\n\nExclusion Criteria:\n\n* Subject without any social security or health insurance\n* Asthma, lung fibrosis or idiopathic pulmonary hypertension\n* Chronic viral infections (hepatitis, HIV)'}, 'identificationModule': {'nctId': 'NCT01196832', 'acronym': 'FIREBROB', 'briefTitle': 'Role of Fibrocytes in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Role of Fibrocytes in the Bronchial Remodeling of Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'CHUBX 2010/05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic obstructive pulmonary disease patients', 'description': 'COPD patients with exacerbation will be recruited during hospitalization in Intensive care unit or as outpatients in the clinical investigation centre of the CHU de Bordeaux.\n\nInclusion visit: blood sample for fibrocytes analysis. Second visit 2 months ± 7 days after the exacerbation: clinical and functional evaluation (plethysmography, TLCO, arterial gaz), blood sample for fibrocytes analysis.', 'interventionNames': ['Procedure: blood sample', 'Procedure: Clinical and functional evaluation']}, {'label': 'Control group', 'description': 'Subjects without any history of lung disease and with normal lung function testing', 'interventionNames': ['Procedure: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'PROCEDURE', 'description': 'blood sample for fibrocytes analysis', 'armGroupLabels': ['Chronic obstructive pulmonary disease patients', 'Control group']}, {'name': 'Clinical and functional evaluation', 'type': 'PROCEDURE', 'description': 'Plethysmography, Carbon monoxide capacity of transfer , arterial gaz', 'armGroupLabels': ['Chronic obstructive pulmonary disease patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'overallOfficials': [{'name': 'Patrick BERGER, PUPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Bordeaux (France)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}