Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-05 @ 1:06 PM
Study NCT ID:
NCT03646851
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2018-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aspergillus and Chronic Obstructive Pulmonary Disease Evolution
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of aspergillus in sputum or respiratory samples', 'timeFrame': 'one year before inclusion', 'description': 'sputum examination'}], 'secondaryOutcomes': [{'measure': 'Dyspnea with MMRC score', 'timeFrame': 'day of inclusion', 'description': 'Pulmonary function testing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective multicenter cohort study which includes all consecutive COPD patients who come for a visit in one the participating pneumologist. They will have to do a sputum and to complete some questionnaries. Questionnaries will be redone by phone after 1 and 3 months and during the visit after 6 months. We will correlate aspergillus presence in sputum with quality of life (QoL), and COPD symptoms evaluated by questionnaires.', 'detailedDescription': 'Aspergillosis disease is a growing problem. These diseases are not yet uncommon in chronic obstructive pulmonary disease patients. (COPD).\n\nAspergillosis disease are very difficult to be diagnosed or treated. Isolation of aspergillus in sputum of patients is not always responsible of a real disease. Need of treatment is discussed. That is why, we will conduct a prospective cohort study to evaluate aspergillus rate in respiratory samples of COPD patients (GOLD stage III or IV)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients GOLD stage III and IV\n\nExclusion Criteria:\n\n* Cystic fibrosis\n* Pulmonary fibrosis\n* hematological malignancy\n* known aspergilloma\n* allergic bronchopulmonary aspergillosis'}, 'identificationModule': {'nctId': 'NCT03646851', 'acronym': 'AspergBPCO', 'briefTitle': 'Aspergillus and Chronic Obstructive Pulmonary Disease Evolution', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Impact of Aspergillus on Chronic Obstructive Pulmonary Disease Evolution', 'orgStudyIdInfo': {'id': 'PI2017_843_0024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COPD', 'description': 'COPD patients GOLD stage III and IV', 'interventionNames': ['Diagnostic Test: Questionnaries']}], 'interventions': [{'name': 'Questionnaries', 'type': 'DIAGNOSTIC_TEST', 'description': 'patients will have to do a sputum and to complete some questionnaries', 'armGroupLabels': ['COPD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abbeville', 'country': 'France', 'facility': 'CH Abbeville', 'geoPoint': {'lat': 50.10521, 'lon': 1.83547}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Amiens', 'country': 'France', 'facility': "Clinique de l'Europe", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Saint-Quentin', 'country': 'France', 'facility': 'CHU St Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}