Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2026-01-09 @ 6:43 PM
Study NCT ID:
NCT03079661
Status:
TERMINATED
Last Update Posted:
2020-07-15
First Post:
2017-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Air Quality on Exacerbations of COPD in the Somme
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'investigator choice', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exacerbation rate : variable to be explicated with explicative variable : ozone, particles, dioxide nitrogen, but also pollens corresponding to each patient home address for period of exacerbation', 'timeFrame': '1 day', 'description': 'exacerbation rate : variable to be explicated with explicative variable : ozone, particles, dioxide nitrogen, but also pollens corresponding to each patient home address for period of exacerbation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pollution', 'ozone', 'Copd', 'particles'], 'conditions': ['Acute Exacerbation Copd']}, 'referencesModule': {'references': [{'pmid': '39614356', 'type': 'DERIVED', 'citation': 'Basille D, Soriot L, Weppe F, Desmettres P, Henriques P, Benoit N, Devaux S, Diouf M, Jounieaux V, Andrejak C. Association between acute exacerbation of chronic obstructive pulmonary disease and short-term exposure to ambient air pollutants in France. Environ Health. 2024 Nov 29;23(1):107. doi: 10.1186/s12940-024-01146-3.'}]}, 'descriptionModule': {'briefSummary': 'All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie between 01/01/2017 and 31/12/2017. The investigator will collect for each patient the home address and the work address. The duration of 1 year was chosen to take into account seasonal variations. In parallel, a daily report of the rate of ozone, particles (PM2.5 and PM10), dioxide nitrogen but also odours and pollens will be done by ATMO Picardie.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The primary endpoint is the number of exacerbations of COPD corresponding to the variable of interest to be explained. The other variables are the explanatory variables (air quality data PM2.5, PM10, NO2, O3 as well as pollen data, seasonal variations, influenza epidemic and olfactory nuisance). The final diagnosis will also be collected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All COPD patients with a diagnosis of acute exacerbation of COPD in the emergency room. The definition of COPD and acute exacerbation are the official definition of the Société de Pneumologie en Langue Française.\n\nExclusion Criteria:\n\n* no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT03079661', 'acronym': 'PolluBPCO', 'briefTitle': 'Impact of Air Quality on Exacerbations of COPD in the Somme', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Impact of Air Quality on Exacerbations of COPD in the Somme', 'orgStudyIdInfo': {'id': 'RNI2016-42'}}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'country': 'France', 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}