Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT01713335
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2012-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proteasis Evaluation in 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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-25', 'studyFirstSubmitDate': '2012-10-15', 'studyFirstSubmitQcDate': '2012-10-22', 'lastUpdatePostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kallikrein level in sputum by ELISA', 'timeFrame': 'One sample at inclusion'}], 'secondaryOutcomes': [{'measure': 'Comparison between kallikrein level and clinical or functionnal parameters', 'timeFrame': 'All data will be identified at inclusion', 'description': 'Correlation between kallikrein and FEV1 Correlation between kallikrein and dyspnea score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients. Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be included: Healthy smoker subjects, stable COPD patients and COPD patients with acute exacerbation. Kallicrein levels in sputum will be compared in these groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stable COPD patients were recruited from pulmonary primary care of pulmonary division of CHRU of Tours.\n\nCOPD with acute exacerbation were recruited from hospitalisation of pulmonary division of CHRU of Tours and intensive care unit of CHRU of Tours.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for healthy subjects:\n\n* Smoker with tobacco consumption of 20 pack/year\n* Normal lung function tests\n\nExclusion Criteria for healthy subjects:\n\n* diagnosis of lung disease during the study\n* Asthma\n* Lung cancer\n* Pregnant and lactating women\n\nInclusion Criteria for stable COPD:\n\n* Smoker with tobacco consumption of 20 pack/year\n* FEV1/FVC\\<70% on lung function tests\n* no hospitalisation for exacerbation during 3 months before inclusion\n\nExclusion Criteria for stable COPD:\n\n* Asthma\n* Lung cancer\n* Pregnant and lactating women\n\nInclusion Criteria for COPD with exacerbation:\n\n* Smoker with tobacco consumption of 20 pack/year\n* worsening of pulmonary symptoms\n* FEV1/FVC\\<70% on lung function tests could be obtain before or 3 months after exacerbation\n\nExclusion Criteria for COPD with exacerbation:\n\n* Asthma\n* Lung cancer\n* Pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT01713335', 'acronym': 'Pro-BPCO', 'briefTitle': 'Proteasis Evaluation in COPD', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Proteasis Evaluation in COPD', 'orgStudyIdInfo': {'id': 'C11-56'}, 'secondaryIdInfos': [{'id': '2012-A00885-38', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tours', 'country': 'France', 'facility': 'CHRU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Laurent Guilleminault, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Pneumologie, CHRU Tours, Tours, France'}, {'name': 'Valérie Gissot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre d'Investigation Clinique, CHRU Tours, Tours, France"}, {'name': 'Antoine Guillon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Réanimation médicale, CHRU Tours, Tours, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}