Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-11 @ 7:00 AM
Study NCT ID:
NCT03187860
Status:
TERMINATED
Last Update Posted:
2023-06-12
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012907', 'term': 'Smoking'}], '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'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Inclusions was stopped at 30 patients. Investigators did not wish to extend inclusions.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-08', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-06-12', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surface density of active cilia', 'timeFrame': 'Day 0 + approximately 2 months of cell culture time', 'description': 'Surface density of active cilia'}], 'secondaryOutcomes': [{'measure': 'Cilia beating frequency', 'timeFrame': 'Day 0 + approximately 2 months of cell culture time', 'description': 'The frequency at which cilia beat.'}, {'measure': 'Mucus viscosity', 'timeFrame': 'Day 0 + approximately 2 months of cell culture time', 'description': 'The viscosity of mucus produced by cell cultures.'}, {'measure': 'Mucus elasticity', 'timeFrame': 'Day 0 + approximately 2 months of cell culture time', 'description': 'The elasticity of mucus produced by cell cultures.'}, {'measure': 'Cilia beat orientation', 'timeFrame': 'Day 0 + approximately 2 months of cell culture time', 'description': 'The direction in which cilia beat'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bronchial epithelial cell', 'mucus', 'Air Liquid Interface'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'Asthma', 'Smoking']}, 'descriptionModule': {'briefSummary': 'This is a prospective study comparing 4 groups: (1) non-smoking controls, (2) smokers without chronic obstructive pulmonary disease (COPD), (3) smokers with COPD, (4) severe asthma.\n\nBronchial biopsy specimens from each subject will be obtained to produce air-liquid-interface cell cultures. These will then be used to make observations concerning cilia and mucus rheology.\n\nThis is a first pilot study. The working hypothesis is that the largest group differences will be found for cilia densities; the latter metric was thus chosen as a primary criterion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria for non smoking controls:\n\n* The subject has given free and informed consent and signed the consent form\n* The subject is affiliated with or beneficiary of a medical insurance program\n* The subject has never smoked\n* No obstructive breathing disorder (forced expiratory volume at one second (FEV1) \\>70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is \\> 0.7)\n* No known respiratory disease\n\nInclusion criteria for smokers without COPD:\n\n* The subject has given free and informed consent and signed the consent form\n* The subject is affiliated with or beneficiary of a medical insurance program\n* Smoker or former smoker (\\>= 30 pack years)\n* No obstructive breathing disorder (forced expiratory volume at one second (FEV1) \\>70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is \\> 0.7)\n\nInclusion criteria for smokers with COPD:\n\n* The subject has given free and informed consent and signed the consent form\n* The subject is affiliated with or beneficiary of a medical insurance program\n* Smoker or former smoker (\\>= 30 pack years)\n* Subject presenting with COPD: FEV1/FVC \\< 0.7 (based on spirometry values in the medical file and performed in the 3 months prior to inclusion)\n* The subject requires bronchial fibroscopy (decision made by pneumologist)\n* COPD of grade "2" or "3" according to GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)\n\nInclusion criteria for subjects with severe asthma:\n\n* The subject has given free and informed consent and signed the consent form\n* The subject is affiliated with or beneficiary of a medical insurance program\n* Non-smoker or former smoker (\\<10 pack years)\n* Subject presenting with severe asthma: FEV1/FVC \\>= 0.7 and FEV1 \\< 80%\n* The subjects requires bronchial fibroscopy (decision made by pneumologist)\n\nExclusion criteria:\n\n* The subject has an extensive neoplastic disease\n* The subject has another active lung disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection)\n* The subject has had a recent psychiatric disorder (within one year prior to inclusion and documented by a specialist consultation)\n* Emergency situations (object extractions...)\n* Subject consuming illicit drugs or alcohol\n* The subject is in an exclusion period determined by a previous study\n* The subject is under judicial protection, or is an adult under any kind of guardianship\n* It is impossible to correctly inform the patient\n* The subject cannot fluently read French'}, 'identificationModule': {'nctId': 'NCT03187860', 'acronym': 'RhéMuc', 'briefTitle': 'Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Demonstration of the Diagnostic Character of the Rheology of Mucus', 'orgStudyIdInfo': {'id': 'RECHMPL18_0222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-smoking controls', 'description': 'Subjects in this group have never smoked and have no known lung disorders.\n\nIntervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)', 'interventionNames': ['Procedure: Bronchial Biopsy', 'Other: ALI culture']}, {'type': 'EXPERIMENTAL', 'label': 'Smokers without COPD', 'description': 'Subjects in this group are smokers or former smokers who do not have signs of obstructive disease (no chronic obstructive pulmonary disease (COPD))\n\nIntervention: Bronchial Biopsy + ALI culture', 'interventionNames': ['Procedure: Bronchial Biopsy', 'Other: ALI culture']}, {'type': 'EXPERIMENTAL', 'label': 'Smokers with COPD', 'description': 'Subjects in this group are smokers or former smokers who have COPD\n\nIntervention: Bronchial Biopsy + ALI culture', 'interventionNames': ['Procedure: Bronchial Biopsy', 'Other: ALI culture']}, {'type': 'EXPERIMENTAL', 'label': 'Severe asthma', 'description': 'Subjects in this group are non-smokers or former (light) smokers who have severe asthma.\n\nIntervention: Bronchial Biopsy + ALI culture', 'interventionNames': ['Procedure: Bronchial Biopsy', 'Other: ALI culture']}], 'interventions': [{'name': 'Bronchial Biopsy', 'type': 'PROCEDURE', 'description': 'Bronchial biopsies will be performed on all subjects.', 'armGroupLabels': ['Non-smoking controls', 'Severe asthma', 'Smokers with COPD', 'Smokers without COPD']}, {'name': 'ALI culture', 'type': 'OTHER', 'description': 'Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.', 'armGroupLabels': ['Non-smoking controls', 'Severe asthma', 'Smokers with COPD', 'Smokers without COPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Anne Sophie Gamez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Montpellier University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}