Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-29 @ 10:09 AM
Study NCT ID:
NCT06987461
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Use of Non-invasive Ventilation in Bronchial Dilatation Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'epidemiological characteristics of the population with bronchial dilation under long-term NIV', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Reasons for placing under NIV', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Non-invasive ventilation adjustment modalities', 'timeFrame': 'Through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Number of acute exacerbations (according to international recommendations) after initiation of NIV', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Stabilization of respiratory functional tests evolution of FEV1 (%, slope) of PaCO2', 'timeFrame': 'Through study completion, an average of 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchial dilatation disease', 'Non-invasive ventilation', 'efficiency'], 'conditions': ['Bronchial Dilatation Disease', 'Bronchectasie']}, 'descriptionModule': {'briefSummary': 'This is a medical record data collection study. The goal of this non-interventional and retrospective study is to describe the characteristics of the population currently being monitored for bronchial dilatation who have been treated with long-term NIV. This is a study based on data from medical records.\n\nThe assessment criteria will be :\n\n* Epidemiological characteristics of the population with bronchial dilatation on long-term NIV\n* Reasons for initiation of NIV\n* NIV adjustment methods', 'detailedDescription': 'Non-invasive ventilation is a treatment sometimes used for severe severe bronchial dilatation, but to date there are no studies its efficacy.\n\nThe expected results in this context are :\n\n* a description of the characteristics of patients with severe bronchial on non-invasive ventilation (NIV)\n* a better understanding, during NIV management, of the settings used, the tolerance and effectiveness of NIV in reducing exacerbations, hospital admissions and patient mortality.\n* move towards better patient management\n\nData will be extracted from patient medical records and the PMSI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population currently being treated for bronchial dilatation treated with long-term NIV', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over 18 years\n* Predominant diagnosis of bronchiectatic disease, excluding cystic fibrosis, confirmed by computed tomography\n* Introduction of long-term NIV at a given point in the patient's care\n\nExclusion Criteria:\n\n* Patient's opposition to participating in this study\n* Cystic fibrosis\n* Predominant diagnosis of COPD or asthma, traction bronchiectasis, bronchiectasis resulting from focal endobronchial lesion, sarcoidosis or active allergic bronchopulmonary aspergillosis."}, 'identificationModule': {'nctId': 'NCT06987461', 'acronym': 'BRONCHINIV', 'briefTitle': 'Study of the Use of Non-invasive Ventilation in Bronchial Dilatation Disease', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Study of the Use of Non-invasive Ventilation in Bronchial Dilatation Disease (BRONCHINIV)', 'orgStudyIdInfo': {'id': 'BRONCHINIV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with bronchial dilatation treated with non-invasive ventilation', 'description': 'Adult patients with predominantly cystic fibrosis bronchiectatic disease confirmed by tododensitometry, treated with NIV'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Suela DEMIRI, Doctor, Hospital Practitioner', 'role': 'CONTACT', 'email': 'suela.demiri@chicreteil.fr', 'phone': '01 57 02 29 63'}, {'name': 'Suela DEMIRI, Doctor, Hospital Practitioner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Intercommunal de Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94010', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric SCHLEMMER, Lecturer hospital practitioner', 'role': 'CONTACT', 'email': 'frederic.schlemmer@aphp.fr', 'phone': '01 49 81 23 78'}, {'name': 'Frédéric SCHLEMMER, Lecturer hospital practitioner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21000', 'city': 'Dijon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marjolaine GEORGES, Doctor, Hospital Practitioner', 'role': 'CONTACT', 'email': 'marjolaine.georges@chu-dijon.fr', 'phone': '08 90 43 40 86'}, {'name': 'Marjolaine GEORGES, Doctor, Hospital Practitioner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '35000', 'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maria Alejandra GALARZA JIMENEZ, Doctor, Hospital Practitioner', 'role': 'CONTACT', 'email': 'Mariaalejandra.GALARZA.JIMENEZ@chu-rennes.fr', 'phone': '+33 2 99 28 43 21'}, {'name': 'Maria Alejandra GALARZA JIMENEZ, Doctor, Hospital Practitioner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion DUPUIS, Doctor, Hospital Practitioner', 'role': 'CONTACT', 'email': 'dupuis.m@chu-toulouse.fr', 'phone': '+33 5 67 77 18 58'}, {'name': 'Marion DUPUIS, Doctor, Hospital Practitioner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Suela DEMIRI, Doctor, Hospital Practitioner', 'role': 'CONTACT', 'email': 'suela.demiri@chicreteil.fr', 'phone': '01 57 02 29 63'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}