Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-06 @ 7:37 AM
Study NCT ID:
NCT04142827
Status:
UNKNOWN
Last Update Posted:
2019-10-29
First Post:
2019-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-09-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-10-25', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvment Daily Life', 'timeFrame': '1 year', 'description': 'measurement via questionary SGRQ'}, {'measure': 'measurement of Sputum production', 'timeFrame': '1 year', 'description': 'Microbiological Mesurement of sputum'}, {'measure': 'measurement Exercise tolerance', 'timeFrame': '1 year', 'description': 'measurement with 6 minutes walking test'}, {'measure': 'Number of missed working or school day', 'timeFrame': '1 year', 'description': 'Calculation of days of sick'}, {'measure': 'time from first exacerbations', 'timeFrame': '1 year', 'description': 'measurement of time dalay from last exacerbation'}, {'measure': 'number of exacerbations including their durations and severity', 'timeFrame': '1 year', 'description': 'counting form their clinic diary of number of exacerbation'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Arterial Blood Glass', 'timeFrame': '1 year', 'description': 'Arterial Blood Glass draw at time zero and time 1'}, {'measure': 'Unit of Nitric Oxide', 'timeFrame': '1 year', 'description': 'Measurement with Nitric oxide device'}, {'measure': 'Evaluation of Reactive C-Protein', 'timeFrame': '1 year', 'description': 'comparation of blood draw'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bronchiectasis', 'High Flow Therapy', 'Humidifcation', 'Lung Infection', 'Quality of life'], 'conditions': ['Bronchiectasis Adult', 'Lung Infection', 'Quality of Life', 'Humidifier Lung', 'COPD Exacerbation', 'COPD Asthma']}, 'descriptionModule': {'briefSummary': 'The study is intended to understand the benefit of Long Term Home care Therapy with nasal High flow in Bronchiectasis patients at home. Primary end point is to evaluate daily life compared to usual care and secondary is to evaluate the changes in lung function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Bronchiectasis on HRCT\n* Optimization of Therapy for at least 15 days before enrollment\n* Autonomous patients with possibilities of practicing rehabilitations cycles\n\nExclusion Criteria:\n\n* OSAS (ODI\\>10/h)\n* HOME NIV\n* PH\\<7,35 - paO2\\< 60mmHg, paCo2\\> 55 mmHg\n* Lung cancer\n* Contraindication to high-flow nasal cannula (hfnc)'}, 'identificationModule': {'nctId': 'NCT04142827', 'acronym': 'BX', 'briefTitle': 'The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)', 'organization': {'class': 'OTHER', 'fullName': 'Monaldi Hospital'}, 'officialTitle': 'The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care', 'orgStudyIdInfo': {'id': 'High Flow in Bronchiectasis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapy with high flow humidification', 'description': 'The patients will be activated after enrollment with myAirvo2 device at home for 6 months before first observations', 'interventionNames': ['Device: High Flow Humidification']}, {'type': 'NO_INTERVENTION', 'label': 'Therapy with usual care', 'description': 'The patients will be under usual care for observational'}], 'interventions': [{'name': 'High Flow Humidification', 'type': 'DEVICE', 'description': 'myAirvo2 gives at home for long therapy treatment', 'armGroupLabels': ['Therapy with high flow humidification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rosa Cauteruccio, Doctor', 'role': 'CONTACT', 'email': 'rosacauteruccio@gmail.com', 'phone': '+393392193620'}], 'facility': 'Rosa Cauteruccio', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'centralContacts': [{'name': 'Giuseppe Fiorentino, Doctor', 'role': 'CONTACT', 'email': 'giuseppefiorentino1@gmail.com', 'phone': '+393478482564'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Giuseppe Fiorentino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director Giuseppe Fiorentino', 'investigatorFullName': 'Dr. Giuseppe Fiorentino', 'investigatorAffiliation': 'Monaldi Hospital'}}}}