Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT03447418
Status:
UNKNOWN
Last Update Posted:
2021-01-27
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Breath Nitrogen Washout in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 191}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Clearance Index 2.5% (LCI 2.5%) Value', 'timeFrame': 'hour 1', 'description': "Multiple breath washout is a pulmonary function test that does not require patients' cooperation. It studies the number of lung volumes (turn-over) to clear a gaz such as nitrogen form the lungs. LCI 2,5 is most frequently reported outcome measure. It corresponds to the sum of the total expired lung volumes needed to decrease the initial gaz concretion to its 1/40th, divided by functional residual capacity.\n\nLCI can be measured in infant, preschoolers and thereafter. In order to obtain reproducible tests, three acceptable maneuvers are needed."}], 'secondaryOutcomes': [{'measure': 'Lung Clearance Index 5% (LCI 5%) Value', 'timeFrame': 'hour 1'}, {'measure': 'Moment ratio M1/M0 Value', 'timeFrame': 'up to 1 hour'}, {'measure': 'Moment ratio M0/M2 Value', 'timeFrame': 'up to 1 hour'}, {'measure': 'Sacin value', 'timeFrame': 'hour 1', 'description': 'assessment of distal areas function'}, {'measure': 'Scond value', 'timeFrame': 'hour 1', 'description': 'assessment of conductive areas function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Clearance Index', 'Breath Nitrogen Washout', 'Healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent by participant, parent, or legal guardian\n* Healthy subjects with a social insurance\n\nExclusion Criteria:\n\n* History of a lung chronic disease\n* Premature birth (\\<37th weeks of amenorrhea)\n* Acute lower respiratory viral infection within 3 weeks before Multiple Breath washout'}, 'identificationModule': {'nctId': 'NCT03447418', 'acronym': 'HV-LCI', 'briefTitle': 'Multiple Breath Nitrogen Washout in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Multiple Breath Nitrogen Washout in Healthy Volunteers', 'orgStudyIdInfo': {'id': '69HCL18_0064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'no treatment, open label', 'interventionNames': ['Procedure: Multiple breath nitrogen washout']}], 'interventions': [{'name': 'Multiple breath nitrogen washout', 'type': 'PROCEDURE', 'description': 'Lung Clearance Index (LCI) will be performed in healthy volunteers with a multiple breath nitrogen washout device.', 'armGroupLabels': ['no treatment, open label']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe REIX, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Philippe REIX, Pr', 'role': 'CONTACT', 'email': 'philippe.reix@chu-lyon.fr', 'phone': '427 85 54 70', 'phoneExt': '+33'}, {'name': 'Marie PERCEVAL', 'role': 'CONTACT', 'email': 'marie.perceval@chu-lyon.fr', 'phone': '427 85 59 87', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}