Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-18 @ 6:28 PM
Study NCT ID:
NCT01877304
Status:
COMPLETED
Last Update Posted:
2013-06-13
First Post:
2013-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Drug Targeting Nebulization on Lung Deposition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-10', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung deposition by scintigraphy', 'timeFrame': 'After 15 minutes'}], 'secondaryOutcomes': [{'measure': 'Regional deposition by scintigraphy', 'timeFrame': 'After 15 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'To compare deposition between two modalities of nebulization'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Free of respiratory disease\n\nExclusion Criteria:\n\n* Smokers'}, 'identificationModule': {'nctId': 'NCT01877304', 'briefTitle': 'Effect of Drug Targeting Nebulization on Lung Deposition', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Effect of Drug Targeting Nebulization on Lung Deposition', 'orgStudyIdInfo': {'id': 'AKITA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AKITA with program central deposition', 'description': 'Nebulization for central deposition', 'interventionNames': ['Device: AKITA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AKITA with program for peripheral deposition', 'description': 'Nebulization for peripheral deposition', 'interventionNames': ['Device: AKITA']}], 'interventions': [{'name': 'AKITA', 'type': 'DEVICE', 'armGroupLabels': ['AKITA with program central deposition', 'AKITA with program for peripheral deposition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}