Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-26 @ 11:03 AM
Study NCT ID:
NCT01617369
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2012-06-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Characterize the Durability of Hypertonic Saline to Enhance Mucociliary Clearance in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'scott_donaldson@med.unc.edu', 'phone': '919-966-9198', 'title': 'Dr. Scott Donaldson', 'organization': 'University of North Carolina Chapel Hill'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Acute Hypertonic Saline Effect', 'description': '2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured.\n\nHypertonic Saline: 2.8% NaCl x 4ml via nebulizer', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sustained Hypertonic Saline Effect', 'description': '2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured.\n\nHypertonic Saline: 2.8% NaCl x 4ml via nebulizer', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Whole Lung Mucociliary Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Hypertonic Saline Effect', 'description': '2.8% NaCl inhaled 30 minutes before MCC scan performed\n\nHypertonic Saline: 2.8% NaCl x 4ml via Pari LC STAR jet nebulizer'}, {'id': 'OG001', 'title': 'Sustained Hypertonic Saline Effect', 'description': '2.8% NaCl Inhaled 4 hours before mucociliary clearance measured\n\nHypertonic saline = 2.8% NaCl x 4 ml delivered via Pari LC STAR jet nebulizer'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Paired t-test performed. Null hypothesis is that no difference in clearance 30 min and 4 hr after HS inhalation exists', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes and 4 hours after inhalation', 'description': 'The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes.\n\nAbsolute change in MCC-Ave90 from baseline reported for each arm', 'unitOfMeasure': '% Clearance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hypertonic Saline', 'description': '2.8% NaCl\n\nHypertonic Saline: 2.8% NaCl x 4ml via nebulizer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hypertonic Saline', 'description': '2.8% NaCl\n\nHypertonic Saline: 2.8% NaCl x 4ml via nebulizer'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '43'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'East Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'West Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other, Specify', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current Smoker', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Healthy subjects of any ethnicity between 18-55 years of age, without respiratory or cardiac comorbidities, FEV1 greater than or equal to 80% predicted, FEV1/FVC ratio greater than 70%, non-pregnant female subjects, and subjects who are capable of providing their written informed consent.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects completed mucociliary clearance measurements (via gamma scintigraphy) at baseline, 30 minutes after inhaling 2.8% NaCl, and 4 hours after inhaling 2.8% NaCl at separate study visits to characterize acute vs. sustained effects of inhaled 2.8% NaCl on this physiologic process.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2012-06-06', 'resultsFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2012-06-11', 'lastUpdatePostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-15', 'studyFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Whole Lung Mucociliary Clearance', 'timeFrame': '30 minutes and 4 hours after inhalation', 'description': 'The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes.\n\nAbsolute change in MCC-Ave90 from baseline reported for each arm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to learn about how long hypertonic saline (HS) works in healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up in the lungs. Hypertonic saline and other medications currently being developed may help patients with these lung diseases by speeding up mucus clearance from the lung. For these treatments to be effective, they likely need to be able to act for at lease several hours. Investigators are able to measure how lung treatments like hypertonic saline work by conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how long hypertonic saline works in people who do not have CF. Investigators plan to use this information to improve the design and testing of new treatments for patients with chronic bronchitis.\n\nObjectives:\n\n1. The investigators will use MCC measurements to determine the durability of action of hypertonic saline in healthy (i.e. non-CF) subjects.\n2. The investigators will determine the intra- and inter-individual variability of baseline MCC measurements using a slow inhalation/large particle protocol in healthy subjects to guide future sample size calculations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects, without respiratory or cardiac comorbidities\n* Age 18-55 years, inclusive\n* FEV1 \\> 80% predicted and FEV1/FVC ratio \\>70%\n* Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or, must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation\n* Subjects who are capable of providing their written informed consent to participate in the study\n\nExclusion Criteria:\n\n* History of smoking \\> 10 pack-years\n* Any history of smoking within 60 days of screening\n* Acute upper or lower respiratory illness within 30 days of screening\n* Respiratory medication for any indication within 30 days of screening\n* History of asthma, chronic bronchitis, or other chronic lung disease\n* History of intolerance to hypertonic saline\n* Women who are pregnant, lactating, or of childbearing potential who are unwilling to use an acceptable method of contraception throughout the duration of the study.\n* Any condition that, in the opinion of the investigator, would potentially jeopardize the safety of the participant or the integrity of the study\n* History of radiation exposure within the past year that would cause the subject to exceed limits for adults established by Federal Regulations\n* Subjects who, in the opinion of the Principal Investigator, should not participate in the study'}, 'identificationModule': {'nctId': 'NCT01617369', 'briefTitle': 'Study to Characterize the Durability of Hypertonic Saline to Enhance Mucociliary Clearance in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'A Study to Characterize the Durability of Hypertonic Saline for the Enhancement of Mucociliary Clearance in Healthy Subjects', 'orgStudyIdInfo': {'id': '11-1932'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute Hypertonic Saline Effect', 'description': '2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured.', 'interventionNames': ['Device: Hypertonic Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sustained Hypertonic Saline Effect', 'description': '2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured.', 'interventionNames': ['Device: Hypertonic Saline']}], 'interventions': [{'name': 'Hypertonic Saline', 'type': 'DEVICE', 'description': '2.8% NaCl x 4ml via nebulizer', 'armGroupLabels': ['Acute Hypertonic Saline Effect', 'Sustained Hypertonic Saline Effect']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Scott Donaldson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Scott Donaldson, MD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}