Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT03700892
Status:
TERMINATED
Last Update Posted:
2021-06-10
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
In-vivo Effects of E-cigarette Aerosol on Innate Lung Host Defense
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robinet@med.unc.edu', 'phone': '919 966-5638', 'title': 'Assistant Director of Clinical Research', 'organization': 'University of North Carolina at Chapel Hill, Center for Environmental Medicine Asthma and Lung Biology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the time a participant signed consent through completion of the second intervention, a total of up to 3 months.', 'description': 'Adverse event data included all participants who received at least one dose of Cinnamaldehyde (CA) or Propylene Glycol/Vegetable Glycerin (PG/VG).', 'eventGroups': [{'id': 'EG000', 'title': 'Cinnamaldehyde', 'description': 'Participants who inhaled cinnamaldehyde e-liquid in either Period 1 or Period 2 as per randomization schedule.\n\nCinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PG/VG', 'description': 'Participants who inhaled Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in either Period 1 or Period 2 as per randomization schedule.\n\nPG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Healthy Controls', 'description': 'Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CA-induced Changes in Whole Lung MCC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinnamaldehyde', 'description': 'Participants will inhale cinnamaldehyde e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.\n\nCinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).'}, {'id': 'OG001', 'title': 'PG/VG', 'description': 'Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.\n\nPG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '5', 'groupId': 'OG000'}, {'value': '27', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Absolute values of whole lung MCC at baseline compared to after CA vaping session. Absolute repeat values of Whole lung MCC = average % mucus cleared from the whole lung over a 90-minute period.', 'unitOfMeasure': 'percent clearance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The healthy control participants only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group. This Primary outcome does not apply to the healthy control group as they did not receive the intervention and only baseline data was collected.'}, {'type': 'SECONDARY', 'title': 'CA-induced Changes in Regional Lung MCC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinnamaldehyde', 'description': 'Participants will inhale cinnamaldehyde e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.\n\nCinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).'}, {'id': 'OG001', 'title': 'PG/VG', 'description': 'Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.\n\nPG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).'}], 'classes': [{'title': 'Central Lung', 'categories': [{'measurements': [{'value': '43', 'spread': '12', 'groupId': 'OG000'}, {'value': '25', 'spread': '32', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral Lung', 'categories': [{'measurements': [{'value': '33', 'spread': '3', 'groupId': 'OG000'}, {'value': '24', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Absolute repeat values of Central and Peripheral lung MCC = average % mucus cleared from the Central and Peripheral lung over a 90-minute period. This will assess clearance rates from the central (C) and peripheral (P) regions as secondary endpoints that may reflect differential effects between a region with relatively more (C) vs. less (P) large bronchial airways.', 'unitOfMeasure': 'percent clearance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Polymorphonuclear Leukocytes (PMN) in Induced Sputum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinnamaldehyde', 'description': 'Participants will inhale cinnamaldehyde e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.\n\nCinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).'}, {'id': 'OG001', 'title': 'PG/VG', 'description': 'Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.\n\nPG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '89.4', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change of PMNs in vapers from baseline compared to post CA vaping session. Percent change in PMNs in vapers from baseline compared to post PG/VG vaping session are included as an additional comparison.', 'unitOfMeasure': 'percent PMN', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The healthy control participants only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group. This outcome does not apply to the healthy control group as they did not receive the intervention and only baseline data was collected.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Whole Lung MCC for Each Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-cigarette Users', 'description': 'Baseline MCC scans and sputum collection performed prior to randomization.'}, {'id': 'OG001', 'title': 'Non-smoker/Non-vaper Healthy Controls', 'description': 'Baseline MCC scans and sputum collection.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '8', 'groupId': 'OG000'}, {'value': '14', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Start of study, up to three months', 'description': 'Baseline Differences in Whole lung MCC clearance rates in Non-smokers/Non-vapers as Compared to E-cigarette Users. Absolute group values of Whole Lung MCC =average % mucus cleared from the whole lung over a 90-minute period.', 'unitOfMeasure': 'percent clearance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who completed the baseline MCC scan.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CA-Induced Changes in Immune Cell Function', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change from baseline in phagocytosis', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Peripheral Blood Mononuclear Cell Analysis', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change in cell counts as compared to baseline', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blood Serum Analysis of Inflammatory Mediators', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change of mediator expression as compared to baseline', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CA-Induced Changes in Epithelial Lining Fluid', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Pre-vaping session versus post-vaping session expressed as a percent change', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CA-Induced Changes in Epithelial Lining Fluid 24 Hours After Vaping Session', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change as compared to post-vaping session sample', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Epithelial Lining Fluid', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change as compared to baseline', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tidal Volume Subjects Own E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Tidal Volume in milliliters', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Respiratory Rate With Subjects Own E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Respiratory Rate in breaths per minute', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minute Ventilation With Subjects Own E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Minute Ventilation in L/min', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inspiratory Flow With Subjects Own E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Inspiratory flow in L/min', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Expiratory Flow With Subjects Own E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Expiratory flow in L/min', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tidal Volume With Investigator E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Tidal Volume in milliliters', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Respiratory Rate With Investigator E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Respiratory Rate in breaths per minute', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minute Ventilation With Investigator E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Minute Ventilation in L/min', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inspiratory Flow With Investigator E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Inspiratory flow in L/min', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Expiratory Flow With Investigator E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Expiratory flow in L/min', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cinnamaldehyde, Then PG/VG', 'description': 'Participants will inhale cinnamaldehyde(CA) e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour.\n\nCinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).\n\nPG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).'}, {'id': 'FG001', 'title': 'PG/VG, Then Cinnamaldehyde', 'description': 'Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale cinnamaldehyde e-liquid in 6, 5-minute vaping segments (1 puff/minute) over 1 hour.\n\nCinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).\n\nPG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).'}, {'id': 'FG002', 'title': 'Healthy Controls', 'description': 'Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group.'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'First Intervention (Single 1-Day Visit)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout (2-3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (Single 1-Day Visit)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After qualifying, all participants move to the baseline day in which an mucociliary clearance (MCC) scan and sputum are collected for baseline measurements. The vaping participants continue on to the crossover design for CA and PG/VG sessions followed by MCC scans and sputum collections for post exposure measurements.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'All Treated Participants', 'description': 'All participants inhaled cinnamaldehyde e-liquid or Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in either Period 1 or Period 2 as per randomization schedule.\n\nCinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).\n\nPG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).'}, {'id': 'BG001', 'title': 'Healthy Controls', 'description': 'Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-15', 'size': 515657, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-22T12:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The e-liquids will be maintained by an individual not active in the study procedures or analysis.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Controls will not be randomized and will not receive the study intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Covid-19 has been shown to increase risk associated with vaping. To increase participant safety and use real world vaping habits, the investigators plan to continue studying vaping effects on the airways in an observational format.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2018-10-04', 'resultsFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2018-10-05', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-14', 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'CA-Induced Changes in Immune Cell Function', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change from baseline in phagocytosis'}, {'measure': 'Peripheral Blood Mononuclear Cell Analysis', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change in cell counts as compared to baseline'}, {'measure': 'Blood Serum Analysis of Inflammatory Mediators', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change of mediator expression as compared to baseline'}, {'measure': 'CA-Induced Changes in Epithelial Lining Fluid', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Pre-vaping session versus post-vaping session expressed as a percent change'}, {'measure': 'CA-Induced Changes in Epithelial Lining Fluid 24 Hours After Vaping Session', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change as compared to post-vaping session sample'}, {'measure': 'Changes in Epithelial Lining Fluid', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change as compared to baseline'}, {'measure': 'Tidal Volume Subjects Own E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Tidal Volume in milliliters'}, {'measure': 'Respiratory Rate With Subjects Own E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Respiratory Rate in breaths per minute'}, {'measure': 'Minute Ventilation With Subjects Own E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Minute Ventilation in L/min'}, {'measure': 'Inspiratory Flow With Subjects Own E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Inspiratory flow in L/min'}, {'measure': 'Expiratory Flow With Subjects Own E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Expiratory flow in L/min'}, {'measure': 'Tidal Volume With Investigator E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Tidal Volume in milliliters'}, {'measure': 'Respiratory Rate With Investigator E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Respiratory Rate in breaths per minute'}, {'measure': 'Minute Ventilation With Investigator E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Minute Ventilation in L/min'}, {'measure': 'Inspiratory Flow With Investigator E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Inspiratory flow in L/min'}, {'measure': 'Expiratory Flow With Investigator E-cigarette Device', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Expiratory flow in L/min'}], 'primaryOutcomes': [{'measure': 'CA-induced Changes in Whole Lung MCC', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Absolute values of whole lung MCC at baseline compared to after CA vaping session. Absolute repeat values of Whole lung MCC = average % mucus cleared from the whole lung over a 90-minute period.'}], 'secondaryOutcomes': [{'measure': 'CA-induced Changes in Regional Lung MCC', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Absolute repeat values of Central and Peripheral lung MCC = average % mucus cleared from the Central and Peripheral lung over a 90-minute period. This will assess clearance rates from the central (C) and peripheral (P) regions as secondary endpoints that may reflect differential effects between a region with relatively more (C) vs. less (P) large bronchial airways.'}, {'measure': 'Percent Polymorphonuclear Leukocytes (PMN) in Induced Sputum', 'timeFrame': 'Through study completion, an average of three months', 'description': 'Percent change of PMNs in vapers from baseline compared to post CA vaping session. Percent change in PMNs in vapers from baseline compared to post PG/VG vaping session are included as an additional comparison.'}, {'measure': 'Absolute Values of Whole Lung MCC for Each Group', 'timeFrame': 'Start of study, up to three months', 'description': 'Baseline Differences in Whole lung MCC clearance rates in Non-smokers/Non-vapers as Compared to E-cigarette Users. Absolute group values of Whole Lung MCC =average % mucus cleared from the whole lung over a 90-minute period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['e-cig', 'E-cigarette', 'Electronic cigarette', 'Vaping'], 'conditions': ['Smoking', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '38687136', 'type': 'DERIVED', 'citation': 'Bennett WD, Clapp PW, Zeman KL, Wu J, Ring B, Jaspers I. Acute Effect of E-Cigarette Inhalation on Mucociliary Clearance in E-Cigarette Users. J Aerosol Med Pulm Drug Deliv. 2024 Aug;37(4):167-170. doi: 10.1089/jamp.2023.0027. Epub 2024 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'While e-cigs are commonly represented as safer alternatives to tobacco cigarettes, little is known regarding the health effects of their short- or long-term use. The responses and the e-cig components exerting these effects on the airways are largely unknown. This study will identify if specific e-cig flavors modify respiratory immune responses. This study will determine the effects of cinnamaldehyde (CA)-containing e-cigarettes on airway epithelial cell ciliary function (i.e., MCC) in humans. Additionally the study will determine the effects of CA-containing e-cigarettes on airway immune cells obtained through induced sputum (SI) after inhalation of CA-containing e-cig aerosols to determine CA-induced effects on a) immune cell function (e.g., phagocytosis, respiratory burst), b) immune cell surface phenotype, and c) mediator production in humans in vivo.', 'detailedDescription': 'Investigators will evaluate the acute effect of CA-flavored e-cigs on MCC and IS immune cells in up to 32 healthy, young adults who are current e-cig users with a total of less than 10 pack-years cigarette smoking history. MCC will be measured by gamma scintigraphy at baseline and following controlled vaping of e-liquids with and without cinnamon flavoring. Two different e-liquids (one completely devoid and one containing at least 30 mM CA similar to "Hot Cinnamon Candies" which is commercially available) will be used for two separate randomized vaping sessions.\n\nThe randomization scheme for the two different e-liquids (e-liquids with and without CA) will be generated by using the Web site Randomization.com (http://www.randomization.com), assigned treatment Regimen A and B by an assigned study team member, and provided to the study team. This individual will also be responsible for loading the e-cigarette with the appropriate solution for that session prior to the vaping sessions.\n\nParticipants will undergo baseline testing during the screening visit, which will occur 2-3 weeks prior to the first controlled vaping session. Investigators will also recruit non-vaping control subjects (n=32), who will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group. will aim to recruit similar numbers of males and females in both cohorts. While investigators cannot guarantee age-matching and sex-matching in these cohorts, based on our previous studies, investigators do not expect to find significant age and sex differences in the two cohort. In addition, potential confounders, such as age, sex, and BMI will be included as covariates in our multivariate analysis.\n\nObservations obtained from the non-vaping control group will provide necessary information on potential baseline differences in the two cohorts (i.e. current vapers versus non-vaping controls). These data from the non-vaping control group are important to provide a reference for any potential CA-induced changes in the vaping group. Hence, there are two stages of the study:\n\nStage 1. A cross sectional observational cohort comparison of baseline MCC and IS immune cells in a reference cohort of n=32 non-vaping control subjects and E-cig cohort of n=32 currently vaping subjects (confounding based on other variables such as BMI, sex, age is possible for this stage).\n\nStage 2. A randomized comparison of changes in MCC and IS immune cells after Regimen A (e-cig us without CA) and Regimen B (e-cig use with CA). The cohort of e-cig users will undergo a randomized 2-treatment, 2-period, 2-sequence crossover study of CA exposure.\n\nFor stage 1, baseline measurements of Tc99m-SC clearance will be used to measure each subject\'s normal baseline MCC and IS immune cell characteristics. For both stages, subjects will be asked to complete a vaping diary to record information on the device and e-liquids (name/vendor/e-liquids/puffs/device settings) used during their normal vaping sessions for the entire duration of the study. In addition, for stage 2, participants will be asked to maintain their current habits for the duration of the study, not to significantly increase or decrease their vaping patterns, including the nicotine concentrations of their e-liquids.\n\nFor stage 2, for each e-cig vaping session (Training and MCC Test Days), subjects will be asked to follow a laboratory-based protocol involving 6, 5-minute paced vaping segments (1 puff/minute) over a 1 hour time period, vaping the e-liquid with and without CA provided by us. On each Test Day, participants will undergo the vaping protocol immediately prior to inhalation of the Tc99m-SC (10 min between end of vaping and inhalation of Tc99m-SC). An initial deposition scan of Tc99m-SC will then be obtained followed by dynamic imaging of the lung with subjects seated in front of the gamma camera to determine potential changes in MCC induced by acute exposure to CA-flavored e- cigarettes. Induced sputum samples will be collected at baseline, and after each MCC scan.\n\n24 hours after completion of the MCC scans. The two randomized vaping sessions will be separated by 2-3 weeks. While there are no data providing specific information on the duration needed to washout the effects of CA on MCC, previous studies examining changes in MCC following inhalation of other aerosols have shown that this washout period is sufficient to prevent potential carryover between the two treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An equal number of participants who currently use a vaping device and those who do not use a vaping device\n* Age 18-40\n* Must have a Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV₁) of at least 80% of predicted. Participants who fall out of the normal range will be offered a copy of the test to share with their personal physician.\n\nExclusion Criteria:\n\n* Any pre-existing lung disease (asthma, cystic fibrosis, etc.)\n* Any significant chronic illness, such as, but not limited to, heart disease, uncontrolled hypertension, diabetes, auto-immune disease\n* Any use of tobacco products (other than e-cig) in the past 3 months, or a greater than 10 pack year history of smoking cigarettes\n* Pregnant or nursing women\n* Participants with a history of radiation exposure in the past year which exceeds annual safe limits.'}, 'identificationModule': {'nctId': 'NCT03700892', 'acronym': 'Cinimic', 'briefTitle': 'In-vivo Effects of E-cigarette Aerosol on Innate Lung Host Defense', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'In-vivo Effects of E-cigarette Aerosol on Innate Lung Host Defense', 'orgStudyIdInfo': {'id': '17-2275'}, 'secondaryIdInfos': [{'id': 'R01HL139369', 'link': 'https://reporter.nih.gov/quickSearch/R01HL139369', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cinnamaldehyde, then PG/VG', 'description': 'Participants will inhale cinnamaldehyde e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour.', 'interventionNames': ['Other: Cinnamaldehyde e-liquid', 'Other: PG/VG e-liquid']}, {'type': 'EXPERIMENTAL', 'label': 'PG/VG, then Cinnamaldehyde', 'description': 'Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale cinnamaldehyde e-liquid in 6, 5-minute vaping segments (1 puff/minute) over 1 hour.', 'interventionNames': ['Other: Cinnamaldehyde e-liquid', 'Other: PG/VG e-liquid']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Controls', 'description': 'Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group.'}], 'interventions': [{'name': 'Cinnamaldehyde e-liquid', 'type': 'OTHER', 'otherNames': ['Cinnamon'], 'description': 'Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).', 'armGroupLabels': ['Cinnamaldehyde, then PG/VG', 'PG/VG, then Cinnamaldehyde']}, {'name': 'PG/VG e-liquid', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).', 'armGroupLabels': ['Cinnamaldehyde, then PG/VG', 'PG/VG, then Cinnamaldehyde']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7310', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Center for Environmental Medicine, Asthma and Lung Biology', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Ilona Jaspers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.\n\nProposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University\'s data warehouse but without investigator support other than deposited metadata\n\nRequests for access to individual participant data should be sent to bring44@email.unc.edu or carole.robinette@med.unc.edu. Access will be granted after a data access agreement has been signed with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}