Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-04 @ 8:54 AM
Study NCT ID:
NCT02783768
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2016-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ventilation and Pulmonary Endothelium Toxicities of E-cigarettes: A Randomized Crossover Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}, {'id': 'D005682', 'term': 'Gadolinium'}], 'ancestors': [{'id': 'D028581', 'term': 'Lanthanoid Series Elements'}, {'id': 'D008674', 'term': 'Metals, Rare Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eco7@cumc.columbia.edu', 'phone': '212-305-9056', 'title': 'Elizabeth C. Oelsner, MD, MPH', 'organization': 'CUIMC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '7 days', 'eventGroups': [{'id': 'EG000', 'title': 'E-cigarette First', 'description': 'Participants will undergo the e-cigarette exposure prior to the first two MRI measures, and then they will undergo the sham exposure prior to the last two MRI measures. The two MRIs performed under both experimental exposures (e-cigarette and sham) will be enhanced by (1) gadolinium and then (2) hyperpolarized 3-helium.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham First', 'description': 'Participants will undergo the sham exposure prior to the first two MRI measures, and then they will undergo the e-cigarette exposure prior to the last two MRI measures. The two MRIs performed under both experimental exposures (e-cigarette and sham) will be enhanced by (1) gadolinium and then (2) hyperpolarized 3-helium.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pulmonary Microvascular Blood Flow (PMBF), Measured on Gadolinium-enhanced MRI, Between E-cigarette Exposed and Unexposed Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to E-cigarette', 'description': 'Participants were exposed to a standardized e-cigarette prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}, {'id': 'OG001', 'title': 'Unexposed (Sham)', 'description': 'Participants were exposed to a standardized sham prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.4', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '63.1', 'spread': '19.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.98', 'ciLowerLimit': '4.012', 'ciUpperLimit': '23.94', 'estimateComment': 'Measurements were included for participants with at least one valid MRI measurement.', 'groupDescription': 'Within-person effects of e-cigarette exposure on pulmonary microvascular blood flow (PMBF) was assessed via mixed models accounting for order effects.\n\nNull hypothesis: e-cigarette exposure is NOT associated with a change in PMBF.\n\nAlternative hypothesis: e-cigarette exposure IS associated with a change in PMBF.\n\nPower calculation: not applicable since this was a pilot/feasibility study.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Testing for difference in the outcome measure according to the exposure (which was not a treatment) in a randomized crossover setting.'}], 'paramType': 'MEAN', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'PMBF will be measured on gadolinium-enhanced MRI after e-cigarette and sham exposures. There were four days between the measurements of PMBF (e-cigarette) and PMBF (sham). PMBF is measured in mL(blood)/min/mL(lung volume). Lower PMBF has been observed in adults with COPD and emphysema.', 'unitOfMeasure': 'mL(blood)/min/mL(lung)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) experienced both e-cigarette and sham exposures. In this outcome measure, the same 10 evaluable subjects all had exposure and no exposure at different time periods in the study.'}, {'type': 'PRIMARY', 'title': 'Ventilation Defect Percentage (VDP), Measured on Hyperpolarized 3-helium Enhanced MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to E-cigarette', 'description': 'Participants were exposed to a standardized e-cigarette prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}, {'id': 'OG001', 'title': 'Unexposed (Sham)', 'description': 'Participants were exposed to a standardized sham prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'VDP will be measured on hyperpolarized 3Helium-enhanced MRI after e-cigarette and sham exposures. Due to limitations of prior qualitative/visual assessments of MRI, we developed and validated a new deep learning approach to the precise measurement of ventilation defects and report the percent non-fully ventilated lung using this method.', 'unitOfMeasure': 'percentage of total lung volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of participants were unable to complete the 3-He enhanced MRI due to problems with the helium polarizer and/or scanner (e.g., unable to fit into scanner due to body size). In this outcome measure, 7 out of 11 subjects had evaluable data.'}, {'type': 'SECONDARY', 'title': 'Regional PMBF, Measured on Gadolinium-enhanced MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to E-cigarette', 'description': 'Participants were exposed to a standardized e-cigarette prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}, {'id': 'OG001', 'title': 'Unexposed (Sham)', 'description': 'Participants were exposed to a standardized sham prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}], 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'Regional PMBF (ie, in the right versus left, upper versus lower lobes) will be measured on gadolinium-enhanced MRI after e-cigarette and sham exposures.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not analyzed due to unavailable resources and technology because of the pandemic.'}, {'type': 'SECONDARY', 'title': 'Regional VDP, Measured on Hyperpolarized 3-helium Enhanced MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to E-cigarette', 'description': 'Participants were exposed to a standardized e-cigarette prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}, {'id': 'OG001', 'title': 'Unexposed (Sham)', 'description': 'Participants were exposed to a standardized sham prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'Regional VDP in the lower lung was measured on hyperpolarized 3Helium-enhanced MRI after e-cigarette and sham exposures.', 'unitOfMeasure': 'percentage of total lung volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of participants were unable to complete the 3-He enhanced MRI due to problems with the helium polarizer and/or scanner (e.g., unable to fit into scanner due to body size). In this outcome measure, 7 out of 11 subjects had evaluable data.'}, {'type': 'SECONDARY', 'title': 'Lung Function, Measured on Spirometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to E-cigarette', 'description': 'Participants were exposed to a standardized e-cigarette prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}, {'id': 'OG001', 'title': 'Unexposed (Sham)', 'description': 'Participants were exposed to a standardized sham prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.22', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '4.08', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'Lung function will be measured on spirometry. Two participants had only one valid FEV1 measure, and one participant had no valid FEV1 measures. Hence, 3 participants (2 in "E-cigarette first" and 1 in "Sham first") were not analyzed. The analysis combines the groups in order to separate the effects of randomization group (order) and exposure.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In this outcome measure, 7 out of 11 subjects had evaluable data.'}, {'type': 'SECONDARY', 'title': 'Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to E-cigarette', 'description': 'Participants were exposed to a standardized e-cigarette prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}, {'id': 'OG001', 'title': 'Unexposed (Sham)', 'description': 'Participants were exposed to a standardized sham prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.65', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '32.73', 'spread': '8.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'DLCO will be measured. There was a malfunction of the machine used to measure the DLCO. Hence, only one participant had paired DLCO values and 3 had unpaired measures.', 'unitOfMeasure': 'mL/min/mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In this outcome measure, the machine broke and only 3 subjects had evaluable data for the exposed time period and 2 subjects had evaluable data for the unexposed time period'}, {'type': 'SECONDARY', 'title': 'Cardiac Output, Measured on Cardiac MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed to E-cigarette', 'description': 'Participants were exposed to a standardized e-cigarette prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}, {'id': 'OG001', 'title': 'Unexposed (Sham)', 'description': 'Participants were exposed to a standardized sham prior to MRI measurement of the outcome measure. Since this study applied a randomized crossover design, participants from both randomization groups (exposure first and sham first) are reported in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '6197', 'spread': '1097', 'groupId': 'OG000'}, {'value': '6093', 'spread': '844', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'Cardiac output will be measured on cardiac MRI. In the "E-cigarette first" arm, 2 participants did not have 2 valid measures of CO (one pair was missing, one was invalid). In the "Sham first" arm, 3 participants had one invalid measure of CO. The analysis combines the groups in order to separate the effects of randomization group (order) and exposure.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In this outcome measure, 8 subjects had evaluable data for the exposed time period and 7 subjects had evaluable data for the unexposed time period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'E-cigarette First', 'description': 'Participants will undergo the e-cigarette exposure prior to the first two MRI measures, and then they will undergo the sham exposure prior to the last two MRI measures. The two MRIs performed under both experimental exposures (e-cigarette and sham) will be enhanced by (1) gadolinium and then (2) hyperpolarized 3-helium.'}, {'id': 'FG001', 'title': 'Sham First', 'description': 'Participants will undergo the sham exposure prior to the first two MRI measures, and then they will undergo the e-cigarette exposure prior to the last two MRI measures. The two MRIs performed under both experimental exposures (e-cigarette and sham) will be enhanced by (1) gadolinium and then (2) hyperpolarized 3-helium.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There were a total of 12 subjects enrolled. 6 subjects were randomized to "E-cigarette first," of which 5 completed the full protocol. 5 subjects were randomized to "Sham first," all 5 of whom completed the full protocol. 1 subject was consented but not randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total', 'description': 'This is a randomized crossover study. Participants were randomized to two groups, which differed by order of the exposure to e-cigarette versus sham: (1) e-cigarette first, followed by sham, or (2) sham first, followed by e-cigarette. All participants were both "exposed" and "unexposed."'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'There were a total of 12 subjects enrolled. 6 subjects were randomized to "E-cigarette first," of which 5 completed the full protocol. 5 subjects were randomized to "Sham first," all 5 of whom completed the full protocol. 1 subject was consented but not randomized and is therefore not included/reported in the baseline analysis population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-11', 'size': 246495, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-22T15:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2016-05-24', 'resultsFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-29', 'studyFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Microvascular Blood Flow (PMBF), Measured on Gadolinium-enhanced MRI, Between E-cigarette Exposed and Unexposed Conditions', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'PMBF will be measured on gadolinium-enhanced MRI after e-cigarette and sham exposures. There were four days between the measurements of PMBF (e-cigarette) and PMBF (sham). PMBF is measured in mL(blood)/min/mL(lung volume). Lower PMBF has been observed in adults with COPD and emphysema.'}, {'measure': 'Ventilation Defect Percentage (VDP), Measured on Hyperpolarized 3-helium Enhanced MRI', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'VDP will be measured on hyperpolarized 3Helium-enhanced MRI after e-cigarette and sham exposures. Due to limitations of prior qualitative/visual assessments of MRI, we developed and validated a new deep learning approach to the precise measurement of ventilation defects and report the percent non-fully ventilated lung using this method.'}], 'secondaryOutcomes': [{'measure': 'Regional PMBF, Measured on Gadolinium-enhanced MRI', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'Regional PMBF (ie, in the right versus left, upper versus lower lobes) will be measured on gadolinium-enhanced MRI after e-cigarette and sham exposures.'}, {'measure': 'Regional VDP, Measured on Hyperpolarized 3-helium Enhanced MRI', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'Regional VDP in the lower lung was measured on hyperpolarized 3Helium-enhanced MRI after e-cigarette and sham exposures.'}, {'measure': 'Lung Function, Measured on Spirometry', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'Lung function will be measured on spirometry. Two participants had only one valid FEV1 measure, and one participant had no valid FEV1 measures. Hence, 3 participants (2 in "E-cigarette first" and 1 in "Sham first") were not analyzed. The analysis combines the groups in order to separate the effects of randomization group (order) and exposure.'}, {'measure': 'Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'DLCO will be measured. There was a malfunction of the machine used to measure the DLCO. Hence, only one participant had paired DLCO values and 3 had unpaired measures.'}, {'measure': 'Cardiac Output, Measured on Cardiac MRI', 'timeFrame': 'After exposure (approximately 30 seconds)', 'description': 'Cardiac output will be measured on cardiac MRI. In the "E-cigarette first" arm, 2 participants did not have 2 valid measures of CO (one pair was missing, one was invalid). In the "Sham first" arm, 3 participants had one invalid measure of CO. The analysis combines the groups in order to separate the effects of randomization group (order) and exposure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['E-cigarettes', 'COPD'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'E-cigarettes']}, 'descriptionModule': {'briefSummary': 'Determination of the acute pulmonary toxicities of e-cigarettes in young adults is of major public health importance, as e-cigarette vapor contains established toxicants that as hypothesized cause acute damage to the airways and the pulmonary microvasculature that may promote the development of CLD, for which there remain few effective therapies.\n\nThe study therefore propose a pilot study using a randomized crossover design in ten healthy young adults to test the acute effects of a standardized e-cigarette exposure on two sensitive, safe, non-invasive imaging measures: (1) ventilation defects on hyperpolarized helium-enhanced magnetic resonance imaging, and (2) pulmonary microvascular blood flow on gadolinium-enhanced pulmonary magnetic resonance angiography.', 'detailedDescription': 'Magnetic resonance imaging (MRI) and angiography (MRA) measures are promising approaches to detecting and characterizing the anticipated acute pulmonary toxicities of e-cigarettes. Hyperpolarized helium (3He)-enhanced MRI may be more sensitive than spirometry, a global lung function measure, for determination of airway toxicities. 3He-enhanced MRI has been used to demonstrate the extent of ventilation defects in healthy persons with normal spirometry; to measure ventilation changes in asthmatics pre- and post-challenge with bronchodilators and methacholine; and to predict pulmonary hospitalizations in persons with COPD. Meanwhile, until recently, non-invasive measures of pulmonary vascular toxicities were lacking. The investigators have developed an innovative measure of pulmonary microvascular blood flow on gadolinium (Gd)-enhanced MRA, which the investigators found to be markedly abnormal in early chronic obstructive pulmonary disease (COPD) and emphysema, and to be associated with increased endothelial microparticles, a marker of endothelial dysfunction. Nonetheless, neither of these sensitive, non-invasive, repeatable, and reproducible measures has ever been used to assess e-cigarette toxicities.\n\nIt is hypothesized that e-cigarette vapor inhalation will result in an acute increase in global and regional ventilation defects and an acute decrease in global and regional pulmonary microvascular perfusion.\n\nThis pilot work will provide the experience and data to support subsequent funding applications powered to definitively establish the acute toxicities of e-cigarette vapor of various compositions (e.g., with and without nicotine, with and without flavoring) in persons with and without chronic lung diseases (e.g., asthma) on pulmonary ventilation and microvascular perfusion. Furthermore, confirmation of the hypotheses in this sample would provide important preliminary evidence of e-cigarette pulmonary toxicities to inform interim regulatory decisions, as well as potentially generating vivid images of e-cigarette harms that may be meaningful to the general public and therefore suitable for use in public education campaigns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current use of e-cigarettes (\\>1x/month but \\<4 days/week)\n\nExclusion Criteria:\n\n* any chronic medical or major psychiatric problems including current asthma\n* self-reported heavy snoring/sleep apnea\n* pre-bronchodilator FEV1 or FVC \\<80% predicted or FEV1/FVC \\< lower limit of normal\n* MRI exclusions (pregnancy, claustrophobia, metal in body, gadolinium allergy, eGFR \\<60 mL/min/1.73m2)\n* MRI scan with contrast within the last 12 months or planned MRI with contrast in the next 6 months\n* use of any of the following in the prior 30 days: any conventional cigarettes, marijuana \\>10 days, any illicit drugs, any medication or inhalers (excluding hormonal contraceptives)\n* binge drinking (≥5 alcoholic beverages over 2 hours) over the prior two weeks\n* adverse symptomatic response to the study e-cigarette exposure (e.g., palpitations, shortness of breath, chest pain, headache, dizziness)'}, 'identificationModule': {'nctId': 'NCT02783768', 'acronym': 'VaPE-Tox', 'briefTitle': 'Ventilation and Pulmonary Endothelium Toxicities of E-cigarettes: A Randomized Crossover Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Ventilation and Pulmonary Endothelium Toxicities (VaPE-Tox) of E-cigarettes: A Randomized Crossover Pilot Study', 'orgStudyIdInfo': {'id': 'AAAQ8089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-cigarette first', 'description': 'Participants will undergo the e-cigarette exposure prior to the first two MRI measures, and then they will undergo the sham exposure prior to the last two MRI measures. The two MRIs performed under both experimental exposures (e-cigarette and sham) will be enhanced by (1) gadolinium and then (2) hyperpolarized 3-helium.', 'interventionNames': ['Device: E-cigarette', 'Other: Sham', 'Drug: Hyperpolarized 3-Helium', 'Drug: Gadolinium']}, {'type': 'EXPERIMENTAL', 'label': 'Sham first', 'description': 'Participants will undergo the sham exposure prior to the first two MRI measures, and then they will undergo the e-cigarette exposure prior to the last two MRI measures. The two MRIs performed under both experimental exposures (e-cigarette and sham) will be enhanced by (1) gadolinium and then (2) hyperpolarized 3-helium.', 'interventionNames': ['Device: E-cigarette', 'Other: Sham', 'Drug: Hyperpolarized 3-Helium', 'Drug: Gadolinium']}], 'interventions': [{'name': 'E-cigarette', 'type': 'DEVICE', 'description': 'The study e-cigarette exposure will be 10 puffs with 30-second inter-puff intervals, as directly observed by a trained research assistant, using a standardized e-cigarette. Cartomizers, batteries, and e-liquids will be obtained from commercial suppliers. The e-cigarette device will be loaded with 1 mL of flavorless e-liquid with a ratio of PG to vegetable glycerin of 70:30 and 1.8 mg/dL of nicotine.', 'armGroupLabels': ['E-cigarette first', 'Sham first']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'The "unexposed" condition will be breathing from the study e-cigarette (10 puffs with 30-second inter-puff intervals) with the battery off.', 'armGroupLabels': ['E-cigarette first', 'Sham first']}, {'name': 'Hyperpolarized 3-Helium', 'type': 'DRUG', 'otherNames': ['3-He'], 'description': 'Hyperpolarized 3-Helium will be used as an experimental contrast agent for the Ventilation MRIs performed twice per participant in both experimental arms. Approximately 250-600 mL of hyperpolarized 3He mixed with 300-750 mL nitrogen will be inhaled through a one-way valve in one inhalation starting approximately at residual volume.', 'armGroupLabels': ['E-cigarette first', 'Sham first']}, {'name': 'Gadolinium', 'type': 'DRUG', 'otherNames': ['Gd'], 'description': 'Gadolinium contrast will be injected into the antecubital vein through an 18-20 gauge IV. The type of gadolinium will be 0.03 mmol/kg bodyweight of dotarem (gadoterate meglumine).', 'armGroupLabels': ['E-cigarette first', 'Sham first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Elizabeth Oelsner, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Elizabeth Oelsner', 'investigatorAffiliation': 'Columbia University'}}}}