Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT04430634
Status:
COMPLETED
Last Update Posted:
2021-06-07
First Post:
2020-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paul.morris@nerudia.com', 'phone': '+44 7508 708 917', 'title': 'Paul Morris', 'organization': 'Nerudia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 days', 'eventGroups': [{'id': 'EG000', 'title': 'Product Variant A', 'description': 'MyBlu e-cigarette variant A (2.4% nicotine)', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Product Variant B', 'description': 'MyBlu e-cigarette variant B (3.6% nicotine)', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 4, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Product Variant C', 'description': 'MyBlu e-cigarette variant C (2.5% nicotine)', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 3, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Product Variant D', 'description': 'MyBlu e-cigarette variant D (4.0% nicotine)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Product Variant E', 'description': 'MyBlu e-cigarette variant E (3.6% nicotine)', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 3, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Product Variant F', 'description': 'MyBlu e-cigarette variant F (2.4% nicotine)', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 2, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Product Variant G', 'description': 'MyBlu e-cigarette variant G (4.0% nicotine)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Product Variant H', 'description': 'MyBlu e-cigarette variant H (3.6% nicotine)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Eyelid irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Eyelid pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Swelling of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Throat tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA® Version 22.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Nicotine Concentration in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Product Variant A', 'description': 'MyBlu e-cigarette variant A (2.4% nicotine)'}, {'id': 'OG001', 'title': 'Product Variant B', 'description': 'MyBlu e-cigarette variant B (3.6% nicotine)'}, {'id': 'OG002', 'title': 'Product Variant C', 'description': 'MyBlu e-cigarette variant C (2.5% nicotine)'}, {'id': 'OG003', 'title': 'Product Variant D', 'description': 'MyBlu e-cigarette variant D (4.0% nicotine)'}, {'id': 'OG004', 'title': 'Product Variant E', 'description': 'MyBlu e-cigarette variant E (3.6% nicotine)'}, {'id': 'OG005', 'title': 'Product Variant F', 'description': 'MyBlu e-cigarette variant F (2.4% nicotine)'}, {'id': 'OG006', 'title': 'Product Variant G', 'description': 'MyBlu e-cigarette variant G (4.0% nicotine)'}, {'id': 'OG007', 'title': 'Product Variant H', 'description': 'MyBlu e-cigarette variant H (3.6% nicotine)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '91.6', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '109.6', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '113.5', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '106.4', 'groupId': 'OG003'}, {'value': '6.5', 'spread': '135.7', 'groupId': 'OG004'}, {'value': '4.6', 'spread': '143.4', 'groupId': 'OG005'}, {'value': '8.0', 'spread': '99.6', 'groupId': 'OG006'}, {'value': '9.3', 'spread': '95.8', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)', 'description': 'Maximum nicotine concentration in blood (Cmax)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Concentration of Carboxyhemoglobin in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exclusive MyBlu E-cigarette Use', 'description': 'Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.25', 'spread': '2.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 days', 'description': 'Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.', 'unitOfMeasure': '% saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.'}, {'type': 'PRIMARY', 'title': 'Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exclusive MyBlu E-cigarette Use', 'description': 'Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '345.4', 'spread': '252.3', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-262.8', 'spread': '205.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 days', 'description': 'Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), excreted in urine during 24 hours (creatinine adjusted).', 'unitOfMeasure': 'ng/g creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.'}, {'type': 'PRIMARY', 'title': 'Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exclusive MyBlu E-cigarette Use', 'description': 'Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1242.2', 'spread': '536.0', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1097.1', 'spread': '522.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 days', 'description': 'Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA), a biomarker of exposure to acrolein, excreted in urine during 24 hours (creatinine adjusted).', 'unitOfMeasure': 'ug/g creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.'}, {'type': 'PRIMARY', 'title': 'Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exclusive MyBlu E-cigarette Use', 'description': 'Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '4.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 days', 'description': 'Change from baseline in the amount of S-phenyl mercapturic acid (S-PMA), a biomarker of exposure to benzene, excreted in urine during 24 hours (creatinine adjusted).', 'unitOfMeasure': 'ug/g creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.'}, {'type': 'SECONDARY', 'title': 'Level of White Blood Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exclusive MyBlu E-cigarette Use', 'description': 'Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 days', 'description': 'The change from baseline in the level of white blood cells, a biomarker of potential harm.', 'unitOfMeasure': 'cells*10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.'}, {'type': 'SECONDARY', 'title': 'Spirometry: Forced Expiratory Volume in 1 Second', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exclusive MyBlu E-cigarette Use', 'description': 'Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': '8 days timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 days', 'description': 'Forced expiratory volume in 1 second (FEV1) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.'}, {'type': 'SECONDARY', 'title': 'Spirometry: Forced Vital Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exclusive MyBlu E-cigarette Use', 'description': 'Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)'}], 'classes': [{'title': 'Baseline value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': '8 days timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 days', 'description': 'Forced vital capacity (FVC) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.'}, {'type': 'SECONDARY', 'title': 'Subjective Measure: Urge to Smoke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Product Variant A', 'description': 'MyBlu e-cigarette variant A (2.4% nicotine)'}, {'id': 'OG001', 'title': 'Product Variant B', 'description': 'MyBlu e-cigarette variant B (3.6% nicotine)'}, {'id': 'OG002', 'title': 'Product Variant C', 'description': 'MyBlu e-cigarette variant C (2.5% nicotine)'}, {'id': 'OG003', 'title': 'Product Variant D', 'description': 'MyBlu e-cigarette variant D (4.0% nicotine)'}, {'id': 'OG004', 'title': 'Product Variant E', 'description': 'MyBlu e-cigarette variant E (3.6% nicotine)'}, {'id': 'OG005', 'title': 'Product Variant F', 'description': 'MyBlu e-cigarette variant F (2.4% nicotine)'}, {'id': 'OG006', 'title': 'Product Variant G', 'description': 'MyBlu e-cigarette variant G (4.0% nicotine)'}, {'id': 'OG007', 'title': 'Product Variant H', 'description': 'MyBlu e-cigarette variant H (3.6% nicotine)'}], 'classes': [{'categories': [{'measurements': [{'value': '70.4', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '67.8', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '67.2', 'spread': '21.7', 'groupId': 'OG002'}, {'value': '63.7', 'spread': '22.1', 'groupId': 'OG003'}, {'value': '62.0', 'spread': '31.6', 'groupId': 'OG004'}, {'value': '56.2', 'spread': '34.4', 'groupId': 'OG005'}, {'value': '62.9', 'spread': '32.1', 'groupId': 'OG006'}, {'value': '63.0', 'spread': '29.4', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 days', 'description': 'Urge to smoke score: Subjects answer the following question "How strong is your urge to smoke right now?" using a visual analogue scale (VAS). The scale ranges from "Not at all", given a score of 0, to "Extremely", given a score of 100, after ad libitum use of the product.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABDC', 'description': 'Subjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).'}, {'id': 'FG001', 'title': 'BCAD', 'description': 'Same as previous but in a different randomization order'}, {'id': 'FG002', 'title': 'CDBA', 'description': 'Same as previous but in a different randomization order'}, {'id': 'FG003', 'title': 'DACB', 'description': 'Same as previous but in a different randomization order'}, {'id': 'FG004', 'title': 'EFHG', 'description': 'Subjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).'}, {'id': 'FG005', 'title': 'FGEH', 'description': 'Same as previous but in a different randomization order'}, {'id': 'FG006', 'title': 'GHFE', 'description': 'Same as previous but in a different randomization order'}, {'id': 'FG007', 'title': 'HEGF', 'description': 'Same as previous but in a different randomization order'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '40', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'ABDC', 'description': 'Subjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).'}, {'id': 'BG001', 'title': 'BCAD', 'description': 'Same as previous but in a different randomization order'}, {'id': 'BG002', 'title': 'CDBA', 'description': 'Same as previous but in a different randomization order'}, {'id': 'BG003', 'title': 'DACB', 'description': 'Same as previous but in a different randomization order'}, {'id': 'BG004', 'title': 'EFHG', 'description': 'Subjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).'}, {'id': 'BG005', 'title': 'FGEH', 'description': 'Same as previous but in a different randomization order'}, {'id': 'BG006', 'title': 'GHFE', 'description': 'Same as previous but in a different randomization order'}, {'id': 'BG007', 'title': 'HEGF', 'description': 'Same as previous but in a different randomization order'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'spread': '15.28', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '14.03', 'groupId': 'BG001'}, {'value': '47.6', 'spread': '8.73', 'groupId': 'BG002'}, {'value': '37.8', 'spread': '10.76', 'groupId': 'BG003'}, {'value': '44.6', 'spread': '10.88', 'groupId': 'BG004'}, {'value': '41.6', 'spread': '11.19', 'groupId': 'BG005'}, {'value': '43.0', 'spread': '11.51', 'groupId': 'BG006'}, {'value': '47.2', 'spread': '12.58', 'groupId': 'BG007'}, {'value': '43.3', 'spread': '11.45', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '29.4', 'spread': '5.5', 'groupId': 'BG002'}, {'value': '29.2', 'spread': '4.3', 'groupId': 'BG003'}, {'value': '26.4', 'spread': '7.3', 'groupId': 'BG004'}, {'value': '25.3', 'spread': '3.3', 'groupId': 'BG005'}, {'value': '28.2', 'spread': '3.7', 'groupId': 'BG006'}, {'value': '27.5', 'spread': '3.3', 'groupId': 'BG007'}, {'value': '27.6', 'spread': '4.4', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-18', 'size': 3553486, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-14T09:08', 'hasProtocol': True}, {'date': '2020-02-20', 'size': 1762043, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-14T09:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2020-06-10', 'resultsFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-11', 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Nicotine Concentration in Blood', 'timeFrame': '180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)', 'description': 'Maximum nicotine concentration in blood (Cmax)'}, {'measure': 'Concentration of Carboxyhemoglobin in Blood', 'timeFrame': 'Baseline and 8 days', 'description': 'Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.'}, {'measure': 'Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours', 'timeFrame': 'Baseline and 8 days', 'description': 'Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), excreted in urine during 24 hours (creatinine adjusted).'}, {'measure': 'Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours', 'timeFrame': 'Baseline and 8 days', 'description': 'Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA), a biomarker of exposure to acrolein, excreted in urine during 24 hours (creatinine adjusted).'}, {'measure': 'Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours', 'timeFrame': 'Baseline and 8 days', 'description': 'Change from baseline in the amount of S-phenyl mercapturic acid (S-PMA), a biomarker of exposure to benzene, excreted in urine during 24 hours (creatinine adjusted).'}], 'secondaryOutcomes': [{'measure': 'Level of White Blood Cells', 'timeFrame': 'Baseline and 8 days', 'description': 'The change from baseline in the level of white blood cells, a biomarker of potential harm.'}, {'measure': 'Spirometry: Forced Expiratory Volume in 1 Second', 'timeFrame': 'Baseline and 8 days', 'description': 'Forced expiratory volume in 1 second (FEV1) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.'}, {'measure': 'Spirometry: Forced Vital Capacity', 'timeFrame': 'Baseline and 8 days', 'description': 'Forced vital capacity (FVC) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.'}, {'measure': 'Subjective Measure: Urge to Smoke', 'timeFrame': '8 days', 'description': 'Urge to smoke score: Subjects answer the following question "How strong is your urge to smoke right now?" using a visual analogue scale (VAS). The scale ranges from "Not at all", given a score of 0, to "Extremely", given a score of 100, after ad libitum use of the product.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '34435305', 'type': 'DERIVED', 'citation': "Morris P, McDermott S, Chapman F, Verron T, Cahours X, Stevenson M, Thompson J, Chaudhary N, O'Connell G. Reductions in biomarkers of exposure to selected harmful and potentially harmful constituents following exclusive and partial switching from combustible cigarettes to myblu electronic nicotine delivery systems (ENDS). Intern Emerg Med. 2022 Mar;17(2):397-410. doi: 10.1007/s11739-021-02813-w. Epub 2021 Aug 26."}]}, 'descriptionModule': {'briefSummary': "This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study in adult smokers.\n\nSubjects are invited to participate to a second part of the study, for 5 additional days, to compare the use of MybluTM to the use of subject's usual brand combustible cigarettes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening\n* tested positive for urine cotinine (≥ 200 ng/mL) at Screening\n* exhaled carbon monoxide \\> 10 ppm (parts per million) at Screening\n\nExclusion Criteria:\n\n* relevant illness history\n* relevant medication use\n* body mass index (BMI) \\> 40 kg/m2 or \\< 18 kg/m2 at Screening\n* allergy to propylene glycol or glycerin\n* use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in\n* use of any prescription smoking cessation treatments within 3 months prior to Check-in\n* smokers who draw smoke from the cigarette into the mouth and throat but do not inhale\n* planning to quit smoking during the study\n* female subjects who are pregnant, lactating, or intend to become pregnant'}, 'identificationModule': {'nctId': 'NCT04430634', 'briefTitle': 'A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fontem Ventures BV'}, 'officialTitle': 'An Open-Label, Randomized, Crossover Study to Assess Nicotine Uptake, Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Puff Topography With Use of mybluTM Electronic Cigarettes in Adult Smokers', 'orgStudyIdInfo': {'id': 'CA22749'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABDC', 'description': 'Subjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).', 'interventionNames': ['Other: Myblu variant A', 'Other: Myblu variant B', 'Other: Myblu variant C', 'Other: Myblu variant D']}, {'type': 'EXPERIMENTAL', 'label': 'BCAD', 'description': 'Same as previous arm, but in a different randomization order.', 'interventionNames': ['Other: Myblu variant A', 'Other: Myblu variant B', 'Other: Myblu variant C', 'Other: Myblu variant D']}, {'type': 'EXPERIMENTAL', 'label': 'CDBA', 'description': 'Same as previous arm, but in a different randomization order.', 'interventionNames': ['Other: Myblu variant A', 'Other: Myblu variant B', 'Other: Myblu variant C', 'Other: Myblu variant D']}, {'type': 'EXPERIMENTAL', 'label': 'DACB', 'description': 'Same as previous arm, but in a different randomization order.', 'interventionNames': ['Other: Myblu variant A', 'Other: Myblu variant B', 'Other: Myblu variant C', 'Other: Myblu variant D']}, {'type': 'EXPERIMENTAL', 'label': 'EFHG', 'description': 'Subjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).', 'interventionNames': ['Other: Myblu variant E', 'Other: Myblu variant F', 'Other: Myblu variant G', 'Other: Myblu variant H']}, {'type': 'EXPERIMENTAL', 'label': 'FGEH', 'description': 'Same as previous arm, but in a different randomization order.', 'interventionNames': ['Other: Myblu variant E', 'Other: Myblu variant F', 'Other: Myblu variant G', 'Other: Myblu variant H']}, {'type': 'EXPERIMENTAL', 'label': 'GHFE', 'description': 'Same as previous arm, but in a different randomization order.', 'interventionNames': ['Other: Myblu variant E', 'Other: Myblu variant F', 'Other: Myblu variant G', 'Other: Myblu variant H']}, {'type': 'EXPERIMENTAL', 'label': 'HEGF', 'description': 'Same as previous arm, but in a different randomization order.', 'interventionNames': ['Other: Myblu variant E', 'Other: Myblu variant F', 'Other: Myblu variant G', 'Other: Myblu variant H']}], 'interventions': [{'name': 'Myblu variant A', 'type': 'OTHER', 'description': 'Use of Myblu e-cigarette with flavor A 2.4% nicotine', 'armGroupLabels': ['ABDC', 'BCAD', 'CDBA', 'DACB']}, {'name': 'Myblu variant B', 'type': 'OTHER', 'description': 'Use of Myblu e-cigarette with flavor B 3.6% nicotine', 'armGroupLabels': ['ABDC', 'BCAD', 'CDBA', 'DACB']}, {'name': 'Myblu variant C', 'type': 'OTHER', 'description': 'Use of Myblu e-cigarette with flavor C 2.5% nicotine', 'armGroupLabels': ['ABDC', 'BCAD', 'CDBA', 'DACB']}, {'name': 'Myblu variant D', 'type': 'OTHER', 'description': 'Use of Myblu e-cigarette with flavor D 4.0% nicotine', 'armGroupLabels': ['ABDC', 'BCAD', 'CDBA', 'DACB']}, {'name': 'Myblu variant E', 'type': 'OTHER', 'description': 'Use of Myblu e-cigarette with flavor E 3.6% nicotine', 'armGroupLabels': ['EFHG', 'FGEH', 'GHFE', 'HEGF']}, {'name': 'Myblu variant F', 'type': 'OTHER', 'description': 'Use of Myblu e-cigarette with flavor F 2.4% nicotine', 'armGroupLabels': ['EFHG', 'FGEH', 'GHFE', 'HEGF']}, {'name': 'Myblu variant G', 'type': 'OTHER', 'description': 'Use of Myblu e-cigarette with flavor G 4.0% nicotine', 'armGroupLabels': ['EFHG', 'FGEH', 'GHFE', 'HEGF']}, {'name': 'Myblu variant H', 'type': 'OTHER', 'description': 'Use of Myblu e-cigarette with flavor H 3.6% nicotine', 'armGroupLabels': ['EFHG', 'FGEH', 'GHFE', 'HEGF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fontem US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fontem Ventures BV', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}