Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-13 @ 3:02 PM
Study NCT ID:
NCT02032212
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tanvir.walele@uk.imptob.com', 'phone': '0044 177 933 7589', 'title': 'Tanvir Walele', 'organization': 'Imperial Tobacco Group'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 days', 'eventGroups': [{'id': 'EG000', 'title': 'EVP Unflavoured', 'description': 'Unflavoured e-vapour product', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EVP Flavoured', 'description': 'Flavoured e-vapour product', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nicotine Inhalator', 'description': 'Nicotine inhalator 15mg', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Conventional Cigarette', 'description': 'Conventional cigarette (commercially available)', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nicotine Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EVP Unflavoured', 'description': 'Unflavoured e-vapour product'}, {'id': 'OG001', 'title': 'EVP Flavoured', 'description': 'Flavoured e-vapour product'}, {'id': 'OG002', 'title': 'Nicotine Inhalator', 'description': 'Nicotine inhalator 15mg'}, {'id': 'OG003', 'title': 'Conventional Cigarette', 'description': 'Conventional cigarette (commercially available)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '33.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '41.6', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '45.2', 'groupId': 'OG002'}, {'value': '21.2', 'spread': '43.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours', 'description': 'Maximum plasma nicotine concentration (Cmax)', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EVP Unflavoured', 'description': 'Unflavoured e-vapour product'}, {'id': 'OG001', 'title': 'EVP Flavoured', 'description': 'Flavoured e-vapour product'}, {'id': 'OG002', 'title': 'Nicotine Inhalator', 'description': 'Nicotine inhalator 15mg'}, {'id': 'OG003', 'title': 'Conventional Cigarette', 'description': 'Conventional cigarette (commercially available)'}], 'classes': [{'categories': [{'measurements': [{'value': '425.3', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '277.2', 'spread': '33.7', 'groupId': 'OG001'}, {'value': '320.6', 'spread': '47.6', 'groupId': 'OG002'}, {'value': '2247.0', 'spread': '28.6', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours', 'unitOfMeasure': 'min*ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exhaled Carbon Monoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EVP Unflavoured', 'description': 'Unflavoured e-vapour product'}, {'id': 'OG001', 'title': 'EVP Flavoured', 'description': 'Flavoured e-vapour product'}, {'id': 'OG002', 'title': 'Nicotine Inhalator', 'description': 'Nicotine inhalator 15mg'}, {'id': 'OG003', 'title': 'Conventional Cigarette', 'description': 'Conventional cigarette (commercially available)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '0.78', 'groupId': 'OG002'}, {'value': '14.8', 'spread': '3.86', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '25 minutes', 'description': 'Measured with a Smokerlyser device', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nicotine Withdrawal Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EVP Unflavoured', 'description': 'Unflavoured e-vapour product'}, {'id': 'OG001', 'title': 'EVP Flavoured', 'description': 'Flavoured e-vapour product'}, {'id': 'OG002', 'title': 'Nicotine Inhalator', 'description': 'Nicotine inhalator 15mg'}, {'id': 'OG003', 'title': 'Conventional Cigarette', 'description': 'Conventional cigarette (commercially available)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.40', 'spread': '6.52', 'groupId': 'OG000'}, {'value': '6.80', 'spread': '7.32', 'groupId': 'OG001'}, {'value': '7.50', 'spread': '7.08', 'groupId': 'OG002'}, {'value': '8.10', 'spread': '8.93', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after the third product use', 'description': "Withdrawal symptoms were evaluated with the Minnesota Nicotine Withdrawal Scale questionnaire, to which only the 15 questions of the subject's part were completed. Subjects had to rate behaviours (e.g. angry, irritable, frustrated, depressed, restless, insomnia) from 0 (none) to 4 (severe). A higher score means more severe withdrawal symptoms. Scores range from a minimum of 0 to a maximum of 60.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nicotine Craving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EVP Unflavoured', 'description': 'Unflavoured e-vapour product'}, {'id': 'OG001', 'title': 'EVP Flavoured', 'description': 'Flavoured e-vapour product'}, {'id': 'OG002', 'title': 'Nicotine Inhalator', 'description': 'Nicotine inhalator 15mg'}, {'id': 'OG003', 'title': 'Conventional Cigarette', 'description': 'Conventional cigarette (commercially available)'}], 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '25.0', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '25.6', 'spread': '12.0', 'groupId': 'OG002'}, {'value': '22.8', 'spread': '14.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after the third product use', 'description': 'Craving was assessed with the Brief Questionnaire of Smoking Urges (QSU-Brief). Subject had to rate 10 statements, such as "I have a desire for a cigarette right now", by a number ranging from 1 (strongly disagree) to 7 (strongly agree). Scores can range from a minimum of 0 to a maximum of 70. A higher score means a stronger urge to smoke a cigarette.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1', 'description': 'Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.'}, {'id': 'FG001', 'title': 'Sequence 2', 'description': 'Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.'}, {'id': 'FG002', 'title': 'Sequence 3', 'description': 'Subjects in this arm used the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.'}, {'id': 'FG003', 'title': 'Sequence 4', 'description': 'Subjects in this arm used the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence 1', 'description': 'Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.'}, {'id': 'BG001', 'title': 'Sequence 2', 'description': 'Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the Nicotine inhalator on Day 4.'}, {'id': 'BG002', 'title': 'Sequence 3', 'description': 'Subjects in this arm used the Nicotine inhalator on Day 1 and the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.'}, {'id': 'BG003', 'title': 'Sequence 4', 'description': 'Subjects in this arm used the conventional cigarette on Day 1, the Nicotine inhalator on Day 2, the flavoured EVP on Day 3, the unflavoured EVP on Day 4.'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2014-01-06', 'resultsFirstSubmitDate': '2016-02-12', 'studyFirstSubmitQcDate': '2014-01-07', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-25', 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nicotine Plasma Concentration', 'timeFrame': '1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours', 'description': 'Maximum plasma nicotine concentration (Cmax)'}, {'measure': 'Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)', 'timeFrame': '1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours'}], 'secondaryOutcomes': [{'measure': 'Exhaled Carbon Monoxide', 'timeFrame': '25 minutes', 'description': 'Measured with a Smokerlyser device'}, {'measure': 'Nicotine Withdrawal Symptoms', 'timeFrame': '30 minutes after the third product use', 'description': "Withdrawal symptoms were evaluated with the Minnesota Nicotine Withdrawal Scale questionnaire, to which only the 15 questions of the subject's part were completed. Subjects had to rate behaviours (e.g. angry, irritable, frustrated, depressed, restless, insomnia) from 0 (none) to 4 (severe). A higher score means more severe withdrawal symptoms. Scores range from a minimum of 0 to a maximum of 60."}, {'measure': 'Nicotine Craving', 'timeFrame': '30 minutes after the third product use', 'description': 'Craving was assessed with the Brief Questionnaire of Smoking Urges (QSU-Brief). Subject had to rate 10 statements, such as "I have a desire for a cigarette right now", by a number ranging from 1 (strongly disagree) to 7 (strongly agree). Scores can range from a minimum of 0 to a maximum of 70. A higher score means a stronger urge to smoke a cigarette.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': "Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are otherwise known as electronic cigarettes. These may look like conventional cigarettes but do not contain tobacco.\n\nThe 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.\n\nThis trial is to evaluate the pharmacokinetic profile of an EVP.", 'detailedDescription': 'The principal part of this study evaluates the nicotine pharmacokinetic profile of conventional cigarettes, a nicotine inhalator, an unflavoured EVP and a flavoured EVP.\n\nA second part investigates the nicotine delivery of an EVP with four different nicotine doses.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI of 18-35kg/m2\n* Subjects must be established smokers\n* Subjects must have smoked five to 30 cigarettes per day for at least one year\n\nExclusion Criteria:\n\n* Subjects who have used nicotine replacement therapy within 14 days of the screening\n* Subjects who have donated blood within 12 months preceding study\n* Subjects with relevant illness history\n* Subjects positive for hepatitis or HIV\n* Subjects with history of drug or alcohol abuse\n* Subjects with lung function test or vital signs considered unsuitable\n* Subjects who are trying to stop smoking'}, 'identificationModule': {'nctId': 'NCT02032212', 'briefTitle': 'A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'Imperial Brands PLC'}, 'officialTitle': 'A Randomised, Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product, a Nicotine Inhalator and a Conventional Cigarette', 'orgStudyIdInfo': {'id': 'ITG EVP G1 S1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Subjects use the unflavoured EVP on Day 1, the flavoured EVP on Day 2, the nicotine inhalator on Day 3 and the conventional cigarette on Day 4.', 'interventionNames': ['Other: EVP unflavoured', 'Other: EVP flavoured', 'Other: Nicotine inhalator', 'Other: Conventional cigarette']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Subjects use the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.', 'interventionNames': ['Other: EVP unflavoured', 'Other: EVP flavoured', 'Other: Nicotine inhalator', 'Other: Conventional cigarette']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'Subjects use the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.', 'interventionNames': ['Other: EVP unflavoured', 'Other: EVP flavoured', 'Other: Nicotine inhalator', 'Other: Conventional cigarette']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'Subjects use the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.', 'interventionNames': ['Other: EVP unflavoured', 'Other: EVP flavoured', 'Other: Nicotine inhalator', 'Other: Conventional cigarette']}], 'interventions': [{'name': 'EVP unflavoured', 'type': 'OTHER', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}, {'name': 'EVP flavoured', 'type': 'OTHER', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}, {'name': 'Nicotine inhalator', 'type': 'OTHER', 'description': '15 mg nicotine Nicorette', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}, {'name': 'Conventional cigarette', 'type': 'OTHER', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF48 4DR', 'city': 'Merthyr Tydfil', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Simbec Research', 'geoPoint': {'lat': 51.74794, 'lon': -3.37779}}], 'overallOfficials': [{'name': 'Girish Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simbec Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial Brands PLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}