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Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes or electronic nicotine delivery devices/systems. These may look like conventional cigarettes but do not contain tobacco.
The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.
This trial is to evaluate the safety of an e-vapour product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e-vapour product (EVP) | Experimental | Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP). |
|
| Conventional cigarette (CC) | Active Comparator | Subjects who continue smoking their usual conventional cigarette (CC) brand. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-vapour product | Other | Smokers of conventional cigarettes who switch to use an e-vapour product. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Frequency of adverse events | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Carbon Monoxide | Level of exhaled carbon monoxide at Week 12 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Bush, MD | Covance Clinical Research Unit, Springfield House, Hyde Street, Leeds LS2 9LH, UK | Principal Investigator |
| Girish Sharma, MD | Simbec Research, Merthyr Tydfil, CF48 4DR, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Leeds | England | LS2 9HL | United Kingdom | ||
| Simbec Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | E-vapour Product (EVP) | Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP). |
| FG001 | Conventional Cigarette (CC) | Subjects who continue smoking their usual conventional cigarette (CC) brand. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | E-vapour Product (EVP) | Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP). |
| BG001 | Conventional Cigarette (CC) | Subjects who continue smoking their usual conventional cigarette (CC) brand. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | Frequency of adverse events | All subjects who used the study product at least once. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of adverse events | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E-vapour Product (EVP) | Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment | Puncture wound, left hand, first finger |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ana Cravo | Fontem Ventures | +441173322528 | AnaMaria.Cravo@fontemventures.com |
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| Conventional cigarette | Other | Smokers of conventional cigarettes who continue smoking conventional cigarettes. |
|
| Merthyr Tydfil |
| Wales |
| CF48 4DR |
| United Kingdom |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Exhaled Carbon Monoxide (eCO) | Mean | Standard Deviation | parts per million (ppm) |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Exhaled Carbon Monoxide | Level of exhaled carbon monoxide at Week 12 | Measure performed on subjects who completed the 12-week study (286 in the e-vapour product arm and 100 in the conventional cigarette arm). | Posted | Mean | Standard Deviation | parts per million (ppm) | 12 weeks |
|
|
|
| 5 |
| 306 |
| 271 |
| 306 |
| EG001 | Conventional Cigarette (CC) | Subjects who continue smoking their usual conventional cigarette (CC) brand. | 0 | 102 | 74 | 102 |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment | Right lobar pneumonia |
|
| Arrhythmia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment | Sudden death due to severe cardiac arrhythmia as confirmed by post mortem |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Desire to smoke | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
|
| Irritability | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
|
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