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Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes 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 and tolerability of an EVP over two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVP | Experimental | Subject who use the EVP for up to 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVP | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Sitting systolic blood pressure (mmHg) | 24 months |
| Electrocardiogram (ECG): PR Interval | In electrocardiography, the PR interval is the period that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex. Variations in the PR interval can be associated with certain medical conditions. | 24 months |
| Lung Function Tests | Forced Vital Capacity (FVC) | 24 months |
| Clinical Laboratory Parameters | High density lipoprotein (HDL) cholesterol, change from baseline (BL) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Withdrawal Symptoms | Nicotine withdrawal symptoms were measured using the revised Minnesota Nicotine Withdrawal Scale (MWS-R) questionnaire. Extended total scores were used, i.e. the sum of the scores of all 15 questions of the questionnaire. Symptoms (e.g. angry, irritable, frustrated, depressed, restless, insomnia) were rated from 0 (none) to 4 (severe). Extended total scores may range from 0 to a maximum of 60. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Bush, MD | Covance Clinical Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Leeds | England | LS2 9LH | United Kingdom | ||
| Simbec Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | EVP Users | Subject who switch to use the electronic vapour product (EVP) for up to 2 years EVP |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EVP Users | Subjects who switch to use the EVP for up to 2 years EVP |
| 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 | Blood Pressure | Sitting systolic blood pressure (mmHg) | Posted | Mean | Standard Deviation | mmHg | 24 months |
|
|
24 months
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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 | EVP Users | Subjects who use the EVP EVP | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute pancreatitis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tanvir Walele | FontemVentures | 01779337589 | tanvir.walele@fontemventures.com |
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| 24 Months |
| Biomarkers of Exposure to Nicotine | The exposure to nicotine was measured by quantifying the change from BL in the amount of nicotine equivalents excreted in urine in 24-hours (AE24h). | 24 months |
| Biomarkers of Effect | Change from BL in the level of white blood cells. | 24 months |
| Merthyr Tydfil |
| Wales |
| CF48 4DR |
| United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Exhaled carbon monoxide (CO) | Mean | Standard Deviation | ppm |
|
| Carboxyhemoglobin | Mean | Standard Deviation | Percent of total hemoglobin |
|
| HDL cholesterol | High density lipoprotein (HDL) cholesterol, in mmol/L | Mean | Inter-Quartile Range | mmol/L |
|
| Biomarkers of exposure to nicotine | The baseline amount of nicotine equivalents excreted in urine in 24-hours (AE24h). | Mean | Standard Deviation | mg |
|
| Level of white blood cells | Mean | Inter-Quartile Range | G/L |
|
|
| Primary | Electrocardiogram (ECG): PR Interval | In electrocardiography, the PR interval is the period that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex. Variations in the PR interval can be associated with certain medical conditions. | Posted | Mean | Standard Deviation | ms | 24 months |
|
|
|
| Primary | Lung Function Tests | Forced Vital Capacity (FVC) | Posted | Mean | Standard Deviation | Liters | 24 months |
|
|
|
| Primary | Clinical Laboratory Parameters | High density lipoprotein (HDL) cholesterol, change from baseline (BL) | Posted | Mean | 95% Confidence Interval | mmol/L | 24 months |
|
|
|
| Secondary | Nicotine Withdrawal Symptoms | Nicotine withdrawal symptoms were measured using the revised Minnesota Nicotine Withdrawal Scale (MWS-R) questionnaire. Extended total scores were used, i.e. the sum of the scores of all 15 questions of the questionnaire. Symptoms (e.g. angry, irritable, frustrated, depressed, restless, insomnia) were rated from 0 (none) to 4 (severe). Extended total scores may range from 0 to a maximum of 60. | Posted | Mean | Standard Deviation | score on a scale | 24 Months |
|
|
|
| Secondary | Biomarkers of Exposure to Nicotine | The exposure to nicotine was measured by quantifying the change from BL in the amount of nicotine equivalents excreted in urine in 24-hours (AE24h). | Posted | Mean | 95% Confidence Interval | mg | 24 months |
|
|
|
| Secondary | Biomarkers of Effect | Change from BL in the level of white blood cells. | Posted | Mean | 95% Confidence Interval | G/L | 24 months |
|
|
|
| 209 |
| 7 |
| 209 |
| 60 |
| 209 |
| Concussion | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Right occipital stroke | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
|
| Spontaneous abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment | Right knee injury |
|
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Nicotine dependence | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (16.1) | Systematic Assessment |
|
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