A study to assess and compare health effect indicators in users of Vype vaping products, smokers, former smokers and never-smokers
- Conditions
- Biomarkers of toxicant exposure, biomarkers of potential harm and physiological measures in subjects who smoke, use Vype vaping products, have quit smoking or have never smokedNot Applicable
- Registration Number
- ISRCTN58921739
- Lead Sponsor
- British American Tobacco (United Kingdom)
- Brief Summary
2022 Protocol article in https://www.sciencepublishinggroup.com/journal/paperinfo?journalid=344&doi=10.11648/j.jher.20220802.17 (added 14/07/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37249753/ (added 20/06/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 222
All Subjects:
1. Subjects will be:
1.1.Males or females
1.2. 19 to 55 years of age, inclusive, demonstrated by appropriate proof of identification
2. Subjects will have a:
2.1. Body mass index (BMI) of 18.5 to 30.0 kg/m², inclusive
2.2. Body weight exceeding 52 kg (males) or 45 kg (females)
3. Subjects will be in good health, as judged by the PI or the appropriately qualified designee based on:
3.1.Medical history (confirmed by volunteer)
3.2.Physical examination
3.3. Vital signs assessment
3.4. 12-lead ECG
3.5.Clinical laboratory evaluations
3.6. Lung function tests/spirometry at screening
4. Subjects will have given their written informed consent to participate in the study and will have agreed to abide by the study restrictions
5. Subjects must demonstrate the ability to comprehend the informed consent form (ICF), be able to communicate well with the PI or the appropriately qualified designee, understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the PI or the appropriately qualified designee
6. Subjects will refrain from consuming alcohol within 24 hours prior to Screening
7. Subjects will refrain from consuming cruciferous vegetables, and grilled, fried or barbequed food, and avoid being in the presence of the cooking of cruciferous vegetables, and grilled, fried or barbequed food for 48 hours prior to Screening
Additional criteria for Arm A subjects only:
8. Subjects will be regular (daily) users of the Vype ePen 3 and/or Vype ePod vaping devices
9. Subjects will have used the Vype ePen 3 and/or Vype ePod vaping devices for a minimum of 6 months prior to Screening
10. Subjects will have a urine cotinine level > 200 ng/mL and an exhaled breath CO level < 7 ppm at Screening
Additional criteria for Arm B subjects only:
11. Subjects will be regular smokers of commercially manufactured filter cigarettes
12. Subjects will have smoked for at least one year prior to Screening
13. Subjects will typically smoke at least 10 CPD and must have a urine cotinine level >200ng/ml and an exhaled breath CO level =7 ppm at Screening
Additional criteria for Arm C subjects only:
14. Subjects will be former smokers of commercially manufactured filter cigarettes who quit smoking at least 6 months prior to Screening
15. Subjects will have a urine cotinine level < 200 ng/ml and an exhaled breath CO level <7 ppm at Screening
Additional criteria for Arm D subjects only:
16. Subjects will have never smoked (<100 cigarettes in their life and none within the six months prior to Screening)
17. Subjects will have a urine cotinine level < 200 ng/ml and an exhaled breath CO level <7 ppm at Screening
All Subjects:
1. Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening
2. Subjects who have donated:
2.1. =400 ml of blood within 90 days prior to screening
2.2. Plasma in the 7 days prior to screening
2.3. Platelets in the 6 weeks prior to screening
3. Subjects who have had an acute illness (e.g. upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to screening
4. Subjects who have a significant history of alcoholism or drug/chemical abuse (apart from known smoking/vaping history) within 24 months prior to Screening, as determined by the PI or the appropriately qualified designee
5. Subjects who have a positive urine drugs of abuse or breath alcohol screen (confirmed by repeat) at Screening
6. Subjects who:
6.1. Have serum hepatitis/are carriers of the hepatitis B surface antigen (HBsAg)
6.2. Are carriers of the hepatitis C antibody
6.3. Have a positive result for the test for human immunodeficiency virus (HIV) antibodies
6.4. have a positive result in the COVID test at screening indicating current, active infection
7. Subjects who have used prescription or over-the-counter (OTC) bronchodilator medication (e.g. inhaled or oral ß-adrenergic agonists) to treat a chronic condition within the 12 months prior to screening
8. Subjects who have received any medications or substances (other than nicotine) which:
8.1. Interfere with the cyclooxygenase pathway (e.g. anti-inflammatory drugs including aspirin and ibuprofen) within 14 days prior to Screening
8.2. Are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 half-lives of the drug (whichever is longer) prior to Screening
9. Subjects who would need to take prescription medication during the period beginning with screening and ending with discharge
10. Subjects who are unwilling or unable to comply with the study requirements
11. Employees and immediate relatives of the tobacco industry or the clinical site
12. Subjects who have any clinically relevant abnormal findings on the physical examination, medical history, ECG, lung function tests or clinical laboratory panel, unless deemed not clinically significant by the PI or the appropriately qualified designee
13. Subjects who have been diagnosed with a significant history of urticaria or asthma (childhood asthma is acceptable)
14. Subjects who have, or who have a history of, any clinically significant neurological, gastrointestinal, renal (including urinary tract infection or nephrolithiasis), hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the PI or the appropriately qualified designee, would jeopardise the safety of the subject or impact on the validity of the study results
15. Subjects who have previously been diagnosed with any form of malignancy
16. Subjects who are currently participating in another clinical trial (including follow-up)
17. Subjects who, in the opinion of the PI or the appropriately qualif
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method