Exposure to cigarette toxicants Injury, Occupational Diseases, Poisoning Toxic effect of other and unspecified substances
Conditions
Interventions
The 6 weeks clinical trial will be conducted as per the principles of good clinical practice. The safety of the subjects participating in the study will be evaluated prior to and post study.
The stu
Sponsors
British American Tobacco (Investments) Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study would enrol 250 healthy adult habitual smokers of 6-7 mg (N = 100) and 1-2 mg (N = 150) ISO tar yield cigarettes and 50 healthy adult non-smokers to take part in the study. Inclusion criteria for all participants: 1. Subjects of either sex, of any ethnic origin, 21 years of age or older 2. No clinically significant abnormal findings, as judged by the Principal Investigator, on the physical examination, electrocardiogram (ECG), clinical laboratory test results, lung function tests or medical history during screening 3. Voluntarily provide written Informed Consent and demonstrate ability to comprehend the Informed Consent Form 4. Refrain from consuming methylxanthine-containing products (e.g. caffeine) within 24 hours of the first day of each confinement visit 5. Refrain from consuming alcohol from 72 hours prior to the first day of each confinement visit. 6. Female subjects must have negative urine pregnancy test at screening. Other acceptable criteria for including women would be sexual abstinence (provided it is the preferred and usual lifestyle of the subject); women not of child bearing potential (tubal occlusion, hysterectomy, bilateral salpingectomy) Additional inclusion criteria for smoking groups: 7. Regular smokers whose chosen brand is both within one of the required ISO tar bands and have blend style/mechanics that are typical of the German market 8. Smokers smoking their chosen brand for a minimum of 6 months and have smoked for at least 3 years prior to screening 9. Typically smoke between 6 and 30 cigarettes per day 10. Subjects willing to switch to a novel cigarette Additional inclusion criteria for non-smoking groups: 11. Individuals who have not smoked for at least five years and have a urinary continine level of <10 ng/ml
Exclusion criteria
Exclusion criteria: 1. Clinically relevant gastrointestinal, renal, hepatic, neurologic, haematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other health condition 2. Clinically relevant abnormal findings on the physical examination, medical history, or clinical laboratory results unless deemed not clinically significant by the Principal Investigator 3. History of participation in clinical trial within 90 days prior to screening 4. History of 400 mL or more blood loss within 90 days prior to screening 5. Acute illness (e.g., upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to enrolment 6. History of drug or alcohol abuse 7. Positive alcohol breath test and urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methamphetine, morphine, methadone, tricyclic antidepressants [TCA] and marijuana [THC]). 8. Positive HIV or hepatitis screen (checked only at screening) 9. History of use of bronchodilator medication (e.g., inhaled or oral beta-agonists) within the 12 months prior to study enrolment 10. History of chronic medication which interferes with the cyclooxygenase pathway (anti-inflammatory drugs such as aspirin or ibuprofen) 11. Any prescribed chronic systemic medication within 14 days of enrolment (except for hormonal contraceptive and hormone replacement therapy) 12. History of intake of drugs or substances known to be inducers of cytochrome P450 enzymes within 28 days prior to screening 13. Women of child bearing potential who fail to use any reliable contraception. 14. Pregnant or lactating women 15. Smokers of cigarettes that are not within the required ISO tar bands or smoke cigarettes that have been identified as atypical of the German Market with respect to blend style and mechanics 16. Smokers who smoke less than 6 and more than 30 cigarettes per day 17. Smokers consuming any nicotine or tobacco products other than filter cigarettes 18. Smokers who are known to only take puffs of smoke without inhaling or observed with similar smoking pattern during the study 19. Non-smokers with levels of cotinine >10 ng/ml in their urine test 20. Employees of the tobacco industry, journalism, TV and radio reporting, public relations, market research and advertising
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate and compare cigarette smoke exposure in healthy adult smokers using both biomarkers of exposure and filter analysis and to quantify any changes in these exposure estimates following a switch from commercial to novel cigarettes. Data collection will be carried out as follows: 1. Urine collection for biomarkers of exposure, exhaled CO at 2, 4 and 6 weeks 2. Cigarette filter tips collection every 7 days and on each day of stay in the clinic to assess mouth level exposure of whole smoke | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine changes in the following measures during consumption of novel cigarettes and commercial cigarettes: 1.1. Sensory perception questionnaire prior to switching, immediately at the end of first day after switching, end of 6th week 1.2. Smoking behaviour including puffing and inhalation behaviour, assessed by Smoking Analyser (SA7) and life shirt jacket at 2 and 4 weeks 1.3. Quality of life using SF-36® Health Survey prior to switching and at the end of 6th week 1.4. Basic physiological measures: medical history, physical examination, pulmonary function test, vital signs, ECG at screening, end of 2nd, 4th and 6th week 2. To analyse genotype and gene expression to support the interpretation of the biomarkers of exposure: 2.1. Blood sample collection prior to switching for genotyping and gene expression, and at the end of 6th week for gene expression only | — |
Countries
Germany
Outcome results
None listed