ISRCTN72157335已完成不适用
A single-blinded, controlled study to evaluate the effects of a novel cigarette on biomarkers of exposure, filter analysis and sensory tests, when used by healthy smokers
British American Tobacco (Investments) Ltd (UK)0 个研究点目标入组 300 人开始时间: 2009年3月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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