ISRCTN81075760已完成未知
A randomised, controlled study to evaluate the effects of switching from cigarette smoking to using a Tobacco Heating Product on health effect indicators in healthy subjects
British American Tobacco (Investments) Ltd0 个研究点目标入组 506 人开始时间: 2018年1月31日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 506
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31049783 protocol (added 07/05/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/32776101/ three-month results (added 15/04/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34196886/ six-month results (added 15/07/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36036342/ (added 01/09/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 05/03/2019:
- •1. Males or non-pregnant, non-lactating females, between 23 and 55 years of age, inclusive. Age verification will be performed by checking government issued identification (e.g. passport or driving licence) during Screening
- •2. Body mass index (BMI) between 17.6 and 32.0 kg/m2, inclusive, body weight exceeding 50 kg (males) or 40 kg (females)
- •3. Subjects will be in good health, as judged by the Investigator or their appropriately qualified designee based on: medical history, physical examination, vital signs assessment (blood pressure <140 mmHg systolic),12-lead ECG, clinical laboratory evaluations, lung function tests (Gold stage 1 is acceptable; see exclusion criterion 16).
- •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 Investigator or their appropriately qualified designee, understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator or their appropriately qualified designee
- •6. Subjects will be willing to refrain from consuming alcohol within 24 hours prior to Screening and Check-in at each study visit, with the exception of the Follow-up Visit
- •7. Subjects will be willing to refrain from consuming barbequed or chargrilled food, and avoid being in the presence of barbequed or chargrilled food for 48 hours prior to Check-in at each study visit. Subjects will also be willing to avoid food containing poppy seeds for 3 days before both Screening and Check-in at each study visit
- •Arms A, B and D:
- •8. Subjects will be regular smokers of commercially manufactured filter cigarettes and/or roll your own cigarettes.
- •9. Subjects will have smoked for at least five consecutive years prior to Screening
- •10. Subjects will typically smoke at least 10 and a maximum of 30 CPD and must have a urine cotinine level > 200 ng/mL and an exhaled breath CO level = 7 ppm at Screening
- •11. Subjects in Arm A who continue to smoke will be willing to use factory-manufactured non-mentholated cigarettes and/or roll your own cigarettes.
- •12. Subjects in Arms B will be willing to use the study product (THP) provided to them during the study
- •13. Subjects in Arm D will be willing to abstain from smoking and using NGPs
- •14. Subjects will have never smoked (<100 cigarettes in their life and none within 30 days prior to Screening) and will continue to not smoke or use any form of tobacco or nicotine-containing product (including THPs) for the duration of the study.
- •Previous inclusion criteria:
- •1. Males or non-pregnant, non-lactating females, between 23 and 55 years of age, inclusive
- •2. Body mass index (BMI) between 17.6 and 32.0 kg/m2, inclusive, body weight exceeding 50 kg (males) or 40 kg (females)
- •3. Subjects will be in good health, as judged by the Investigator or their appropriately qualified designee based on: medical history, physical examination, vital signs assessment (blood pressure <140 mmHg systolic
排除标准
- •Current exclusion criteria as of 05/03/2019:
- •1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a barrier method of contraception (i.e. a condom with spermicide) or to refrain from donating sperm from Visit 1 until the end of the Follow-up Visit
- •2. Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (i.e. a condom with spermicide) from the time of signing the ICF until the end of the Follow-up Visit
- •3. Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening and Visit 1. Any female subject who becomes pregnant during this study will be withdrawn
- •4. Subjects who have donated: =400 mL of blood within 12 weeks (male) or 16 weeks (female) prior to Visit 1, plasma in the 2 weeks prior to Visit 1, platelets in the 6 weeks prior to Visit 1
- •5. Subjects who have an acute illness (e.g. upper respiratory tract infection) requiring treatment within 4 weeks prior to Visit 1 (subjects who had viral infections that resolved =2 weeks prior to Visit 1 will be admissible to this study)
- •6. Subjects who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to Screening, as determined by the Investigator
- •7. Subjects who have a positive urine drugs of abuse screen (confirmed by repeat) at Screening or Visit 1 or a positive alcohol breath test (confirmed by repeat) at Screening or Visit 1
- •8. Subjects who are carriers of the hepatitis B surface antigen (HBsAg), hepatitis C antibody or have a positive result for the test for human immunodeficiency virus (HIV) antibodies
- •9. 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 Visit 1
- •10. Subjects who have received any medications or substances (other than tobacco) which interfere with the cyclooxygenase pathway (e.g. anti-inflammatory drugs including aspirin and ibuprofen) within 14 days prior to Visit 1, 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 Visit 1
- •11. Subjects who perform strenuous physical activity (exceeding the subject’s normal activity levels) within 7 days prior to Screening or Visit 1
- •12. Subjects who are unable to communicate effectively with the Investigator/study staff (i.e. language problem, poor mental development, or impaired cerebral function)
- •13. Subjects who are unwilling or unable to comply with the study restrictions and requirements
- •14. Employees and immediate relatives of the tobacco industry and the clinical site
- •15. Subjects who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first product use
- •16. Subjects who have any clinically relevant abnormal findings on the physical examination, medical history, ECG, lung function tests (post-bronchodilator FEV1/FVC < 0.7 and FEV1
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