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 sites506 target enrollmentJanuary 31, 2018

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: British American Tobacco (Investments) Ltd
Enrollment: 506
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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)

Registry

who.int

Start Date

January 31, 2018

End Date

March 31, 2020

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

British American Tobacco (Investments) Ltd

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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