A Randomized, Controlled, Open-label, 4 Parallel Arms Study to Demonstrate Reductions in Exposure to Selected Harmful and Potentially Harmful Constituents (HPHC) of Cigarette (CIG) Smoke in Healthy Smokers Switching to Different Versions of Tobacco Heating System (THS) Compared to Continuing CIG Smoking, for 5 Days in Confinement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
研究概览
简要总结
This was a randomized, controlled, open-label, 4 parallel arm study with a stratified randomization by sex (a quota for each sex [females and males] of at least 40% overall).
This study aimed to demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected Harmful and Potentially Harmful Constituents (HPHC) in smokers switching from cigarettes (CIG) to each of the Tobacco Heating System (THS) variants with different heating technology (Blade device, Induction Mono device, or Induction Mid device, respectively), compared with smokers who continued to smoke CIG.
详细描述
Study Title: Reduced Exposure to Harmful and Potentially Harmful Constituents (HPHC) in Smokers Switching From Cigarettes to Different Versions of the Tobacco Heating System (THS)
Who carried out the research? This research was sponsored and funded by Philip Morris Products S.A.
What public involvement there was in the study? Ninety-one healthy, currently smoking, adults participated in this study.
Where and when the study took place? The study was conducted at a clinical trial facility managed by a contract research organization in Belfast, Northern Ireland, from November 4th 2022 to February 4th 2023.
Who participated in the study? Ninety-one healthy male or female adults, aged between 21 and 65 years, participated in this study. All participants were currently smoking. The participants did not plan to quit using tobacco and/or nicotine products within the next 3 months and had smoked continuously for at least the last 3 years prior to joining the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has signed the ICF and is able to understand the information provided in the ICF.
- •Subject has been a smoker for ≥3 years prior to the screening visit (smoking cessation attempts during this period, if any, did not last > 6 months in total).
- •Subject has continuously smoked on average ≥10 commercially available regular CIGs/day over the last 4 weeks. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL).
- •Subject is healthy as judged by the Investigator based on available assessments from the screening period (e.g., safety laboratory, spirometry, vital signs, physical examination, ECG, and medical history).
- •Subject does not plan to quit smoking within the next three months.
排除标准
- •As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological, social reason).
- •Subject is legally incompetent, or physically or mentally incapable of giving consent (e.g., in emergency situations, under guardianship, prisoners).
- •Subject has a clinically relevant disease which requires medication (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease) or any other medical condition (including safety laboratory), which as per the judgment of the Investigator would jeopardize the safety of the subject.
- •Subject experienced within 30 days prior to screening/admission a body temperature >37.5°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.) or the subject has a confirmed or suspected active COVID-19 infection (based on the signs and symptoms observed at the time of assessment)
- •As per the Investigator's judgment, the subject has medical conditions which do or will require a medical intervention (e.g., start of treatment, surgery, hospitalization) during the study participation, which may interfere with the study participation and/or study results.
- •Subject has relevant history of, or current asthma condition or COPD condition, and/or clinically significant findings.
- •Subject has donated blood or received whole blood or blood products within 3 months.
- •BMI < 18.5 kg/m2 or ≥ 32.0 kg/m
- •Positive serology test for HIV 1/2, HBV, or HCV.
- •Subject has a positive alcohol breath test and/or has a history of alcohol disorder that could interfere with their participation in the study.
- •The subject has a positive urine drug test.
- •Subject or one of their family members is a current or former employee of the tobacco or e-cigarette industry.
- •Subject or one of their family members is an employee of the investigational site or of any other parties involved in the study.
- •Subject has participated in another clinical study within 3 months.
- •Subject has been previously screened or enrolled in this study.
- •Subject is pregnant (does not have negative pregnancy tests at screening and at admission) or is breastfeeding.
- •For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.
研究组 & 干预措施
THS Blade device
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
干预措施: THS Blade device (Other)
THS Induction Mono device
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
干预措施: THS Induction Mono device (Other)
THS Induction Mid device
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
干预措施: THS Induction Mid device (Other)
Cigarette
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.
(Every subject brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
干预措施: CIG (Other)
结局指标
主要结局
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
时间窗: 5 days
Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
Concentration of 2-cyanoethyl Mercapturic Acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA)
时间窗: 5 days
Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
时间窗: 5 days
Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
Concentration of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
时间窗: 5 days
Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
Levels of Carboxyhemoglobin (COHb)
时间窗: 5 days
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Blood measurements performed in the evening of Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
次要结局
未报告次要终点