jRCT1030220458已完成不适用
A cross-sectional study to demonstrate favorable differences in Biomarkers of Potential Harm following at least one year of Tobacco Heating System (THS) use compared to cigarette smoking.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 主要终点
- Carboxyhemoglobin (COHb) in blood
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 30age old over 至 60age old under（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Subject is able to understand the information provided in the main ICF and has signed the main ICF.
- •Subject is 30-60 years old.
- •Subject is healthy based on ECG, spirometry, vital signs, physical examination, medical history and Investigator's assessment.
- •Cigarette smokers:
- •Has smoked >= 10 cigarettes/day on average (no brand restriction) over the past 2 years prior to screening.
- •Has smoked >= 10 cigarettes/day on average (no brand restriction) for at least 10 years.
- •Has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past 2 years prior to screening.
- •Smoking status will be verified by urinary cotinine test (>= 200 ng/mL) and CO breath test (>= 10 ppm (1)).
- •Has used >= 10 HeatSticks/day on average over the past 2 years prior to screening.
- •Has smoked >= 10 cigarettes/day on average (no brand restriction) for at least 8 years prior to switching to THS.
- •10.Has smoked < 30 cigarettes/month and used other tobacco products or e-cigarettes < daily over the past 2 years prior to screening.
- •Product use will be verified by urinary cotinine test (>= 200 ng/mL) and CO breath test (< 10 ppm).
- •Former cigarette smokers:
- •Has not smoked cigarettes or used any tobacco or nicotine-containing products on a daily basis over the past 2 years prior to screening.
- •Has smoked >= 10 cigarettes/day on average (no brand restriction) for at least 8 years prior to stopping smoking.
- •Smoking status will be verified by urinary cotinine test (< 100 ng/mL) and CO breath test (< 10 ppm).
排除标准
- •Exclusion criteria:
- •As per the judgment of the Investigator, subject cannot participate in the study for any
- •reason (e.g., medical, psychiatric and/or social reason). The Investigator should
- •specifically evaluate the subject eligibility in light of COVID-19 risk factors and local
- •Subject has/had clinically relevant diseases (including but not limited to gastrointestinal,
- •renal, hepatic, neurological, hematological, endocrine, oncological, urological,
- •immunological, pulmonary, and cardiovascular disease) or conditions that in the opinion
- •of the investigator would jeopardize the safety of the subject or affect the validity of the
- •study results.
- •Subject has/had within 30 days prior to screening a body temperature > 37.5 or an
- •acute illness (e.g., upper-respiratory-tract infection, viral infection, etc.) or the subject
- •is confirmed or suspected of having active COVID-19 infection (based on the signs and
- •symptoms observed at the time of assessment) at screening.
- •Subject has used any prescribed or over-the-counter systemic medication with an impact
- •on WBC or 8-epi-PGF2alfa within 5 half-lives of the medication prior to enrollment in the
- •study (please refer to Appendix B).
- •Subject has high blood pressure (hypertension), defined as > 139 mmHg systolic and/or
- •> 89 mmHg diastolic or is currently treated with medication controlling high blood
- •Subject who has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at postbronchodilator
- •(BD) spirometry.
- •Subject who has (FEV1/FVC) < 0.75 (pre-BD) and reversibility in FEV1 (that is both >
- •12% and > 200 mL from pre- to post-BD values).
- •Subject who has a body mass index (BMI) < 18.5 or >= 30 kg/m
- •Subject with positive alcohol and/or drug screening test results.
- •Pregnant or breast-feeding female subject.
结局指标
主要结局
Carboxyhemoglobin (COHb) in blood
Biomarkers of Exposure (BoExp) to HPHCs
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine
Biomarkers of Exposure (BoExp) to HPHCs (expressed as concentration adjusted to creatinine)
White Blood Cell total count (WBC) in blood
Biomarkers of Potential Harm (BoPH) for core pathophysiological pathways underlying the main smoking-related diseases: Inflammation
8-epi-Prostaglandin-F2alfa (8-epi-PGF2alfa) in urine
Biomarkers of Potential Harm (BoPH) for core pathophysiological pathways underlying the main smoking-related diseases: Oxidative stress (expressed as concentration adjusted to creatinine)
次要结局
- Neutrophil to Lymphocyte Ratio (NLR)
- High-sensitivity C-Reactive Protein (hs-CRP)
- Homocysteine (HCY)
- Myeloperoxidase (MPO)
- Triglycerides (TG)
- Fibrinogen
- Glycated Hemoglobin (HbA1c)
- FEV1/FVC
- Nicotine Equivalents (NEQ) in urine
- Short Form Health Survey (SF-36) domain scores
- 2-Cyanoethyl Mercapturic Acid N-Acetyl-S-(2-cyanoethyl)-L-cysteine (2CyEMA) in urine
- ABOUT - Health and Functioning domain scores
- Adverse events (AEs)
- Serious adverse events (SAEs)
研究者
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