A 26-week Extension Study to Determine the Biological and Functional Changes in Healthy Smokers Who Switched From Conventional Cigarettes (CC) to Tobacco Heating System 2.2 (THS 2.2) Compared to Those Who Continued to Smoke CC in the ZRHR-ERS-09-US Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 672
- 试验地点
- 34
- 主要终点
- Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).
研究概览
简要总结
The objective of the ZRHR-ERS-09-EXT-US study is to further assess the effect of the Tobacco Heating System 2.2 (THS 2.2), a candidate Modified Risk Tobacco Product, compared to conventional cigarettes (CC) on the components of the "smokers' health profile" for a prolonged period of 26 weeks, providing additional information to the results of the original study ZRHR-ERS-09-US of 26-week exposure (NCT02396381). In total, the ZRHR-ERS-09-EXT-US study will extend the exposure period to 52 weeks.
详细描述
The ZRHR-ERS-09-EXT-US study is a 26-week extension of the original study ZRHR-ERS-09-US.
The subjects in the Full Analysis Set - As Exposed (FAS-EX) included subjects for combined analyses from the original six month study (ZRHR-ERS-09-US ) who did not enter the extension study (ZRHR-ERS-09-EXT-US).
This study was conducted as a separate investigation, as a follow-up of the randomized exposure period of the original study, extending the exposure from Week 26 (Visit 10 [V10]) to Week 52 (Visit 16 [V16]), and using the same sites.
Subjects continued to use the product they were randomized to in the original study ZRHR-ERS-09-US (THS 2.2 arm or CC arm).
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject completed V10 of the original study (ZRHR-ERS-09-US).
- •The subject is willing to comply to study procedures and to continue to use the product he/she was allocated to during the original study (THS 2.2 or CC) for an additional 26 weeks at V
- •Subject has given written informed consent to enter the 26-week extension study at V10.
排除标准
- •Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
- •As per judgment of the PI(s) or designee(s), the subject cannot participate in the study for any reason (e.g. medical, psychiatric and/or social reason).
- •Subject has made an attempt to quit using tobacco-containing products (e.g. CC and THS 2.2) during the original study.
- •Female subject is pregnant or breast feeding.
- •Female subject who does not agree to use an acceptable method of effective contraception.
结局指标
主要结局
Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).
时间窗: 52 weeks
Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).
时间窗: 52 weeks
Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).
时间窗: 52 weeks
FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.
Levels of White Blood Cells (WBC).
时间窗: 52 weeks
Total count in blood (GI/L). Mean values are provided as descriptive statistics.
Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).
时间窗: 52 weeks
Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).
时间窗: 52 weeks
Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Levels of High Density Lipoprotein C (HDL-C).
时间窗: 52 weeks
Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.
Levels of Carboxyhemoglobin (COHb).
时间窗: 52 weeks
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric Mean values are provided as descriptive statistics.
次要结局
未报告次要终点