A Randomized, Controlled, Open-label, 4-arm Parallel Group Study to Evaluate the Effect of Switching From Cigarette Smoking to the Use of IQOS in Healthy Adult Current Smokers on Exercise Capacity and Trainability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Total Blood Volume
研究概览
简要总结
This exploratory study is part of the global clinical assessment program of IQOS. It was designed to provide scientific evidence to further substantiate the reduced risk potential of using a heated tobacco product (the Tobacco Heating System [THS] marketed as IQOS) as compared to smoking cigarettes. The main goals of this exploratory study were to assess whether switching from cigarette smoking to using IQOS would influence 1) maximum oxygen uptake during incremental exercise (VO2max) and exercise capacity, 2) ability to perform exercise training and thereby influence 3) VO2max after 12 weeks of exercise training, 4) physiological parameters and biological health markers, and finally 5) physical activity levels in daily life.
详细描述
This exploratory study, with healthy adult smokers, was designed without product use restrictions (ad libitum product use) in order to replicate as closely as possible "real life" conditions. Subjects randomized to the cigarette and IQOS arms were asked to buy their own cigarettes or HeatSticks, respectively. Subjects randomized to the smoking abstinence (SA) arm were instructed to stay smoking abstinent until the end of the study. Subjects in the SA arm received smoking abstinence support and, in order to prevent relapse to cigarette smoking during the training program, were also allowed to use nicotine replacement therapy.
Mobile health technology was used in the study to explore the impact on switching from smoking to using IQOS on physical activity in daily real-world living conditions. The wearable enabled non-invasive recording of physical activity in an objective manner throughout the study. However, results collected from this device will be reported separately.
It should be noted that some study outcomes were reported graphically, rather than numerically. Consequently, these outcomes have not been included in this results disclosure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Smoking, healthy subject based on safety laboratory, ECG, spirometry, vital signs, physical examination, medical history and Investigator's assessment.
- •Subject has been smoking for at least three years prior to V
- •Subject has been smoking ≥ 10 cigarettes per day over the last 12 months. Smoking status will be verified by a urinary cotinine ≥ 200 ng/mL and CO exhaled breath test > 10 ppm both at V1 and V
- •Subject does not plan to quit smoking within 6 months after V1.
排除标准
- •Subject has a clinically relevant disease which requires medication (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary [such as but not limited to pulmonary oedema, asthma], and cardiovascular [such as, but not limited to myocardial infarction, unstable angina, uncontrolled arrhythmias, heart failure], disease) or any other clinically significant medical condition (including abnormal safety laboratory result as per CTCAE), which as per the judgment of the Investigator would jeopardize the safety of the subject.
- •Subject performs more than 45 min of vigorous physical activity per week.
- •Subject takes medication influencing blood volume such as erythropoietin, diuretics and beta blockers, or diabetic medications.
- •Subject cannot participate in the study for any reason other than medical as per the Investigator's judgment (e.g. psychological and/or social reason)
- •For women only: subject is pregnant (does not have negative pregnancy tests at V1 and at V2) or is breastfeeding.
- •For women of childbearing potential : female subject who does not agree to using an acceptable method of effective contraception during the entire study.
- •Subject has a BMI < 18.5 kg/m2 or BMI ≥ 30 kg/m
- •Subject has a positive urine drug screen.
- •Subject has been previously screened for this study.
- •Subject, or one of their family members (e.g., spouse, parent, sibling or child), is a current or former employee of the tobacco industry.
- •Subject, or one of their family members (e.g. spouse, parent, sibling or child), is an employee of the investigational site or any other parties involved in the study.
- •Subject is legally incompetent, or physically or mentally incapable of giving consent (e.g., emergency situation, under guardianship, prisoners, or subjects who are involuntarily incarcerated).
研究组 & 干预措施
IQOS-1
IQOS + Exercise Training Program
Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
干预措施: IQOS + Exercise Training Program (Other)
IQOS-2
IQOS without Exercise Training Program
Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
干预措施: IQOS without Exercise Training Program (Other)
Cigarette Smoking
Cigarette Smoking + Exercise Training Program
Subjects randomized to continued cigarette smoking and participation in an exercise training program.
干预措施: Cigarette Smoking + Exercise Training Program (Other)
Smoking Abstinence
Smoking Abstinence + Exercise Training Program
Subjects randomized to smoking abstinence and participation in an exercise training program.
干预措施: Smoking Abstinence + Exercise Training Program (Other)
结局指标
主要结局
Total Blood Volume
时间窗: Measured at Baseline (V3) and week 12 (V43).
To measure total blood volume (mL), measured with the carbon monoxide-rebreathing method.
Exercise Training Intensity: Average Work Rate
时间窗: Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
To measure the average work rate (watt) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
Plasma Volume
时间窗: Measured at Baseline (V3) and week 12 (V43).
To measure Plasma volume (mL), measured with the carbon monoxide-rebreathing method.
Capillary Blood Lactate Levels
时间窗: Measured at Baseline and week 15.
To measure changes from baseline of Capillary blood lactate levels (mmol/L), measured (with a portable lactate analyzer) during VO2max test.
Very Low Density Lipoprotein (VLDL)
时间窗: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure VLDL concentrations in serum (mg/dL).
Maximal Oxygen Uptake (VO2max, Absolute Values)
时间窗: Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure VO2max during maximal cycle ergometer exercise (expressed in absolute values \[mL\*min-1\]).
Rating of Perceived Capacity by Sex
时间窗: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure Rating of Perceived Capacity (RPC), determined by using the RPC scale. The RPC scale is a list of physical activities arranged in order, with a scale of values from least strenuous (1) to most exhausting (18 for women, 20 for men). Subjects choose the most strenuous activity, with corresponding value, which they could sustain for 30 minutes.
Rating of Perceived Exertion
时间窗: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure changes from baseline of the Rating of Perceived Exertion, determined by using the Borg scale. The Borg RPE scale is a numerical scale that ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion." Subjects choose a number from the scale that best describes their level of exertion during a physical activity.
Oxygen Uptake
时间窗: Measured at Baseline, at week 1, and at week 15.
To measure changes from baseline of Oxygen uptake during VO2max test. (mL/min)
High Density Lipoprotein (HDL)
时间窗: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure HDL concentrations in serum (mg/dL).
Low Density Lipoprotein (LDL)
时间窗: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure LDL concentrations in serum (mg/dL).
Hemoglobin Mass
时间窗: Measured at Baseline (V3) and week 12 (V43).
To measure Hemoglobin mass (g), measured with the carbon monoxide-rebreathing method.
Ventilation at VO2 Max
时间窗: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure ventilation (L/min) at VO2max.
Respiratory Rate
时间窗: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure respiratory rate (breaths per minute) at VO2max.
VCO2
时间窗: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure VCO2 (L/min) at VO2 max.
Maximal Oxygen Uptake (VO2max, Weight-adjusted Values)
时间窗: Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure VO2max during maximal cycle ergometer exercise (expressed in weight-adjusted \[mL\*kg-1\*min-1\] values).
Exercise Capacity
时间窗: Measured at baseline (V3), at week 1 (V4), and at week 12 (V43)
To measure exercise capacity, by measuring time to complete a pre-defined work (determined as 25% more work than the study subject produced during baseline VO2max test) on a cycle ergometer (seconds).
Exercise Training Intensity: Cumulative Work
时间窗: Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
To measure cumulative work (calories) produced during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
Exercise Training Intensity: Time Spent at Maximal Heart Rate
时间窗: Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
To measure the time (seconds) spent at 0-50%, 50-60%, 60-70%, 70-80 % and \>80% of maximal heart rate during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
Red Blood Cell Volume
时间窗: Measured at Baseline (V3) and week 12 (V43).
To measure Red blood cell volume (mL), measured with the carbon monoxide-rebreathing method.
High Sensitivity C-reactive Protein (Hs-CRP)
时间窗: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure hs-CRP concentrations in serum (mg/dL).
Resting Pulse Rate
时间窗: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure resting heart rate in bpm.
Body Fat
时间窗: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure body fat as a percentage.
Body Weight
时间窗: Measured at each visit, starting from Baseline (V3) until week 12 (V43).
To measure body weight in kilograms.
Maximal Oxygen Uptake (VO2max, Fat-free Weight Adjusted Values)
时间窗: Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure VO2max during maximal cycle ergometer exercise (expressed in fat-free weight adjusted values \[mL\*kg-1\*min-1\]).
Exercise Training Intensity: Average Heart Rate
时间窗: Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
To measure the average heart rate (bpm) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
Respiratory Exchange Ratio
时间窗: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure the respiratory exchange ratio (VCO2/VO2) at VO2max
Resting Systolic Blood Pressure
时间窗: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure resting systolic blood pressure in mmHg.
Nicotine/Tobacco Product Use (HeatSticks)
时间窗: Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
To measure self-reported number of any nicotine/tobacco product used on a daily basis.
Growth Hormone
时间窗: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure growth hormone concentrations in serum (ng/mL).
Heart Rate
时间窗: Measured at Baseline, at week 1, and at week 15.
To measure changes from baseline of heart rate (bpm) during VO2max test.
Hemoglobin A1c (HbA1c)
时间窗: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure glycosylated hemoglobin (HbA1c in whole blood).
Carboxyhemoglobin
时间窗: Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure Carboxyhemoglobin (COHb), assayed from whole blood. Expressed as % of saturation of hemoglobin.
Total NNAL
时间窗: Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.
CEMA
时间窗: Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure 2-cyanoethylmercapturic acid (CEMA) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.
NEQ
时间窗: Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
To measure Nicotine equivalents (NEQ) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.
Waist Circumference
时间窗: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure waist circumference in cm.
Exhaled Carbon Monoxide
时间窗: Measured at each visit, starting from Baseline (V3) until week 12 (V43).
To measure exhaled carbon monoxide (ppm).
Nicotine/Tobacco Product Use (Cigarettes)
时间窗: Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
To measure self-reported number of any nicotine/tobacco product used on a daily basis.
Nicotine/Tobacco Product Use (E-cigarettes)
时间窗: Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
To measure self-reported number of any nicotine/tobacco product used on a daily basis.
次要结局
未报告次要终点