Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887117
• Other study ID #: P1-EXC-01-EU
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: November 2021
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 16, 2020
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 V1.
• 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 V2.
• Subject does not plan to quit smoking within 6 months after V1.

Exclusion Criteria:

• 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/m2.
• 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).

Related Conditions & MeSH terms

• Exercise Capacity
• Smoking

Intervention

Other:
• IQOS + Exercise Training Program
Switch to IQOS use + participation in a training program
• IQOS without Exercise Training Program
Switch to IQOS use only, without participation in a training program
• Cigarette Smoking + Exercise Training Program
Continue to smoke cigarettes + participation in a training program
• Smoking Abstinence + Exercise Training Program
Switch to smoking abstinence + participation in a training program

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Mannheim GmbH	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Oxygen Uptake (VO2max, Absolute Values)	To measure VO2max during maximal cycle ergometer exercise (expressed in absolute values [mL*min-1]).	Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	Maximal Oxygen Uptake (VO2max, Weight-adjusted Values)	To measure VO2max during maximal cycle ergometer exercise (expressed in weight-adjusted [mL*kg-1*min-1] values).	Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	Maximal Oxygen Uptake (VO2max, Fat-free Weight Adjusted Values)	To measure VO2max during maximal cycle ergometer exercise (expressed in fat-free weight adjusted values [mL*kg-1*min-1]).	Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	Exercise Capacity	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).	Measured at baseline (V3), at week 1 (V4), and at week 12 (V43)
Primary	Exercise Training Intensity: Cumulative Work	To measure cumulative work (calories) produced during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.	Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
Primary	Exercise Training Intensity: Average Work Rate	To measure the average work rate (watt) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.	Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
Primary	Exercise Training Intensity: Average Heart Rate	To measure the average heart rate (bpm) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.	Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
Primary	Exercise Training Intensity: Time Spent at Maximal Heart Rate	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.	Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks.
Primary	Hemoglobin Mass	To measure Hemoglobin mass (g), measured with the carbon monoxide-rebreathing method.	Measured at Baseline (V3) and week 12 (V43).
Primary	Red Blood Cell Volume	To measure Red blood cell volume (mL), measured with the carbon monoxide-rebreathing method.	Measured at Baseline (V3) and week 12 (V43).
Primary	Plasma Volume	To measure Plasma volume (mL), measured with the carbon monoxide-rebreathing method.	Measured at Baseline (V3) and week 12 (V43).
Primary	Total Blood Volume	To measure total blood volume (mL), measured with the carbon monoxide-rebreathing method.	Measured at Baseline (V3) and week 12 (V43).
Primary	Capillary Blood Lactate Levels	To measure changes from baseline of Capillary blood lactate levels (mmol/L), measured (with a portable lactate analyzer) during VO2max test.	Measured at Baseline and week 15.
Primary	Ventilation at VO2 Max	To measure ventilation (L/min) at VO2max.	Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	Respiratory Rate	To measure respiratory rate (breaths per minute) at VO2max.	Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	VCO2	To measure VCO2 (L/min) at VO2 max.	Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	Respiratory Exchange Ratio	To measure the respiratory exchange ratio (VCO2/VO2) at VO2max	Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	Rating of Perceived Capacity by Sex	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.	Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	Rating of Perceived Exertion	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.	Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	Heart Rate	To measure changes from baseline of heart rate (bpm) during VO2max test.	Measured at Baseline, at week 1, and at week 15.
Primary	Oxygen Uptake	To measure changes from baseline of Oxygen uptake during VO2max test. (mL/min)	Measured at Baseline, at week 1, and at week 15.
Primary	High Density Lipoprotein (HDL)	To measure HDL concentrations in serum (mg/dL).	Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	Low Density Lipoprotein (LDL)	To measure LDL concentrations in serum (mg/dL).	Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	Very Low Density Lipoprotein (VLDL)	To measure VLDL concentrations in serum (mg/dL).	Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	High Sensitivity C-reactive Protein (Hs-CRP)	To measure hs-CRP concentrations in serum (mg/dL).	Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	Growth Hormone	To measure growth hormone concentrations in serum (ng/mL).	Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	Hemoglobin A1c (HbA1c)	To measure glycosylated hemoglobin (HbA1c in whole blood).	Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	Resting Systolic Blood Pressure	To measure resting systolic blood pressure in mmHg.	Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	Resting Pulse Rate	To measure resting heart rate in bpm.	Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	Body Fat	To measure body fat as a percentage.	Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	Waist Circumference	To measure waist circumference in cm.	Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
Primary	Body Weight	To measure body weight in kilograms.	Measured at each visit, starting from Baseline (V3) until week 12 (V43).
Primary	Exhaled Carbon Monoxide	To measure exhaled carbon monoxide (ppm).	Measured at each visit, starting from Baseline (V3) until week 12 (V43).
Primary	Carboxyhemoglobin	To measure Carboxyhemoglobin (COHb), assayed from whole blood. Expressed as % of saturation of hemoglobin.	Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	NEQ	To measure Nicotine equivalents (NEQ) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.	Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	Total NNAL	To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.	Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	CEMA	To measure 2-cyanoethylmercapturic acid (CEMA) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.	Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
Primary	Nicotine/Tobacco Product Use (Cigarettes)	To measure self-reported number of any nicotine/tobacco product used on a daily basis.	Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
Primary	Nicotine/Tobacco Product Use (HeatSticks)	To measure self-reported number of any nicotine/tobacco product used on a daily basis.	Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
Primary	Nicotine/Tobacco Product Use (E-cigarettes)	To measure self-reported number of any nicotine/tobacco product used on a daily basis.	Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.