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Completed

NCT Number: NCT03887117

Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity

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.

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Key information

Conditions

Smoking Behavior Exercise Capacity

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRS Clinical Research Services Mannheim GmbH

Mannheim, D-68167, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

IQOS + Exercise Training Program

Other

Switch to IQOS use + participation in a training program

IQOS without Exercise Training Program

Other

Switch to IQOS use only, without participation in a training program

Cigarette Smoking + Exercise Training Program

Other

Continue to smoke cigarettes + participation in a training program

Smoking Abstinence + Exercise Training Program

Other

Switch to smoking abstinence + participation in a training program

Primary outcomes

  1. Maximal Oxygen Uptake (VO2max, Absolute Values)

    Time frame: 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]).

  2. Maximal Oxygen Uptake (VO2max, Weight-adjusted Values)

    Time frame: 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).

  3. Maximal Oxygen Uptake (VO2max, Fat-free Weight Adjusted Values)

    Time frame: 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]).

  4. Exercise Capacity

    Time frame: 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).

  5. Exercise Training Intensity: Cumulative Work

    Time frame: 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.

  6. Exercise Training Intensity: Average Work Rate

    Time frame: 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.

  7. Exercise Training Intensity: Average Heart Rate

    Time frame: 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.

  8. Exercise Training Intensity: Time Spent at Maximal Heart Rate

    Time frame: 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.

  9. Hemoglobin Mass

    Time frame: Measured at Baseline (V3) and week 12 (V43).

    To measure Hemoglobin mass (g), measured with the carbon monoxide-rebreathing method.

  10. Red Blood Cell Volume

    Time frame: Measured at Baseline (V3) and week 12 (V43).

    To measure Red blood cell volume (mL), measured with the carbon monoxide-rebreathing method.

  11. Plasma Volume

    Time frame: Measured at Baseline (V3) and week 12 (V43).

    To measure Plasma volume (mL), measured with the carbon monoxide-rebreathing method.

  12. Total Blood Volume

    Time frame: Measured at Baseline (V3) and week 12 (V43).

    To measure total blood volume (mL), measured with the carbon monoxide-rebreathing method.

  13. Capillary Blood Lactate Levels

    Time frame: 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.

  14. Ventilation at VO2 Max

    Time frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

    To measure ventilation (L/min) at VO2max.

  15. Respiratory Rate

    Time frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

    To measure respiratory rate (breaths per minute) at VO2max.

  16. VCO2

    Time frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

    To measure VCO2 (L/min) at VO2 max.

  17. Respiratory Exchange Ratio

    Time frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

    To measure the respiratory exchange ratio (VCO2/VO2) at VO2max

  18. Rating of Perceived Capacity by Sex

    Time frame: 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.

  19. Rating of Perceived Exertion

    Time frame: 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.

  20. Heart Rate

    Time frame: Measured at Baseline, at week 1, and at week 15.

    To measure changes from baseline of heart rate (bpm) during VO2max test.

  21. Oxygen Uptake

    Time frame: Measured at Baseline, at week 1, and at week 15.

    To measure changes from baseline of Oxygen uptake during VO2max test. (mL/min)

  22. High Density Lipoprotein (HDL)

    Time frame: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

    To measure HDL concentrations in serum (mg/dL).

  23. Low Density Lipoprotein (LDL)

    Time frame: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

    To measure LDL concentrations in serum (mg/dL).

  24. Very Low Density Lipoprotein (VLDL)

    Time frame: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

    To measure VLDL concentrations in serum (mg/dL).

  25. High Sensitivity C-reactive Protein (Hs-CRP)

    Time frame: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

    To measure hs-CRP concentrations in serum (mg/dL).

  26. Growth Hormone

    Time frame: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

    To measure growth hormone concentrations in serum (ng/mL).

  27. Hemoglobin A1c (HbA1c)

    Time frame: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

    To measure glycosylated hemoglobin (HbA1c in whole blood).

  28. Resting Systolic Blood Pressure

    Time frame: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

    To measure resting systolic blood pressure in mmHg.

  29. Resting Pulse Rate

    Time frame: Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).

    To measure resting heart rate in bpm.

  30. Body Fat

    Time frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

    To measure body fat as a percentage.

  31. Waist Circumference

    Time frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).

    To measure waist circumference in cm.

  32. Body Weight

    Time frame: Measured at each visit, starting from Baseline (V3) until week 12 (V43).

    To measure body weight in kilograms.

  33. Exhaled Carbon Monoxide

    Time frame: Measured at each visit, starting from Baseline (V3) until week 12 (V43).

    To measure exhaled carbon monoxide (ppm).

  34. Carboxyhemoglobin

    Time frame: 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.

  35. NEQ

    Time frame: 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.

  36. Total NNAL

    Time frame: 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.

  37. CEMA

    Time frame: 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.

  38. Nicotine/Tobacco Product Use (Cigarettes)

    Time frame: 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.

  39. Nicotine/Tobacco Product Use (HeatSticks)

    Time frame: 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.

  40. Nicotine/Tobacco Product Use (E-cigarettes)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Philip Morris Products S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 22, 2019
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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