SmokingNCT03887117

Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity

A study testing IQOS + Exercise Training Program, IQOS without Exercise Training Program and Cigarette Smoking + Exercise Training Program in people with Smoking and Exercise Capacity, run by Philip Morris Products S.A. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Smoking, Exercise Capacity
What is being tested?: IQOS + Exercise Training Program, IQOS without Exercise Training Program and Cigarette Smoking + Exercise Training Program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 1 siteGermany
Study dates: 1 Feb 2019to 16 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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).

Trial locations and contacts

1 site in 1 country.

Germany1 site

CRS Clinical Research Services Mannheim GmbH
Mannheim, D-68167

Other trials in Germany

About this study

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

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.

Read the detailed 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.

Conditions: Smoking, Exercise Capacity
Being tested: IQOS + Exercise Training Program, IQOS without Exercise Training Program, Cigarette Smoking + Exercise Training Program, Smoking Abstinence + Exercise Training Program
Keywords: IQOS, Heated Tobacco
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03887117
Study group	Role	What they receive
IQOS-1	Active comparator	IQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program. Receives: Other: IQOS + Exercise Training Program
IQOS-2	Active comparator	IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program. Receives: Other: IQOS without Exercise Training Program
Cigarette Smoking	Active comparator	Cigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program. Receives: Other: Cigarette Smoking + Exercise Training Program
Smoking Abstinence	Active comparator	Smoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program. Receives: Other: Smoking Abstinence + Exercise Training Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201916 Mar 2020

First posted22 Mar 2019
Study start1 Feb 2019
Primary completion25 Nov 2019
Study completion16 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SmokingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03887117
Sponsor's protocol ID: P1-EXC-01-EU
Status last verified: Nov 2021
First submitted: 28 Feb 2019
Last updated: 27 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03887117
Acronym / sponsor ID: P1-EXC-01-EU
Conditions: Smoking, Exercise Capacity
Keywords: IQOS, Heated Tobacco
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: 1 Feb 2019 (actual)
Primary completion: 25 Nov 2019 (actual)
Study completion: 16 Mar 2020 (actual)
First posted: 22 Mar 2019 (actual)
Results: Posted 27 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
IQOS-1	Active comparator	Other: IQOS + Exercise Training ProgramIQOS + Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.
IQOS-2	Active comparator	Other: IQOS without Exercise Training ProgramIQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.
Cigarette Smoking	Active comparator	Other: Cigarette Smoking + Exercise Training ProgramCigarette Smoking + Exercise Training Program Subjects randomized to continued cigarette smoking and participation in an exercise training program.
Smoking Abstinence	Active comparator	Other: Smoking Abstinence + Exercise Training ProgramSmoking Abstinence + Exercise Training Program Subjects randomized to smoking abstinence and participation in an exercise training program.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IQOS + Exercise Training ProgramSwitch to IQOS use + participation in a training program	Other	IQOS-1
IQOS without Exercise Training ProgramSwitch to IQOS use only, without participation in a training program	Other	IQOS-2
Cigarette Smoking + Exercise Training ProgramContinue to smoke cigarettes + participation in a training program	Other	Cigarette Smoking
Smoking Abstinence + Exercise Training ProgramSwitch to smoking abstinence + participation in a training program	Other	Smoking Abstinence

Primary outcome

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]).
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).
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]).
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).
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.
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.
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.
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.
Hemoglobin Mass
Time frame: Measured at Baseline (V3) and week 12 (V43).
To measure Hemoglobin mass (g), measured with the carbon monoxide-rebreathing method.
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.
Plasma Volume
Time frame: Measured at Baseline (V3) and week 12 (V43).
To measure Plasma volume (mL), measured with the carbon monoxide-rebreathing method.
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.
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.
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.
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.
VCO2
Time frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure VCO2 (L/min) at VO2 max.
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
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.
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.
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.
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)
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).
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).
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).
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).
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).
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).
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.
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.
Body Fat
Time frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure body fat as a percentage.
Waist Circumference
Time frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
To measure waist circumference in cm.
Body Weight
Time frame: Measured at each visit, starting from Baseline (V3) until week 12 (V43).
To measure body weight in kilograms.
Exhaled Carbon Monoxide
Time frame: Measured at each visit, starting from Baseline (V3) until week 12 (V43).
To measure exhaled carbon monoxide (ppm).
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.
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.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 27 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IQOS-1	25	25
IQOS-2	15	14
Cigarette Smoking	26	25
Smoking Abstinence	27	25

Primary outcome: Maximal Oxygen Uptake (VO2max, Absolute Values)

Time frame: Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).. Mean (95% Confidence Interval). Unit: mL/min

Measure	Cigarette Smoking n = 21	IQOS-1 n = 19	IQOS-2 n = 13	Smoking Abstinence n = 22	Dual-1 n = 1	Dual-2 n = 1	Other n = 8
Acute Baseline (V3)	1878 (1715 to 2040)	2027 (1799 to 2255)	2197 (1788 to 2605)	1950 (1708 to 2191)	2750	1620	2103 (1775 to 2430)
Acute Effect (V4)	1823 (1686 to 1960)	2062 (1823 to 2300)	2156 (1747 to 2565)	2071 (1791 to 2351)	2770	1770	2094 (1721 to 2466)
Training Effect (V43)	1977 (1807 to 2147)	2178 (1889 to 2468)	2150 (1709 to 2591)	2292 (1984 to 2601)	–	–	2182 (1628 to 2736)

Population analysed: AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Primary outcome: Maximal Oxygen Uptake (VO2max, Weight-adjusted Values)

Time frame: Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).. Mean (95% Confidence Interval). Unit: mL/(kg*min)

Measure	Cigarette Smoking n = 21	IQOS-1 n = 19	IQOS-2 n = 13	Smoking Abstinence n = 22	Dual-1 n = 1	Dual-2 n = 1	Other n = 8
Acute Baseline (V3)	27.3 (24.8 to 29.8)	27.4 (24.9 to 29.9)	28.9 (24.6 to 33.3)	25.1 (22.9 to 27.3)	34.7	24.4	25.8 (21.8 to 29.8)
Acute Effect (V4)	26.6 (24.4 to 28.8)	27.9 (25.1 to 30.7)	28.2 (24.4 to 32.0)	26.7 (24.0 to 29.4)	34.5	27.0	25.4 (21.3 to 29.5)
Training Effect (V43)	27.9 (25.1 to 30.8)	28.8 (25.7 to 31.8)	27.7 (23.1 to 32.3)	29.6 (26.4 to 32.7)	–	–	30.9 (27.9 to 34.0)

Population analysed: AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Primary outcome: Maximal Oxygen Uptake (VO2max, Fat-free Weight Adjusted Values)

Time frame: Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).. Mean (95% Confidence Interval). Unit: mL/(kg*min)

Measure	Cigarette Smoking n = 21	IQOS-1 n = 19	IQOS-2 n = 13	Smoking Abstinence n = 22	Dual-1 n = 1	Dual-2 n = 1	Other n = 8
Acute Baseline (V3)	37.5 (34.4 to 40.5)	38.4 (35.3 to 41.6)	38.3 (34.0 to 42.6)	34.8 (32.7 to 36.9)	44.1	34.3	34.4 (29.5 to 39.3)
Acute Effect (V4)	37.0 (33.8 to 40.2)	39.8 (35.6 to 44.0)	37.6 (34.3 to 41.0)	37.0 (34.6 to 39.5)	45.3	40.2	34.1 (30.1 to 38.1)
Training Effect (V43)	40.3 (36.4 to 44.2)	39.8 (36.5 to 43.1)	38.1 (34.4 to 41.8)	42.0 (38.7 to 45.2)	–	–	44.7 (36.2 to 53.1)

Population analysed: AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Primary outcome: Exercise Capacity

Time frame: Measured at baseline (V3), at week 1 (V4), and at week 12 (V43). Mean (95% Confidence Interval). Unit: seconds

Measure	Cigarette Smoking n = 21	IQOS-1 n = 19	IQOS-2 n = 13	Smoking Abstinence n = 22	Dual-1 n = 1	Dual-2 n = 1	Other n = 8
Acute Baseline (V3)	2283 (2033 to 2534)	2366 (2109 to 2623)	2330 (2013 to 2648)	2156 (1975 to 2337)	2110	2871	2147 (1722 to 2571)
Acute Effect (V4)	2205 (2017 to 2394)	2189 (1949 to 2429)	2170 (1877 to 2462)	2210 (1921 to 2498)	2402	3006	2190 (1820 to 2561)
Training Effect (V43)	1985 (1728 to 2242)	2123 (1926 to 2319)	2374 (1970 to 2777)	1849 (1623 to 2075)	–	–	1982 (1465 to 2498)

Population analysed: AEECS: As Exposed Exercise Compliant Set. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).

Adverse events

Time frame: Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 24 weeks for each subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cigarette Smoking	0 of 22 (0%)	12 of 22 (54.5%)	0 of 22
IQOS-1	0 of 22 (0%)	10 of 22 (45.5%)	0 of 22
IQOS-2	1 of 13 (7.7%)	8 of 13 (61.5%)	0 of 13
Smoking Abstinence	1 of 24 (4.2%)	12 of 24 (50%)	0 of 24
Other	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Armin Schultz, MD principal investigator

CRS Clinical Research Services Mannheim GmbH

Christelle Haziza, PhD study chair

Philip Morris Products S.A.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Oxygen Uptake (VO2max, Absolute Values) (time frame: Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03887117.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.