N/A
N=93
Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity
Smoking · Exercise Capacity
Bottom Line
View on ClinicalTrials.gov: NCT03887117 ↗Enrolled (actual)
93
Serious AEs
2.2%
Results posted
Dec 2021
Primary outcome: Primary: Maximal Oxygen Uptake (VO2max, Absolute Values) — 1878; 2027; 2197; 1950 mL/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IQOS + Exercise Training Program (Other); IQOS without Exercise Training Program (Other); Cigarette Smoking + Exercise Training Program (Other); Smoking Abstinence + Exercise Training Program (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Oxygen Uptake (VO2max, Absolute Values) |
1878; 2027; 2197; 1950; 2750; 1620 | — |
| PRIMARY Maximal Oxygen Uptake (VO2max, Weight-adjusted Values) |
27.3; 27.4; 28.9; 25.1; 34.7; 24.4 | — |
| PRIMARY Maximal Oxygen Uptake (VO2max, Fat-free Weight Adjusted Values) |
37.5; 38.4; 38.3; 34.8; 44.1; 34.3 | — |
| PRIMARY Exercise Capacity |
2283; 2366; 2330; 2156; 2110; 2871 | — |
| PRIMARY Exercise Training Intensity: Cumulative Work |
169; 222; 208; 203; 203; 196 | — |
| PRIMARY Exercise Training Intensity: Average Work Rate |
70.7; 87.6; 84.4; 82.8; 81.7; 78.7 | — |
| PRIMARY Exercise Training Intensity: Average Heart Rate |
125; 127; 123; 110; 119; 127 | — |
| PRIMARY Exercise Training Intensity: Time Spent at Maximal Heart Rate |
33.7; 26.1; 14.2; 361; 29.7; 42.2 | — |
| PRIMARY Hemoglobin Mass |
861; 796; 905; 883; 766; 1194 | — |
| PRIMARY Red Blood Cell Volume |
2541; 2353; 2681; 2605; 2269; 3523 | — |
| PRIMARY Plasma Volume |
3429; 3156; 3558; 3521; 3252; 4840 | — |
| PRIMARY Total Blood Volume |
5970; 5508; 6239; 6126; 5521; 8363 | — |
| PRIMARY Capillary Blood Lactate Levels |
— | — |
| PRIMARY Ventilation at VO2 Max |
74.8; 78.9; 87.3; 71.9; 109; 55.7 | — |
| PRIMARY Respiratory Rate |
34.5; 37.5; 37.1; 35.2; 36.0; 29.0 | — |
| PRIMARY VCO2 |
2.21; 2.36; 2.58; 2.24; 3.23; 1.70 | — |
| PRIMARY Respiratory Exchange Ratio |
1.18; 1.16; 1.19; 1.16; 1.17; 1.05 | — |
| PRIMARY Rating of Perceived Capacity by Sex |
7.77; 8.22; 8.17; 8.00; 5.00; 8.50 | — |
| PRIMARY Rating of Perceived Exertion |
— | — |
| PRIMARY Heart Rate |
— | — |
| PRIMARY Oxygen Uptake |
— | — |
| PRIMARY High Density Lipoprotein (HDL) |
49.3; 48.2; 47.1; 52.1; 55.4; 48.6 | — |
| PRIMARY Low Density Lipoprotein (LDL) |
124; 111; 122; 115; 155; 127 | — |
| PRIMARY Very Low Density Lipoprotein (VLDL) |
14.7; 13.7; 15.8; 13.7; 12.5; 15.6 | — |
| PRIMARY High Sensitivity C-reactive Protein (Hs-CRP) |
2.10; 2.19; 0.804; 1.80; 1.17; 1.40 | — |
| PRIMARY Growth Hormone |
2.15; 1.37; 2.49; 4.03; 2.02; 1.25 | — |
| PRIMARY Hemoglobin A1c (HbA1c) |
5.44; 5.39; 5.38; 5.53; 5.36; 5.41 | — |
| PRIMARY Resting Systolic Blood Pressure |
118; 121; 118; 122; 108; 117 | — |
| PRIMARY Resting Pulse Rate |
68.8; 68.2; 67.9; 65.8; 73.8; 65.1 | — |
| PRIMARY Body Fat |
27.8; 28.2; 25.6; 27.3; 20.5; 28.1 | — |
| PRIMARY Waist Circumference |
82.6; 83.7; 84.4; 84.9; 78.4; 82.1 | — |
| PRIMARY Body Weight |
72; 75.7; 75.5; 77.5; 69.3; 72.2 | — |
| PRIMARY Exhaled Carbon Monoxide |
20.8; 20.8; 19.7; 18.6; 20.4; 25.4 | — |
| PRIMARY Carboxyhemoglobin |
1.92; 2.37; 1.71; 1.74; 2.50; 3.29 | — |
| PRIMARY NEQ |
14.9; 14.2; 10.5; 12.9; 14.0; 13.2 | — |
| PRIMARY Total NNAL |
170; 239; 164; 166; 244; 147 | — |
| PRIMARY CEMA |
140; 170; 135; 128; 144; 147 | — |
| PRIMARY Nicotine/Tobacco Product Use (Cigarettes) |
16.8; 19.0; 17.4; 17.7; 24.1; 17.5 | — |
| PRIMARY Nicotine/Tobacco Product Use (HeatSticks) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Nicotine/Tobacco Product Use (E-cigarettes) |
0; 0; 0.0952; 0; 0; 0 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03887117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.