Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity

NCT03887117 | Completed Results

• 1 other identifier: P1-EXC-01-EU
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking; Exercise Capacity

Keywords

IQOS; Heated Tobacco

Outcome Measures

Primary Outcomes (40)

• 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).

• 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).

• 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).

• 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)

• 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.

• 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.

• 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.

• 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.

• Hemoglobin Mass

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

  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 at Baseline (V3) and week 12 (V43).

• Plasma Volume

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

  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 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 at Baseline and week 15.

• Ventilation at VO2 Max

  To measure ventilation (L/min) at VO2max.

  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 at Baseline (V3), at week 1 (V4), and at week 12 (V43).

• VCO2

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

  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 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 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 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 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 at Baseline, at week 1, and at week 15.

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• Resting Pulse Rate

  To measure resting heart rate in bpm.

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

• Body Fat

  To measure body fat as a percentage.

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

• Waist Circumference

  To measure waist circumference in cm.

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

• Body Weight

  To measure body weight in kilograms.

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

• Exhaled Carbon Monoxide

  To measure exhaled carbon monoxide (ppm).

  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 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 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 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 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.

  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.

  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.

  Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.

Study Arms (4)

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.

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.

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.

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.

Other: Smoking Abstinence + Exercise Training Program

Interventions

IQOS + Exercise Training Program OTHER

Switch to IQOS use + participation in a training program

IQOS-1

IQOS without Exercise Training Program OTHER

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

IQOS-2

Cigarette Smoking + Exercise Training Program OTHER

Continue to smoke cigarettes + participation in a training program

Cigarette Smoking

Smoking Abstinence + Exercise Training Program OTHER

Switch to smoking abstinence + participation in a training program

Smoking Abstinence

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, D-68167, Germany

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christelle Haziza, Global Head Clinical Research and Execution
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 58 242 11 11

Study Officials

• Armin Schultz, MD

  CRS Clinical Research Services Mannheim GmbH

  PRINCIPAL INVESTIGATOR

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 22, 2019
• Study Start: February 1, 2019
• Primary Completion: November 25, 2019
• Study Completion: March 16, 2020
• Last Updated: December 27, 2021
• Results First Posted: December 27, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)