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History of Changes for Study: NCT03887117
Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity
Latest version (submitted November 4, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 20, 2019 None (earliest Version on record)
2 April 3, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 August 19, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 November 5, 2019 Study Status
5 December 13, 2019 Study Status
6 March 18, 2020 Recruitment Status, Study Status
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Results Submission Events
7 November 4, 2021 Study Status, Outcome Measures, Arms and Interventions, Study Description, Document Section, Results and Study Design
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Study NCT03887117
Submitted Date:  March 20, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: P1-EXC-01-EU
Brief Title: Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2019
Overall Status: Active, not recruiting
Study Start: February 1, 2019
Primary Completion: October 2019 [Anticipated]
Study Completion: September 2020 [Anticipated]
First Submitted: February 28, 2019
First Submitted that
Met QC Criteria:
March 20, 2019
First Posted: March 22, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
March 20, 2019
Last Update Posted: March 22, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Philip Morris Products S.A.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study is part of the global clinical assessment program of IQOS. It is designed to provide scientific evidence to further substantiate the reduced risk potential of using a heated tobacco product (IQOS) as compared to smoking cigarettes. The main goals of this exploratory study are to assess whether switching from cigarette smoking to using IQOS will 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.
Detailed Description:

This study, with healthy adult smokers, is designed as a study 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 will be asked to buy their own cigarettes or HeatSticks, respectively. Subjects randomized to the smoking abstinence (SA) arm will be instructed to stay smoking abstinent until the end of the study. Subjects in the SA arm will receive smoking abstinence support and, in order to prevent relapse to cigarette smoking during the training program, will also be allowed to use nicotine replacement therapy.

Mobile health technology will be 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 will enable non-invasive recording of physical activity in an objective manner throughout the study.

Open or close this module Conditions
Conditions: Smoking
Exercise Capacity
Keywords: IQOS
Heated Tobacco
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 90 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: IQOS-1

IQOS + Exercise Training Program

Subjects randomized to IQOS use will switch to IQOS use and participate in an exercise training program.

IQOS + Exercise Training Program
Switch to IQOS use + participation in a training program
Active Comparator: IQOS-2

No Training

Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program.

No Training
Switch to IQOS use only, without participation in a training program
Active Comparator: Cigarette Smoking

Cigarette Smoking + Exercise Training Program

Subjects randomized to continued cigarette smoking and participation in an exercise training program.

Cigarette Smoking + Exercise Training Program
Continue to smoke cigarettes + participation in a training program
Active Comparator: Smoking Abstinence

Smoking Abstinence + Exercise Training Program

Subjects randomized to smoking abstinence and participation in an exercise training program.

Smoking Abstinence + Exercise Training Program
Switch to smoking abstinence + participation in a training program
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Maximal Oxygen Uptake (VO2max, absolute values)
[ Time Frame: Measured at baseline, at week 1, and at week 15. ]

To measure changes from baseline of VO2max during maximal cycle ergometer exercise (expressed in absolute [mL*min-1]values).
2. Maximal Oxygen Uptake (VO2max, weight-adjusted values)
[ Time Frame: Measured at baseline, at week 1, and at week 15. ]

To measure changes from baseline of 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, at week 1, and at week 15. ]

To measure changes from baseline of 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, at week 1, and at week 15. ]

To measure changes from baseline of 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 (min:sec).
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 change in cumulative work (calories and calories/kg body weight) 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 change in the average work rate (watt and watt/kg body weight) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
7. Exercise Training Intensity: Average Work Rate (during each interval)
[ Time Frame: Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, over 12 weeks. ]

To measure change in the average work rate (watt and watt/kg body weight) during each interval during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
8. Exercise Training Intensity: Time spent at Maximal 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 change in the time (min:sec) spent at 0-50%, 50-65%, 65-75%, 75-90%, >90% of maximal work rate during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
9. 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 changes in the average heart rate (bpm) during each 40 minute exercise training session, performed on a stationary bike, over 12 weeks.
10. 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 change in the time (min:sec) 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.
11. Hemoglobin mass
[ Time Frame: Measured at Baseline and week 15. ]

To measure changes from baseline of Hemoglobin mass (g), measured with the carbon monoxide-rebreathing method.
12. Red blood cell volume
[ Time Frame: Measured at Baseline and week 15. ]

To measure changes from baseline of Red blood cell volume (mL), measured with the carbon monoxide-rebreathing method.
13. Plasma volume
[ Time Frame: Measured at Baseline and week 15. ]

To measure changes from baseline of Plasma volume (mL), measured with the carbon monoxide-rebreathing method.
14. Total blood volume
[ Time Frame: Measured at Baseline and week 15. ]

To measure changes from baseline of total blood volume (mL), measured with the carbon monoxide-rebreathing method.
15. 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.
16. Ventilation
[ Time Frame: Measured at Baseline, at week 1, and at week 15. ]

To measure changes from baseline of ventilation (L/min) at VO2max.
17. Respiratory rate
[ Time Frame: Measured at Baseline, at week 1, and at week 15. ]

To measure changes from baseline of respiratory rate (breaths per minute) at VO2max.
18. VCO2
[ Time Frame: Measured at Baseline, at week 1, and at week 15. ]

To measure changes from baseline of VCO2 (L/min) at VO2max.
19. Respiratory exchange ratio
[ Time Frame: Measured at Baseline, at week 1, and at week 15. ]

To measure changes from baseline of the respiratory exchange ratio (VCO2/VO2) at VO2max
20. Rating of Perceived Capacity
[ Time Frame: Measured at Baseline, at week 1, and at week 15. ]

To measure changes from baseline of the 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.
21. Rating of Perceived Exertion
[ Time Frame: Measured at Baseline, at week 1, and at week 15. ]

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.
22. 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.
23. 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)
24. Daily Physical Activity: Number of steps per day
[ Time Frame: Measured daily, from study enrollment for 16 weeks. ]

To measure changes from baseline in the cumulative number of steps per day, derived from a mobile health device (Garmin VivoFit).
25. Daily Physical Activity: Sedentary Time (minutes per day)
[ Time Frame: Measured daily, from study enrollment for 16 weeks. ]

To measure changes from baseline in the number of sedentary minutes per day, derived from a mobile health device (Garmin VivoFit).
26. Daily Physical Activity: Sedentary Time (percentage)
[ Time Frame: Measured daily, from study enrollment for 16 weeks. ]

To measure changes from baseline in the daily % of time sedentary, derived from a mobile health device (Garmin VivoFit).
27. Daily Physical Activity: ActiveTime (minutes per day)
[ Time Frame: Measured daily, from study enrollment for 16 weeks. ]

To measure changes from baseline in the number of active minutes per day, derived from a mobile health device (Garmin VivoFit).
28. Daily Physical Activity: ActiveTime (percentage)
[ Time Frame: Measured daily, from study enrollment for 16 weeks. ]

To measure changes from baseline in the daily % of time active, derived from a mobile health device (Garmin VivoFit).
29. Daily Physical Activity: Very ActiveTime (minutes per day)
[ Time Frame: Measured daily, from study enrollment for 16 weeks. ]

To measure changes from baseline in the number of very active minutes per day, derived from a mobile health device (Garmin VivoFit).
30. Daily Physical Activity: Very ActiveTime (percentage)
[ Time Frame: Measured daily, from study enrollment for 16 weeks. ]

To measure changes from baseline in the daily % of time very active, derived from a mobile health device (Garmin VivoFit).
31. High density lipoprotein (HDL)
[ Time Frame: Measured at Baseline, week 6, week 10, and week 15. ]

To measure changes from baseline of HDL concentrations in serum (mg/dL).
32. Low density lipoprotein (LDL)
[ Time Frame: Measured at Baseline, week 6, week 10, and week 15. ]

To measure changes from baseline of LDL concentrations in serum (mg/dL).
33. Very low density lipoprotein (VLDL)
[ Time Frame: Measured at Baseline, week 6, week 10, and week 15. ]

To measure changes from baseline of VLDL concentrations in serum (mg/dL).
34. High Sensitivity C-reactive protein (hs-CRP)
[ Time Frame: Measured at Baseline, week 6, week 10, and week 15. ]

To measure changes from baseline of hs-CRP concentrations in serum (mg/dL).
35. Growth Hormone
[ Time Frame: Measured at Baseline, week 6, week 10, and week 15. ]

To measure changes from baseline of growth hormone concentrations in serum (ng/mL).
36. Hemoglobin A1c (HbA1c)
[ Time Frame: Measured at Baseline, week 6, week 10, and week 15. ]

To measure changes from baseline of platelet count and glycosylated hemoglobin (HbA1c in whole blood).
37. Resting Blood Pressure
[ Time Frame: Measured at Baseline, week 6, week 10, and week 15. ]

To measure changes from baseline of resting blood pressure in mmHg.
38. Resting Heart Rate
[ Time Frame: Measured at Baseline, week 6, week 10, and week 15. ]

To measure changes from baseline of resting heart rate in bpm.
39. Body Fat
[ Time Frame: Measured at Baseline, at week 1, and at week 15. ]

To measure changes from baseline of body fat, measured as a percentage.
40. Waist circumference
[ Time Frame: Measured at Baseline, at week 1, and at week 15. ]

To measure changes from baseline of waist circumference measured in cm.
41. Body weight
[ Time Frame: Measured at each visit, starting from Baseline until week 15. ]

To measure changes from baseline of body weight measured in kg.
42. Exhaled carbon monoxide
[ Time Frame: Measured at each visit, starting from Baseline until week 15. ]

To measure changes from baseline of exhaled carbon monoxide (ppm).
43. Carboxyhemoglobin
[ Time Frame: Measured at Baseline, week 1, week 6, week 10, and week 15. ]

To measure changes from baseline of Carboxyhemoglobin (COHb), assayed from whole blood. Expressed as % of saturation of hemoglobin.
44. NEQ
[ Time Frame: Measured at Baseline, week 1, week 6, week 10, and week 15. ]

To measure changes from baseline of Nicotine equivalents (NEQ) concentrations, measured in urine and expressed as concentration adjusted for creatinine.
45. Total NNAL
[ Time Frame: Measured at Baseline, week 1, week 6, week 10, and week 15. ]

To measure changes from baseline of Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentrations, measured in urine and expressed as concentration adjusted for creatinine.
46. CEMA
[ Time Frame: Measured at Baseline, week 1, week 6, week 10, and week 15. ]

To measure changes from baseline of 2-cyanoethylmercapturic acid (CEMA) concentrations, measured in urine and expressed as concentration adjusted for creatinine.
47. Nicotine/Tobacco product use
[ Time Frame: Recorded daily by subject, in product use diary, from study enrollment for 16 weeks. ]

To measure changes in self-reported number of any nicotine/tobacco product used on a daily basis.
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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).
Open or close this module Contacts/Locations
Study Officials: Armin Schultz, MD
Principal Investigator
CRS Clinical Research Services Mannheim GmbH
Christelle Haziza, PhD
Study Chair
Philip Morris Products S.A.
Locations: Germany
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany, D-68167
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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