- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887117
Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mannheim, Germany, D-68167
- CRS Clinical Research Services Mannheim GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Switch to IQOS use + participation in a training program
|
Active Comparator: IQOS-2
IQOS without Exercise Training Program Subjects randomized to IQOS use will switch to IQOS use, but will not participate in an exercise training program. |
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. |
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. |
Switch to smoking abstinence + participation in a training program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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]).
|
Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
|
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).
|
Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
|
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]).
|
Measured at baseline (V3), at week 1 (V4), and at week 12 (V43).
|
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).
|
Measured at baseline (V3), at week 1 (V4), and at week 12 (V43)
|
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.
|
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
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.
|
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
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.
|
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
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.
|
Measured during 38 exercise training sessions of 40 minutes duration, conducted approximately 3 times a week, 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.
|
Measured at Baseline (V3) and week 12 (V43).
|
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.
|
Measured at Baseline (V3) and week 12 (V43).
|
Plasma Volume
Time Frame: Measured at Baseline (V3) and week 12 (V43).
|
To measure Plasma volume (mL), measured with the carbon monoxide-rebreathing method.
|
Measured at Baseline (V3) and week 12 (V43).
|
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.
|
Measured at Baseline (V3) and week 12 (V43).
|
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.
|
Measured at Baseline and week 15.
|
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.
|
Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
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.
|
Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
VCO2
Time Frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
To measure VCO2 (L/min) at VO2 max.
|
Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
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
|
Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
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.
|
Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
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.
|
Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
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.
|
Measured at Baseline, at week 1, and at week 15.
|
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)
|
Measured at Baseline, at week 1, and at week 15.
|
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).
|
Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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).
|
Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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).
|
Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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).
|
Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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).
|
Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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).
|
Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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.
|
Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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.
|
Measured at Baseline (V3), week 6 (V14), week 10 (V28), and week 12 (V43).
|
Body Fat
Time Frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
To measure body fat as a percentage.
|
Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
Waist Circumference
Time Frame: Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
To measure waist circumference in cm.
|
Measured at Baseline (V3), at week 1 (V4), and at week 12 (V43).
|
Body Weight
Time Frame: Measured at each visit, starting from Baseline (V3) until week 12 (V43).
|
To measure body weight in kilograms.
|
Measured at each visit, starting from Baseline (V3) until week 12 (V43).
|
Exhaled Carbon Monoxide
Time Frame: Measured at each visit, starting from Baseline (V3) until week 12 (V43).
|
To measure exhaled carbon monoxide (ppm).
|
Measured at each visit, starting from Baseline (V3) until week 12 (V43).
|
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.
|
Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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.
|
Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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.
|
Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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.
|
Measured at Baseline (V3), week 1 (V4), week 6 (V14), week 10 (V28), and week 12 (V43).
|
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.
|
Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
|
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.
|
Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
|
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.
|
Recorded daily by subject, in product use diary, from study enrollment for 16 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Armin Schultz, MD, CRS Clinical Research Services Mannheim GmbH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P1-EXC-01-EU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
University of VirginiaRecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking, Cigarette | Quitting SmokingUnited States
-
Columbia UniversityNational Cancer Institute (NCI)RecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking BehaviorsUnited States
-
National Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Cigarette Smoking | Tobacco, SmokingUnited States
-
University GhentRecruitingSmoking | Smoking Tobacco | Smoking Prevention | Smoking CigaretteBelgium
-
Medical University of South CarolinaCompletedSmoking | Smoking Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Maastricht University Medical CenterThe Investigative Desk; SEO Amsterdam Economics; IVO Research InstituteEnrolling by invitationSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsNetherlands
-
Jennifer Marler, MDCompletedSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsUnited States
-
Medical University of South CarolinaRecruitingSmoking | Smoking Cessation | Tobacco Smoking | Cigarette SmokingUnited States
-
Ghana Health ServicesKwame Nkrumah University of Science and TechnologyNot yet recruitingSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking Behaviors
Clinical Trials on IQOS + Exercise Training Program
-
Riphah International UniversityCompleted
-
Universidad Pablo de OlavideUniversity of SevilleCompletedObesity | Overweight and Obesity | Overweight or ObesitySpain
-
University of FloridaRecruitingStrokeUnited States
-
Chang Gung Memorial HospitalCompletedModerate to Severe COPD Receiving Home Exercise TrainingTaiwan
-
University of Illinois at ChicagoRecruitingMultiple SclerosisUnited States
-
Universidade Federal de Sao CarlosCompletedChronic Obstructive Pulmonary Disease (COPD)Brazil
-
Dana-Farber Cancer InstituteBreast Cancer Research FoundationNot yet recruitingBreast Cancer | Breast Cancer FemaleUnited States
-
Imam Abdulrahman Bin Faisal UniversityCompletedSickle Cell DiseaseSaudi Arabia
-
Centro Hospitalar do PortoUniversidade do Porto; Aveiro UniversityCompleted
-
Istanbul University - Cerrahpasa (IUC)CompletedChronic Low-back PainTurkey