Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity

NCT ID: NCT03887117

Last Updated: 2021-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-03-16

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.

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

Keywords

IQOS; Heated Tobacco

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

IQOS-1

IQOS + Exercise Training Program

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

Group Type: ACTIVE_COMPARATOR

IQOS + Exercise Training Program

Intervention Type: OTHER

Switch to IQOS use + participation in a training program

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.

Group Type: ACTIVE_COMPARATOR

IQOS without Exercise Training Program

Intervention Type: OTHER

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

Cigarette Smoking

Cigarette Smoking + Exercise Training Program

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

Group Type: ACTIVE_COMPARATOR

Cigarette Smoking + Exercise Training Program

Intervention Type: OTHER

Continue to smoke cigarettes + participation in a training program

Smoking Abstinence

Smoking Abstinence + Exercise Training Program

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

Group Type: ACTIVE_COMPARATOR

Smoking Abstinence + Exercise Training Program

Intervention Type: OTHER

Switch to smoking abstinence + participation in a training program

Interventions

IQOS + Exercise Training Program

Switch to IQOS use + participation in a training program

Intervention Type: OTHER

IQOS without Exercise Training Program

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

Intervention Type: OTHER

Cigarette Smoking + Exercise Training Program

Continue to smoke cigarettes + participation in a training program

Intervention Type: OTHER

Smoking Abstinence + Exercise Training Program

Switch to smoking abstinence + participation in a training program

Intervention Type: OTHER

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philip Morris Products S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Armin Schultz, MD

Role: PRINCIPAL_INVESTIGATOR

CRS Clinical Research Services Mannheim GmbH

Christelle Haziza, PhD

Role: STUDY_CHAIR

Philip Morris Products S.A.

Locations

CRS Clinical Research Services Mannheim GmbH

Mannheim, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P1-EXC-01-EU

Identifier Type: -

Identifier Source: org_study_id