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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	IQOS + Exercise Training Program	Switch to IQOS use + participation in a training program
OTHER	IQOS without Exercise Training Program	Switch to IQOS use only, without participation in a training program
OTHER	Cigarette Smoking + Exercise Training Program	Continue to smoke cigarettes + participation in a training program
OTHER	Smoking Abstinence + Exercise Training Program	Switch to smoking abstinence + participation in a training program

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-11-25
• Completion: 2020-03-16
• First posted: 2019-03-22
• Last updated: 2021-12-27
• Results posted: 2021-12-27

Locations

1 site across 1 country: Germany