Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks

Completed · Not applicable

Conditions studied: Smoking

In brief

The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period. To characterize the study as successful, at least 5 clinical risk endpoints should move in the direction of smoking cessation and these results would be statistically significant. The main analysis will be defined a priori (using the Hailperin-Ruger approach) and will be made between THS 2.2 use and CC use as "per actual product used" and product use categories.

Key facts

Study ID

NCT02396381

Run by

Philip Morris Products S.A.

People needed

1039

Starts

2015-03-12

Expected to finish

2017-08-01

Last updated by the study team

2023-01-26

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Current healthy smoker as judged by the Principal Investigator(s) or designee(s)
• Minimum age: 30 years old
• Have smoked for the last 10 years
• Have smoked more than 10 non menthol CC/day on average (no brand restriction) over the past year

You may not qualify if…

• Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
• Subject who has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator spirometry
• Subject with asthma condition (post-bronchodilator FEV1/FVC < 0.75 and reversibility in FEV1 ≥ 12% and > 200 mL from pre- to post-bronchodilator values)
• Subject who took or is taking concomitant medication which may have an impact on the "smoker's heath profile"
• Female subject is pregnant or breast feeding.
• Female subject who does not agree to use an acceptable method of effective contraception.

Where it is running

• Celerion Arizona — Tempe, Arizona, United States
• Clinical Research West Florida — Clearwater, Florida, United States
• Covance, Inc — Daytona Beach, Florida, United States
• Compass Research — Orlando, Florida, United States
• Clinical Research West Florida — Tampa, Florida, United States
• Compass Research — The Villages, Florida, United States
• Central Kentucky Research Associate — Lexington, Kentucky, United States
• Celerion Lincoln — Lincoln, Nebraska, United States
• PMG Research of Cary — Cary, North Carolina, United States
• PMG Research of Charlotte — Charlotte, North Carolina, United States
• PMG Research of Raleigh — Raleigh, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• PMG Research of Bristol — Bristol, Tennessee, United States
• NOCCR — Knoxville, Tennessee, United States
• Benchmark — Austin, Texas, United States
• Benchmark — Fort Worth, Texas, United States
• Benchmark — San Angelo, Texas, United States
• National Clinical Research — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.