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

Philip Morris

Status

Completed

Conditions

Smoking

Treatments

Other: CC

Other: THS 2.2

Study type

Interventional

Funder types

Industry

Identifiers

NCT02396381

ZRHR-ERS-09-US (Other Identifier)

Details and patient eligibility

About

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.

Full description

The clinical, biological and functional endpoints to be measured in this study ("smoker's health profile") may characterize the modification of risk of smoking-related diseases.

Clinical risk endpoint to be assessed are selected based on a) their association to smoking-related diseases b) their association to smoking status, c) their reversibility upon smoking cessation, and d) their suitability to be measured with valid and robust methods in clinical studies.

The biological markers, functional markers and biomarkers of exposure (BoExp) with the strongest scientific evidence will constitute the 'smoker's health profile' and will be measured as the primary objective of the study.

Additional endpoints involved in the mechanistic of smoking-related diseases will be studied to provide additional scientific evidence to strengthen the primary objective.

The study will provide a perspective of product usage in a "real world setting" where smoking CC in addition to THS 2.2 may be expected.

Enrollment

1,039 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.