This trial has been completed.

Condition smoking
Treatments ths 2.2, cc
Sponsor Philip Morris Products S.A.
Start date March 2015
End date August 2016
Trial size 984 participants
Trial identifier NCT02396381, ZRHR-ERS-09-US


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Ad libitum use of THS 2.2
ths 2.2
Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks
(Active Comparator)
Ad libitum use of CC
Ad libitum use of CC in an ambulatory setting for 26 weeks

Primary Outcomes

Levels of high density lipoprotein C (HDL-C).
time frame: 26 Weeks
Levels of white blood cells (WBC).
time frame: 26 Weeks
Post-bronchodilator forced expiratory volume in 1 second (FEV1).
time frame: 26 Weeks
Concentrations of soluble intercellular adhesion molecule 1 (sICAM-1).
time frame: 26 Weeks
Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).
time frame: 26 Weeks
Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).
time frame: 26 Weeks
Concentrations of total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL).
time frame: 26 Weeks
Levels of carboxyhemoglobin (COHb).
time frame: 26 Weeks

Eligibility Criteria

Male or female participants at least 30 years old.

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.

Additional Information

Official title A Randomized, Controlled, 2-arm Parallel Group, Multi-center Study, to Evaluate Biological and Functional Changes in Healthy Smokers Switching to Tobacco Heating System 2.2 (THS 2.2) Compared to Continuing Smoking Conventional Cigarettes for 26 Weeks in an Ambulatory Setting
Principal investigator Danielle Armas, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Philip Morris Products S.A..