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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,039
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
...and 9 more locations
Levels of High Density Lipoprotein C (HDL-C).
Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.
Time frame: 26 Weeks
Levels of White Blood Cells (WBC).
Concentrations measured in blood. Geometric Least Squares means are provided as descriptive statistics.
Time frame: 26 Weeks
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).
FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Geometric Least Squares means are provided as descriptive statistics.
Time frame: 26 Weeks
Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).
Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.
Time frame: 26 Weeks
Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).
Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Time frame: 26 Weeks
Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).
Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Time frame: 26 Weeks
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).
Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Time frame: 26 Weeks
Percent Change From Baseline of Carboxyhemoglobin (COHb)
Carboxyhemoglobin (COHb) is assayed from whole blood. Geometric Least Squares means are provided as descriptive statistics. Expressed as % of saturation of hemoglobin.
Time frame: 26 Weeks
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