To evaluate selected biomarkers of tobacco exposure and biomarkers of harm and assess quality of life measures in smokers randomly switched from their usual brand of cigarette to one of three test products: (1) a tobacco-heating cigarette; (2) snus (smokeless tobacco); or (3) an ultra-low machine yield tobacco-burning cigarette.
A randomized, multi-center, 4-group study of health status measures and biomarkers in subjects who smoke and are switched to either a tobacco-heating cigarette, snus, or a tobacco-burning cigarette, with a non-treatment group of never-smokers. Primary Objectives: * Evaluate select biomarkers of tobacco exposure and biomarkers of harm from subjects who smoke and who are switched to a tobacco-heating cigarette, snus, or a tobacco-burning cigarette. * Evaluate ability of a tobacco-heating cigarette and snus to modify patient-reported Chronic Obstructive Pulmonary Disease (COPD)-related health status in subjects who smoke and are switched to either a tobacco-heating cigarette or snus relative to a control group (a tobacco-burning ultra-low machine yield \[ULMY\]) cigarette. * Assess subject compliance. Secondary Objectives: * Measure amount and repeatability of smoke components yielded from the cigarettes (yield in use) and determine relative uptake of selected smoke components. * Evaluate the ability of a tobacco-heating cigarette and snus to modify general health status as measured by self-administered health questionnaires in subjects who smoke and are switched to either a tobacco-heating cigarette or snus relative to a control group (a tobacco-burning ULMY cigarette). * Compare health status measures in smokers who are switched to a tobacco-heating cigarette to smokers who are switched to snus. * Compare baseline data from all tobacco-using groups to baseline data from the never-smoking (non-treatment) group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
163
Smokers switched to a tobacco-heating cigarette for 24 weeks
Smokers switched to snus product for 24 weeks
Smokers switched to a tobacco-burning cigarette for 24 weeks
Covance Clinical Research Unit, Inc.
Daytona Beach, Florida, United States
Covance Clinical Research Unit, Inc.
Boise, Idaho, United States
Covance Clinical Research Unit, Inc.
Portland, Oregon, United States
Covance Clinical Research Unit, Inc.
Austin, Texas, United States
Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 12
Nicotine and nine metabolites, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, benzene, isoprostanes, and urine mutagenicity
Time frame: Week 12
Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 12
Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin
Time frame: Week 12
Change in Markers of Exposure and Potential Harm from Weeks 0 to 12
Exhaled carbon monoxide and spirometry
Time frame: Week 12
Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 12
St. George's Respiratory Questionnaire and Leicester Cough Questionnaire
Time frame: Week 12
Change in tobacco usage diary from Weeks 0 to 4
Time frame: Week 4
Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 24
Nicotine and nine metabolites, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, aromatic amines, benzene, isoprostanes, and urine mutagenicity
Time frame: Week 24
Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 24
Lipid/cardiac risk markers, hypercoagulable state markers, endothelial function, DNA damage, and carboxyhemoglobin
Time frame: Week 24
Change in Markers of Exposure and Potential Harm from Weeks 0 to 24
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Covance Clinical Research Unit, Inc.
Dallas, Texas, United States
Exhaled carbon monoxide and spirometry
Time frame: Week 24
Change in daily tobacco usage diary from Weeks 4 to 8
Time frame: Week 8
Change in daily tobacco usage diary from Weeks 8 to 12
Time frame: Week 12
Change in daily tobacco usage diary from Weeks 12 to 16
Time frame: Week 16
Change in daily tobacco usage diary from Weeks 16 to 20
Time frame: Week 20
Change in daily tobacco usage diary from Weeks 20 to 24
Time frame: Week 24
Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 24
St. George's Respiratory Questionnaire and Leicester Cough Questionnaire
Time frame: Week 24
Change in Nicotine Yield versus Uptake from Weeks 0 to 12
Mouth-level exposure to tar and nicotine
Time frame: Week 12
Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 12
Smoking Cessation Quality of Life Questionnaire (inclusive of the SF-36 v2)
Time frame: Week 12
Change in Nicotine Yield versus Uptake from Weeks 0 to 24
Mouth-level exposure to tar and nicotine
Time frame: Week 24
Change in health status scores from self-administered questionnaires on general health from Weeks 0 to 24
Smoking Cessation Quality of Life Questionnaire (inclusive of the SF-36 v2)
Time frame: Week 24