Table 2.
Industry measures and instruments to assess exposure and health indicators in human subjects.
| Measures | Biomarkers or Outcomes of interest | Examples of Products Assessed |
|---|---|---|
| Physiological Measures | ||
| Heart rate; Skin temperature; Blood pressure; Body weight (9) |
Risk of cardiovascular, renal, and other diseases |
Accord, Eclipse, denicotinized cigarette, conventional cigarette |
| Blood (8–11,18,32,33,35) |
Biomarkers of Exposure: Nicotine metabolites; Carboxyhemoglobin; Nitrosamine adducts (NNK); PAH adducts; Aromatic/heterocyclic amine adducts (e.g., 4-ABP); Aldehyde adducts; Volatile hydrocarbon adducts and metabolites; Organic compound adducts (e.g, ethylene oxide); Biomarkers of Effect: White blood cell count; Cell differential; Platelet count; % lymphocytes; % neutrophils; % monocytes; C-reactive protein (blood serum) Fibrinogen (blood plasma) |
Accord, Eclipse, denicotinized cigarette, conventional cigarette |
| Exhaled air(35) |
Biomarkers of Exposure: Carbon monoxide; Biomarkers of Effect: H2O2 in exhaled breath condensate; Airway nitric oxide (measure of airway inflammation) |
Accord, Eclipse,denicotinized cigarette, conventional cigarette |
| Urine(30,35) |
Biomarkers of Exposure: Nicotine metabolites; Nitrosamine metabolites (NNK); PAH metabolites; Urine mutagenicity Biomarkers of Effect:: DNA adducts |
Accord, Eclipse, denicotinized cigarette, conventional cigarette |
| Cardiopulmonary Exercise Testing(13) |
Exercise capacity/perceived exertion | Accord vs. Light conventional cigarette |
| Bronchoscopic inspection(30) | Lower respiratory tract inflammation | Eclipse use among regular smokers |
| Smoking Behavior | ||
| Smoking Behavior Questionnaire(45) |
Smoking activities (a) 2 days before and (b) same day of biomarker collection |
Accord vs. Ultra Light conventional cigarette |
| Subjective Measures | ||
| Product Assessment Questionnaire(45) |
Subject’s rating of cigarette attributes | Accord vs. Ultra Light conventional cigarette |
| Fagerstrom Questionnaire(44) | Nicotine dependence | Accord vs. Ultra Light conventional cigarette; Accord vs. Light conventional cigarette |
| Diet, Consumption, and Physical Activity Questionnaire(31) |
Level of physical fitness, exposure from food |
Accord, Eclipse, denicotinized cigarette, conventional cigarette |