Primary endpoints | |
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Biomarkers of exposure | |
• Urine: Nicotine, cotinine, 3-hydroxycotinine and their glucuronide conjugates, acrolein metabolite (3-HPMA), crotonaldehyde metabolite (HMPMA), TSNA metabolites (total NNAL, total NNN, total NAT, total NAB), 1,3-butadiene metabolite (MHBMA), acrylonitrile metabolite (CEMA) and aromatic amines (4-aminobiphenyl, 3-aminobiphenyl, o-toluidine, 2-aminonaphthalene), plus 9 PAH metabolites (1-Hydroxynapthalene, 2-Hydroxynapthalene, 2-Hydroxyflourene, 1-, 2-, 3-, 4, and 9-Hydroxyphenanthrene, 1-Hydroxypyrene) | |
• Salivary cotinine | |
• Exhaled CO | |
Biomarkers of biological effect: | |
• Urine: F2-isoprostane (8-iso-PGF2 Type III and VI; for oxidative stress) | |
• Blood: white blood cells (for cardiovascular disease) | |
• Plasma: sICAM-1 (for cardiovascular disease) | |
Secondary endpoints | |
Biomarkers of exposure | |
• Urine: urine mutagenicity (Ames test) | |
Biomarkers of biological effect | |
• Urine: 8-OHdG, cis-thymidine glycol, 11-dehydrothromboxane B2 | |
• Blood: gene expression, neutrophil count, monocyte count | |
• Erythrocytes: haemoglobin, superoxide dismutase activity, glutathione peroxidase, glutathione reductase, catalase activity, malondialdehyde | |
• Plasma or serum: IL-6, IL-8, ascorbic Acid, dehydroascorbic Acid, total antioxidant capacity, hsCRP (males), fasting (12 h) lipid profile (total cholesterol, LDL, HDL, Triglycerides), fibrinogen, MCP-1, neutrophil elastase, MMP-1, MMP-9, TIMP-1, LTB4, TNF-α, VEGF, oxLDL | |
Other features | |
• Filter analysis: MLE to nicotine and ‘tar’ (nicotine-free dry particulate matter [NFDPM]) | |
• Sensory testing questionnaire | |
• QoL questionnaire | |
• Smoking behaviours questionnaire | |
• Puffing and inhalation behaviour | |
• Pulmonary function test (FEV, FEV1, PEF) | |
• Biomarkers of Effective Dose (compliance monitoring) | |
• Haemoglobin adducts in blood: Acrylonitrile (2-Cyanoethylvaline) and 4-ABP |