Table 4.

Mean change in tobacco smoke adduct levels by study arm

400 mg200 mgPlacebo
PAH-DNA in lung epithelial cells (endobronchial biopsies) by immunoperoxidase (mean relative staining intensity)
    Mean−0.0040.0010.001
    SD0.0420.0310.045
    n171721
BPDE-hemoglobin in blood by tandem mass spectrometry; benzo(a)pyrene-tetraol in sample (fmol/mg globin)*
    Mean0.0020−0.00040.0910
    SD0.00700.00400.3226
    n161214
PAH-DNA in PBMCs by ELISA (adducts per 108 DNA bases)
    Mean−0.467−0.028−0.125
    SD1.2761.3910.495
    n141013
PAH-DNA in oral rinse cytospins by immunoperoxidase (mean relative staining intensity)
    Mean−0.0250.014−0.022
    SD0.0530.0680.083
    n151115
PAH-DNA in urine cytospins by immunoperoxidase (mean relative staining intensity)
    Mean−0.023−0.000−0.026
    SD0.1020.0850.072
    n15913
  • * Samples with adduct levels below the limit of detection were assigned values of 0. Excluding these values or assigning a value of half of the limit of detection also did not result in significant difference between the drug arms and placebo.