Table 1.
Demographics and mean pre-treatment measurements for all study subjects
| Study (total N) | CS01 (33) | CS02 (12) | CS04 (37)a |
|---|---|---|---|
| Age, mean (SD) years | 27.9 (9.5) | 36.5 (9.7) | 34.4 (9.3) |
| Sex, male n (%) | 20 (61) | 10 (83) | 22 (59) |
|
Race, n (%) Whiteb |
30 (91) | 10 (83) | 11 (30) |
| Black | 2 (6) | 2 (17) | 24 (65) |
| Asian | 0 (0) | 0 (0) | 1 (3) |
| Other | 1 (3) | 0 (0) | 1 (3) |
| Body weight, mean (SD) kg | 77.6 (14.7) | 83.1 (15.7) | 77.7 (13.8) |
| BMI, mean (SD) kg/m2 | 24.9 (3.2) | 26.3 (2.3) | 26.1 (3.5) |
| Venous MetHb, mean (SD) (%) | 0.52 (0.10) | 0.70 (0.17) | 1.1 (0.5)c |
| Systolic BP, mean (SD) mmHgd | 116 (12) | 120 (19) | 114 (13) |
| Diastolic BP, mean (SD) mmHgd | 63.7 (7.4) | 64.5 (12.8) | 66.7 (7.4) |
| MAP, mean (SD) mmHgd | 81.0 (7.6) | 83.4 (14.1) | 82.4 (8.2) |
| Heart rate, mean (SD) bpmd | 69.2 (9.6) | 81.7 (16.3) | 70.5 (12.1) |
| Plasma nitrite (NO2 −) via liquid chomatography-fluorometric assay | |||
| Percent quantifiable | 51.5 % | 77.3 % | 0 %d,e |
| Mean of quantifiable (SD) µmol/L | 0.612 (0.098) | 0.809 (0.208) | BLQ |
| Plasma nitrite; mean (SD) µmol/Lf | nd | nd | 0.107 (0.100) |
| Plasma nitrate; mean (SD) µmol/Lf | nd | nd | 21.9 (7.2) |
| Fraction exhaled NO; mean (SD) ppb | 14.8 (7.7) | nd | 17.0 (8.0) |
BLQ below the limit of quantification, BMI body mass index, BP blood pressure, DBP diastolic blood pressure, MAP mean arterial pressure, MetHb methemoglobin, nd not determined, NO nitric oxide, SD standard deviation, SBP systolic blood pressure
aIncluding placebo treated subjects in Parts A and B of study CS04
bIncluding Latino subjects
c n = 27; pre-study venous methemoglobin data not available for 10 subjects
dSupine vital signs measured immediately prior to first sodium nitrite inhalation; MAP = DBP + 1/3(SBP − DBP)
ePre-dose plasma nitrite BLQ of liquid chromatography-fluorometric assay in all subjects in study CS04
fPre-dose plasma nitrite and nitrate determined via chemiluminescence assay in Part A of study CS04 only (n = 28)