Table 1 Baseline demographics and clinical characteristics (ITT population)
Revefenacin | ||||||
|---|---|---|---|---|---|---|
Placebo (n = 70) | 44 μg (n = 68) | 88 μg (n = 71) | 175 μg (n = 71) | 350 μg (n = 74) | Total (N = 354) | |
Age (years) | ||||||
Mean (SD) | 62.2 (9.17) | 60.9 (8.87) | 60.4 (7.98) | 64.5 (7.69) | 61.4 (8.98) | 61.9 (8.63) |
Sex (%) | ||||||
Male | 37 (52.9) | 32 (47.1) | 32 (45.1) | 37 (52.1) | 40 (54.1) | 178 (50.3) |
Female | 33 (47.1) | 36 (52.9) | 39 (54.9) | 34 (47.9) | 34 (45.9) | 176 (49.7) |
Race (%) | ||||||
White | 65 (92.9) | 63 (92.6) | 64 (90.1) | 65 (91.5) | 67 (90.5) | 324 (91.5) |
Black/African American | 4 (5.7) | 4 (5.9) | 6 (8.5) | 5 (7.0) | 6 (8.1) | 25 (7.1) |
Other | 1 (1.4) | 1 (1.5) | 1 (1.4) | 1 (1.4) | 1 (1.4) | 5 (1.4) |
BMI (kg/m2) | ||||||
Mean (SD) | 27.6 (5.73) | 27.9 (6.87) | 27.0 (5.92) | 28.0 (5.30) | 29.0 (5.76) | 27.9 (5.93) |
Current smoker (%) | ||||||
Yes | 35 (50.0) | 40 (58.8) | 44 (62.0) | 33 (46.5) | 38 (51.4) | 190 (53.7) |
Smoking duration (pack-years) | ||||||
Mean (SD) | 38.2 (9.71) | 39.3 (11.59) | 38.9 (10.16) | 41.2 (10.01) | 39.6 (9.04) | 39.5 (10.11) |
Current ICS use (%) | ||||||
Yes | 29 (41.4) | 25 (36.8) | 24 (33.8) | 26 (36.6) | 26 (35.1) | 130 (36.7) |
Pre-dose FEV1 (mL) | ||||||
Mean (SD) | 1205.0 (473.00) | 1279.0 (470.10) | 1321.0 (441.58) | 1267.2 (415.67) | 1338.8 (483.95) | 1282.6 (457.25) |
Pre-dose FEV1/FVC (%) | ||||||
n | 70 | 68 | 71 | 71 | 72 | 352 |
Mean (SD) | 0.50 (0.11) | 0.51 (0.11) | 0.52 (0.09) | 0.51 (0.10) | 0.52 (0.09) | 0.51 (0.10) |
Percent predicted post-bronchodilator FEV1 (%) | ||||||
n | 70 | 68 | 71 | 71 | 72 | 352 |
Mean (SD) | 41.2 (13.00) | 43.0 (13.35) | 45.1 (12.43) | 44.0 (11.76) | 44.5 (12.35) | 43.6 (12.58) |