Table 1 Baseline patient demographics and clinical characteristics (ITT population)
Characteristic | Revefenacin 88 μg (n = 350) | Revefenacin 175 μg (n = 319) | Tiotropium 18 μg (n = 351) |
|---|---|---|---|
Age, y, mean (SD) | 64.2 (9.37) | 64.5 (8.61) | 64.9 (8.91) |
Sex, male, n (%) | 197 (56.3) | 188 (58.9) | 211 (60.1) |
Race, white, n (%) | 324 (92.6) | 294 (92.2) | 326 (92.9) |
BMI, kg/m2, mean (SD) | 28.9 (6.6) | 29.0 (6.6) | 28.8 (6.3) |
Current smoker, n (%) | 163 (46.6) | 140 (43.9) | 164 (46.7) |
Concurrent COPD medication use, n (%) | |||
ICS | 191 (54.6) | 165 (51.7) | 187 (53.3) |
LABA or ICS/LABA | 175 (50.0) | 158 (49.5) | 177 (50.4) |
ICS/LABA | 170 (48.6) | 146 (45.8) | 172 (49.0) |
COPD duration, y, mean (SD) | 9.3 (6.98) | 8.7 (5.92) | 9.5 (6.84) |
2011 GOLDa category, n (%) | |||
A | 31 (8.9) | 20 (6.3) | 23 (6.6) |
B | 184 (52.6) | 165 (51.7) | 183 (52.1) |
C | 7 (2.0) | 7 (2.2) | 5 (1.4) |
D | 128 (36.6) | 123 (38.6) | 136 (38.7) |
Unknown | 0 | 4 (1.3) | 4 (1.1) |
2011 GOLDa airflow limitation category, n (%) | |||
2 | 222 (61.0) | 201 (60.0) | 210 (59.0) |
3 | 122 (33.5) | 109 (32.5) | 124 (34.8) |
4 | 20 (5.5) | 25 (7.5) | 22 (6.2) |
Postipratropium percent predicted FEV1, %, mean (SD) | 54.29 (14.1) | 53.75 (14.8) | 53.15 (14.2) |
Postipratropium FEV1 to FVC ratio, mean (SD) | 0.54 (0.10) | 0.53 (0.10) | 0.53 (0.10) |
Baseline FEV1, L, mean (SD) | 1.34 (0.5) | 1.34 (0.5) | 1.32 (0.5) |
Proportion of patients with baseline mMRC ≥ 2, n (%) | 181 (51.7) | 170 (53.3) | 180 (51.3) |
Proportion of patients with baseline CAT ≥ 10, n (%) | 312 (89.1) | 288 (90.3) | 319 (90.9) |
Number of COPD exacerbations in prior year, n (%) | |||
0 | 264 (75.4) | 242 (75.9) | 271 (77.2) |
1 | 59 (16.9) | 50 (15.7) | 52 (14.8) |
≥ 2 | 27 (7.7) | 27 (8.5) | 28 (8.0) |