Table 2 Screening demographics and characteristics for FEV1 percent predicted subgroups (ITT population).
Predicted FEV1 at screening <50% N = 415 | Predicted FEV1 at screening ≥50% N = 380 | |||
|---|---|---|---|---|
FF/UMEC/VI | TIO | FF/UMEC/VI | TIO | |
n = 212 | n = 203 | n = 185 | n = 195 | |
Age, years, mean (SD) | 65.9 (8.02) | 65.2 (7.44) | 66.7 (8.16) | 67.0 (8.05) |
Male, n (%) | 149 (70) | 129 (64) | 123 (66) | 139 (71) |
BMI, kg/m2, mean (SD) | 27.4 (6.4) | 27.0 (5.8) | 27.6 (5.7) | 27.4 (4.8) |
Current smoker at screening, n (%) | 104 (49) | 100 (49) | 82 (44) | 91 (47) |
Lung function at screening, mean (SD) | ||||
Post-bronchodilator FEV1, mL | 1137 (314) | 1097 (290) | 1775 (437) | 1803 (420) |
Post-bronchodilator percent predicted FEV1, % | 39.2 (7.8) | 38.6 (7.6) | 62.1 (8.2) | 62.4 (7.8) |
Post-bronchodilator FEV1/FVC ratio | 0.437 (0.099) | 0.445 (0.097) | 0.557 (0.081) | 0.561 (0.079) |
Percent reversibility to salbutamol, %a | 10.9 (14.9) | 9.8 (12.1) | 6.3 (11.0) | 7.4 (10.9) |
COPD exacerbations in the previous 12 months, n (%) | ||||
Moderate COPD exacerbations | ||||
0 | 117 (55) | 115 (57) | 27 (15) | 36 (18) |
1 | 39 (18) | 32 (16) | 4 (2) | 8 (4) |
≥2 | 56 (26) | 56 (28) | 154 (83) | 151 (77) |
Severe COPD exacerbations | ||||
0 | 168 (79) | 163 (80) | 148 (80) | 147 (75) |
1 | 41 (19) | 37 (18) | 31 (17) | 40 (21) |
≥2 | 3 (1) | 3 (1) | 6 (3) | 8 (4) |
CAT score at screening, mean (SD)b | 21.6 (5.58) | 21.2 (5.41) | 19.7 (4.68) | 19.8 (4.76) |
SGRQ total score at baseline, mean (SD)c | 53.3 (15.39) | 50.0 (15.62) | 46.4 (15.55) | 45.5 (14.24) |
