Table 1 Demographic and baseline characteristics a
Characteristics, mean (SD)b | PBO (n = 332) | ACL400/FOR12 FDC (n = 335) | ACL400/FOR6 FDC (n = 333) | ACL 400 (n = 337) | FOR 12 (n = 332) |
|---|---|---|---|---|---|
Age, years | 63.5 (8.9) | 64.2 (8.9) | 63.9 (9.2) | 64.4 (8.7) | 63.7 (8.7) |
Male, n (%) | 175 (52.7) | 168 (50.1) | 187 (56.2) | 188 (55.8) | 169 (50.9) |
White, n (%) | 317 (95.5) | 305 (91.0) | 309 (92.8) | 314 (93.2) | 311 (93.7) |
Current smoker, n (%) | 169 (50.9) | 173 (51.6) | 176 (52.9) | 171 (50.7) | 171 (51.5) |
Smoking history, pack-years | 53.3 (28.5) | 53.3 (27.2) | 52.1 (25.8) | 52.0 (26.1) | 52.5 (23.7) |
Prebronchodilator FEV1, L | 1.35 (0.54) | 1.34 (0.53) | 1.40 (0.54) | 1.34 (0.53) | 1.37 (0.52) |
Postbronchodilator FEV1, % of predicted | 52.6 (13.3) | 53.2 (13.4) | 54.7 (12.9) | 53.0 (13.3) | 53.9 (13.1) |
Bronchial reversibility, % | 18.4 (15.2) | 17.2 (14.6) | 17.7 (15.0) | 19.1 (16.5) | 17.3 (14.7) |
COPD severity, n (%)c | Â | Â | Â | Â | Â |
Moderate | 177 (53.3) | 189 (56.4) | 203 (61.0) | 184 (54.6) | 197 (59.3) |
Severe | 150 (45.2) | 142 (42.4) | 127 (38.1) | 147 (43.6) | 131 (39.5) |
Baseline efficacy variablesd | Â | Â | Â | Â | Â |
SGRQ total score | 45.3 (17.9) | 47.6 (16.9) | 46.2 (17.9) | 45.2 (17.8) | 45.8 (17.9) |
BDI focal score | 6.4 (2.4) | 6.2 (2.1) | 6.5 (2.2) | 6.5 (2.3) | 6.3 (2.3) |
Rescue medication use, puffs/day | 4.2 (3.9) | 4.5 (3.7) | 4.0 (3.3) | 4.0 (3.4) | 4.3 (3.7) |
EXACT-RS score | 11.03 (5.84) | 11.89 (6.51) | 11.46 (6.25) | 11.27 (6.33) | 11.40 (6.57) |
NiSCI score | 0.95 (0.63) | 1.10 (0.70) | 0.99 (0.69) | 1.00 (0.70) | 0.99 (0.71) |
EMSCI score | 1.07 (0.58) | 1.19 (0.63) | 1.15 (0.64) | 1.13 (0.65) | 1.13 (0.66) |