Table 1 Patient demographics and baseline characteristics (ITT population)
AB/FF 400/12 μg (N = 720) | AB 400 μg (N = 720) | FF 12 μg (N = 715) | Placebo (N = 525) | |
|---|---|---|---|---|
Mean age, years | 63.4 | 63.7 | 63.5 | 63.7 |
Male, n (%) | 429 (59.6) | 442 (61.4) | 423 (59.2) | 313 (59.6) |
White, n (%) | 672 (93.3) | 675 (93.8) | 672 (94.0) | 499 (95.0) |
Current smoker, n (%) | 354 (49.2) | 351 (48.8) | 350 (49.0) | 263 (50.1) |
Cigarette smoking, mean pack-years (SD) | 46.6 (25.1) | 44.9 (23.7) | 45.8 (22.4) | 49.2 (26.5) |
Mean FEV1, L (SD) | 1.387 (0.524) | 1.376 (0.519) | 1.397 (0.510) | 1.382 (0.550) |
Post-bronchodilator percent of predicted FEV1, % (SD) | 53.9 (13.2) | 53.3 (13.2) | 54.2 (13.1) | 53.5 (13.4) |
COPD severity | ||||
Moderate, n (%)a | 418 (58.1) | 411 (57.1) | 436 (61.0) | 293 (55.8) |
Severe, n (%)b | 301 (41.8) | 306 (42.5) | 278 (38.9) | 231 (44.0) |
Mean number of exacerbations in previous 12 months (SD) | 0.5 (0.9) | 0.5 (0.8) | 0.4 (0.8) | 0.3 (0.7) |
Mean BDI focal score (SD) | 6.4 (2.1) | 6.5 (2.1) | 6.4 (2.2) | 6.5 (2.2) |
Mean SGRQ total score (SD) | 46.8 (17.4) | 46.1 (17.3) | 45.5 (18.0) | 45.5 (17.8) |
Previous treatment with a LABA and / or LAMA, n (%)c | 355 (49.3) | 371 (51.5) | 362 (50.6) | 254 (48.4) |
Baseline ICS use, n (%) | 259 (36.0) | 255 (35.4) | 244 (34.1) | 183 (34.9) |