Table S1.
Baseline demographics and clinical characteristics (sub-study ITT population)
| AB/FF 400/12 µg n=120 | AB 400 µg n=161 | FF 12 µg n=110 | TIO 18 µg n=172 | Total N=563 | |
|---|---|---|---|---|---|
| Mean age, years (SD) | 64.4 (8.5) | 64.3 (8.1) | 62.8 (8.7) | 62.4 (8.3) | 63.4 (8.4) |
| Male, n (%) | 72 (60.0) | 108 (67.1) | 66 (60.0) | 103 (59.9) | 349 (62.0) |
| Caucasian, n (%) | 113 (94.2) | 150 (93.2) | 105 (95.5) | 162 (94.2) | 530 (94.1) |
| Current smoker, n (%) | 71 (59.2) | 93 (57.8) | 63 (57.3) | 109 (63.4) | 336 (59.7) |
| Smoking history, mean pack-years (SD) | 48.3 (22.8) | 47.0 (22.6) | 48.0 (28.0) | 46.4 (21.0) | 47.3 (23.3) |
| Concomitant ICS use, n (%) | 39 (32.5) | 44 (27.3) | 32 (29.1) | 51 (29.7) | 166 (29.5) |
| COPD severity, n (%) Moderate Severe Very severe |
70 (58.3) 38 (31.7) 12 (10.0) |
75 (46.6) 67 (41.6) 19 (11.8) |
53 (48.2) 44 (40.0) 13 (11.8) |
101 (58.7) 60 (34.9) 11 (6.4) |
299 (53.1) 209 (37.1) 55 (9.8) |
| Mean post-bronchodilator FEV1 % predicted, mean (SD) | 52.4 (15.5) | 48.4 (14.7) | 50.4 (15.2) | 51.8 (13.5) | 50.7 (14.6) |
| Bronchial reversibility, % (SD) | 14.8 (11.8) | 18.3 (14.5) | 17.2 (15.4) | 16.2 (14.1) | 16.7 (14.1) |
| FEV1, L, mean (SD) | 1.325 (0.547) | 1.248 (0.497) | 1.318 (0.503) | 1.348 (0.519) | 1.309 (0.516) |
| Mean exacerbations in previous 12 months (SD) | 0.3 (0.6) | 0.3 (0.6) | 0.3 (0.5) | 0.2 (0.5) | 0.3 (0.5) |
| Mean SGRQ total score (SD) | 49.1 (16.9) | 52.0 (16.2) | 51.8 (17.0) | 51.3 (16.5) | 51.1 (16.6) |
| Mean CAT score (SD) | 21.1 (5.9) | 21.7 (6.3) | 21.3 (6.3) | 21.5 (6.1) | 21.4 (6.1) |
| Mean NiSCI score (SD) | 1.02 (0.69) | 1.09 (0.73) | 1.01 (0.72) | 1.08 (0.76) | 1.05 (0.73) |
| Mean EMSCI score (SD) | 1.29 (0.65) | 1.35 (0.60) | 1.32 (0.65) | 1.33 (0.67) | 1.32 (0.64) |
| Mean E-RS score (SD) | 12.39 (6.06) | 13.18 (6.10) | 12.52 (6.01) | 12.80 (6.03) | 12.76 (6.05) |
Abbreviations: AB, aclidinium bromide; CAT, COPD Assessment Test; EMSCI, Early Morning Symptoms of COPD Instrument; E-RS, Evaluating-Respiratory Symptoms; FF, formoterol fumarate; ICS, inhaled corticosteroid; ITT, intent-to-treat; NiSCI, Nighttime Symptoms of COPD Instrument; SGRQ, St George’s Respiratory Questionnaire; TIO, tiotropium.