Table 1 Demographic and baseline disease characteristics (mITT population)
BGF 320/14.4/10 µg | GFF 14.4/10 µg | BFF 320/10 µg | BUD/FORM 400/12 µg | |||||
|---|---|---|---|---|---|---|---|---|
Non-reversible and EOS < 300b (n = 319) | Overall population (n = 639) | Non-reversible and EOS < 300b (n = 315) | Overall population (n = 625) | Non-reversible and EOS < 300b (n = 161) | Overall population (n = 314) | Non-reversible and EOS < 300b (n = 153) | Overall population (n = 318) | |
Mean age, years (SD) | 65.6 (7.5) | 64.9 (7.8) | 65.6 (7.6) | 65.1 (7.7) | 65.3 (7.2) | 65.2 (7.2) | 66.5 (7.5) | 65.9 (7.7) |
Male, n (%) | 216 (67.7) | 460 (72.0) | 207 (65.7) | 430 (68.8) | 108 (67.1) | 224 (71.3) | 104 (68.0) | 236 (74.2) |
Mean CAT Score (SD) | 18.4 (6.7) | 18.7 (6.4) | 18.2 (6.4) | 18.1 (6.1) | 18.5 (6.7) | 18.4 (6.6) | 17.6 (7.0) | 18.0 (6.4) |
Mean body mass index, kg/m2 (SD) | 25.9 (6.9) | 26.1 (6.7) | 25.9 (6.5) | 26.3 (6.4) | 25.4 (5.4) | 26.1 (5.8) | 25.8 (6.0) | 26.2 (6.3) |
Current smoker, n (%) | 123 (38.6) | 256 (40.1) | 132 (41.9) | 257 (41.1) | 61 (37.9) | 115 (36.6) | 64 (41.8) | 122 (38.4) |
Median number of pack-years smokeda (range) | 45.0 (10–192.5) | 45.0 (10.0–256.0) | 45.0 (10.0–171.0) | 45.0 (10.0–171.0) | 47.0 (10.0–192.0) | 45.0 (10.0–192.0) | 45.8 (10.0–153.0) | 45.0 (10.0–180.0) |
Median EOS, cells/mm3 (range) | 130.0 (10.0–295.0) | 150.0 (10.0–2815.0) | 140.0 (15.0–295.0) | 155.0 (15.0–2490.0) | 125.0 (20.0–295.0) | 152.5 (15.0–920.0) | 140.0 (35.0–295.0) | 150.0 (35.0–1100.0) |
Exacerbation history, n (%) | ||||||||
0 | 239 (74.9) | 469 (73.4) | 229 (72.7) | 473 (75.7) | 115 (71.4) | 235 (74.8) | 111 (72.5) | 234 (73.6) |
1 | 61 (19.1) | 125 (19.6) | 63 (20.0) | 108 (17.3) | 37 (23.0) | 61 (19.4) | 29 (19.0) | 59 (18.6) |
≥ 2 | 19 (6.0) | 45 (7.0) | 23 (7.3) | 44 (7.0) | 9 (5.6) | 18 (5.7) | 13 (8.5) | 25 (7.9) |
Post-bronchodilator FEV1% predicted (SD) | 48.5 (15.1) | 50.2 (14.3) | 47.6 (14.3) | 50.2 (13.8) | 47.5 (14.4) | 50.0 (14.0) | 48.5 (14.0) | 50.7 (13.8) |
Mean reversibility, % (SD) | 10.1 (8.7) | 18.8 (14.4) | 9.3 (9.0) | 18.1 (14.3) | 10.3 (9.4) | 19.0 (16.5) | 10.6 (8.2) | 19.9 (15.1) |
Use of ICS at screening, n (%) | 220 (69.0) | 464 (72.6) | 226 (71.7) | 447 (71.5) | 117 (72.7) | 225 (71.7) | 107 (69.9) | 225 (70.8) |