Table 3.
Patients’ characteristics in TRILOGY and TRINITY studies – safety population
| TRILOGY24
|
TRINITY25
|
||||
|---|---|---|---|---|---|
| BDP/FF/GB n=687 |
BDP/FF n=680 |
BDP/FF/GB n=1,077 |
Tiotropium n=1,076 |
BDP/FF + tiotropium n=537 |
|
| Mean age in years (SD) | 63.3 (7.9) | 63.8 (8.2) | 63.4 (8.7) | 63.3 (8.4) | 62.6 (8.9) |
| Duration of the disease, years (mean, SD) | 7.7 (5.8) | 7.7 (6.0) | 7.9 (5.6) | 8.2 (6.1) | 7.8 (5.4) |
| No. of exacerbations in previous year (mean, SD) | 1.2 (0.5) | 1.2 (0.5) | 1.3 (0.7) | 1.3 (0.6) | 1.2 (0.6) |
| Time since last exacerbation months (mean, SD) | 6.2 (2.8) | 6.0 (2.9) | 5.9 (2.9) | 6.0 (2.8) | 6.0 (2.9) |
| Current smoker n (% of group) | 323 (47.0) | 318 (46.8) | 517 (48.0) | 503 (46.7) | 266 (49.5) |
| Mean pack-year history (SD) | 39.0 (18.6) | 39.9 (19.6) | 38.1 (18.9) | 38.2 (18.3) | 38.5 (17.3) |
| FEV1, L (mean, SD) | 1.111 (0.319) | 1.104 (0.334) | 1.118 (0.384) | 1.129 (0.358) | 1.137 (0.392) |
| FEV1, % pred (mean, SD) | 36.9 (8.4) | 36.2 (8.6) | 36.6 (8.3) | 36.6 (8.1) | 36.7 (8.3) |
| FEV1 <30% normal n (% of group) | 155 (22.6) | 155 (22.8) | 228 (21.2) | 229 (21.3) | 113 (21.0) |
| Reversibility, L (mean, SD) | 0.089 (0.130) | 0.093 (0.135) | 0.066 (0.136) | 0.061 (0.134) | 0.072 (0.141) |
Abbreviations: BDP, beclomethasone dipropionate; FEV1, forced expiratory volume in the first second; FF, formoterol fumarate; GB, glycopyrronium bromide.