Table 1.
Baseline hyperinflation parameters and exercise tolerance (combined populations)
| Parameter | UMEC/VI 62.5/25 μg (N=282) | UMEC 62.5 μg (N=89) | VI 25 μg (N=140) | PBO (N=321) |
|---|---|---|---|---|
| Age (years), mean (SD) | 62.0 (7.9) | 61.7 (7.9) | 61.5 (8.2) | 62.0 (8.2) |
| Sex (male), n (%) | 160 (57) | 53 (60) | 80 (57) | 180 (56) |
| Pre-bronchodilator FEV1 (L), n | 281 | 88 | 140 | 321 |
| Mean (SD) | 1.400 (0.450) | 1.397 (0.432) | 1.395 (0.450) | 1.346 (0.433) |
| Post-salbutamol FEV1 (L), n | 282 | 88 | 140 | 319 |
| Mean (SD) | 1.547 (0.424) | 1.572 (0.408) | 1.556 (0.445) | 1.511 (0.411) |
| Post-salbutamol predicted FEV1 (%), n | 282 | 88 | 140 | 319 |
| Mean (SD) | 51.5 (9.7) | 53.2 (9.8) | 51.4 (9.6) | 50.9 (9.8) |
| Pre-bronchodilator FVC (L), n | 281 | 88 | 140 | 321 |
| Mean (SD) | 3.026 (0.871) | 3.032 (0.859) | 2.937 (0.780) | 2.900 (0.846) |
| Post-salbutamol FVC (L), n | 282 | 88 | 140 | 319 |
| Mean (SD) | 3.282 (0.912) | 3.336 (0.857) | 3.193 (0.799) | 3.177 (0.871) |
| IC/TLC (%),a n | 282 | 88 | 140 | 321 |
| Mean (SD) | 31.8 (8.1) | 31.8 (6.1) | 32.6 (7.3) | 31.7 (7.3) |
| ISWT (m), n | 282 | 89 | 140 | 320 |
| Mean (SD) | 403.2 (149.6) | 426.6 (153.3) | 415.9 (145.9) | 418.9 (152.1) |
| EET (seconds), n | 280 | 88 | 137 | 317 |
| Mean (SD) | 307.7 (162.6) | 297.1 (159.4) | 303.5 (130.4) | 328.1 (182.1) |
a
Note: Data from one patient were excluded from the IC/TLC and IC analyses throughout, due to outlying data (baseline IC 0.12 L, range of other subjects 0.67–4.77 L).
Abbreviations: EET, exercise-endurance time; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; IC, inspiratory capacity; ISWT, incremental shuttle-walk test; PBO, placebo; SD, standard deviation; TLC, total lung capacity; UMEC, umeclidinium; VI, vilanterol.