Table 3.
Other efficacy endpoints
| FF/VI | TIO | LS mean change difference (95% CI) | |
|---|---|---|---|
| Trough (predose) FEV1 (L), n | 268 | 249 | |
| Baseline mean (SD) | 1.35 (0.47) | 1.35 (0.50) | |
| Day 84 mean (SD) | 1.43 (0.50) | 1.43 (0.51) | |
| LS mean change from baseline (SE) | 0.098 (0.013) | 0.093 (0.014) | 0.005 (−0.029 to 0.039) |
| Trough (predose) IC (L), n | 267 | 253 | |
| Baseline mean (SD) | 2.06 (0.60) | 2.09 (0.62) | |
| Day 84 mean (SD) | 2.13 (0.62) | 2.20 (0.65) | |
| LS mean change from baseline (SE) | 0.075 (0.022) | 0.134 (0.023) | −0.059 (−0.115 to −0.002) |
| Trough (predose) FVC (L), n | 268 | 249 | |
| Baseline mean (SD) | 2.67 (0.78) | 2.68 (0.84) | |
| Day 84 mean (SD) | 2.72 (0.82) | 2.80 (0.84) | |
| LS mean change from baseline (SE) | 0.050 (0.022) | 0.133 (0.023) | −0.083 (−0.138 to −0.028) |
| Dyspnea symptom score,a n | 301 | 298 | |
| Baseline mean (SD) | 1.84 (0.86) | 1.84 (0.84) | |
| Weeks 1–12 mean (SD) | 1.53 (0.76) | 1.62 (0.74) | |
| LS mean change from baseline (SE) | −0.35 (0.04) | −0.26 (0.04) | −0.09 (−0.18 to −0.00) |
| Cough symptom score,b n | 299 | 296 | |
| Baseline mean (SD) | 1.50 (0.76) | 1.56 (0.72) | |
| Weeks 1–12 mean (SD) | 1.39 (0.68) | 1.44 (0.65) | |
| LS mean change from baseline (SE) | −0.17 (0.03) | −0.15 (0.03) | −0.02 (−0.09 to 0.06) |
| Sputum production symptom score,b n | 297 | 296 | |
| Baseline mean (SD) | 1.32 (0.82) | 1.35 (0.83) | |
| Weeks 1–12 mean (SD) | 1.25 (0.72) | 1.26 (0.71) | |
| LS mean change from baseline (SE) | −0.08 (0.03) | −0.10 (0.03) | 0.01 (−0.06 to 0.09) |
| Percent symptom-free periods,c n | 297 | 296 | |
| Baseline mean (SD) | 2.3 (12.7) | 3.0 (14.1) | |
| Weeks 1–12 mean (SD) | 5.0 (15.3) | 3.8 (13.0) | |
| LS mean change from baseline (SE) | 2.9 (0.8) | 1.4 (0.8) | 1.5 (−0.4 to 3.4) |
Notes:
a
Scored from 0 (not breathless at rest or upon exertion) to 4 (breathless at rest);
b
scored from 0 (none) to 3 (severe);
c
24-h period.
Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 second; FF/VI, fluticasone furoate/vilanterol (100/25 mcg); FVC, forced vital capacity; h, hours; IC, inspiratory capacity; LS, least squares; SD, standard deviation; SE, standard error; TIO, tiotropium (18 mcg).