Table 3.
Analysis of TDI focal scores and proportion of TDI responders in the ITT and EXT populations
| TDI focal score | ITT population (24 weeks) | EXT population (52 weeks) | ||
|---|---|---|---|---|
| FF/UMEC/VI 100/62.5/25 µg (n = 911) |
BUD/FOR 400/12 µg (n = 899) |
FF/UMEC/VI 100/62.5/25 µg (n = 210) |
BUD/FOR 400/12 µg (n = 220) |
|
| Baseline dyspnea index, mean (SD) | 5.7 (1.77) | 5.5 (1.83) | 5.9 (1.58) | 5.5 (1.70) |
| Week 4 | ||||
| LS mean (95% CI) | 1.78 (1.61–1.96) | 1.29 (1.11–1.47) | 1.66 (1.28–2.04) | 0.96 (0.58–1.33) |
|
Difference (95% CI) P value |
0.49 (0.24–0.75) < 0.001 |
0.71 (0.17–1.24) 0.010 |
||
| % Responders | 58 | 49 | 55 | 46 |
|
OR (95% CI) P value |
1.52 (1.25–1.86) < 0.001 |
1.51 (1.01–2.26) 0.047 |
||
| Week 24 | ||||
| LS mean (95% CI) | 2.29 (2.10–2.48) | 1.72 (1.52–1.91) | 1.97 (1.56–2.37) | 1.70 (1.29–2.11) |
|
Difference (95% CI) P value |
0.57 (0.30–0.84) < 0.001 |
0.26 (− 0.32 to 0.84) 0.373 |
||
| % Responders | 61 | 51 | 60 | 52 |
|
OR (95% CI) P value |
1.61 (1.33–1.95) < 0.001 |
1.41 (0.95–2.09) 0.089 |
||
| Week 52 | ||||
| LS mean (95% CI) | 1.74 (1.30–2.17) | 1.39 (0.95–1.84) | ||
|
Difference (95% CI) P value |
0.34 (− 0.28 to 0.97) 0.279 |
|||
| % Responders | 53 | 46 | ||
|
OR (95% CI) P value |
1.35 (0.91–1.99) 0.132 |
|||
TDI focal score range is – 9 to 9 (lower scores indicate more deterioration in severity of dyspnea). Response defined as a score of ≥ 1
BUD/FOR budesonide/formoterol, CI confidence interval, EXT extension, FF/UMEC/VI fluticasone furoate/umeclidinium/vilanterol, ITT intent-to-treat, LS least squares, OR ratio of odds of response versus non-response, SD standard deviation, TDI Transition Dyspnea Index