Summary of LS mean changes from baseline for spirometric endpoints, overall and stratified by FEV1 % predicted – ITT population
| Endpoint | FLUT/FORM 500/20 μg n=154 | FLUT + FORM 500 μg + 24 μg n=156 |
|---|---|---|
| Change in pre-dose FEV1 from Day 1 to Day 56 | ||
| All patients | 0.346 | 0.267 |
| Treatment difference (95% CI) | 0.079 (–0.032, 0.190) | |
| P-value | P = 0.164 | |
| FEV1 ≤60% subgroup | 0.414 | 0.353 |
| Treatment difference (95% CI) | 0.061 (–0.108, 0.231) | |
| P-value | P = 0.477 | |
| FEV1 >60% subgroup | 0.260 | 0.173 |
| Treatment difference (95% CI) | 0.087 (–0.053, 0.227) | |
| P-value | P = 0.222 | |
| Change in pre-dose FEV1 from pre-dose Day 1 to 2-hours post-dose Day 56 | ||
| All patients | 0.517 | 0.477 |
| Treatment difference (95% CI) | 0.040 (–0.069, 0.149) | |
| P-value | P = 0.471 | |
| FEV1 ≤60% subgroup | 0.569 | 0.577 |
| Treatment difference (95% CI) | 0.007 (–0.172, 0.157) | |
| P-value | P = 0.930 | |
| FEV1 >60% subgroup | 0.449 | 0.367 |
| Treatment difference (95% CI) | 0.082 (–0.056, 0.221) | |
| P-value | P = 0.244 | |