Functional respiratory imaging, body plethysmography and spirometry endpoints on Day 15 (end of treatment period)
| Co-primary functional respiratory imaging endpoints | ||||
|---|---|---|---|---|
| GFF MDI 14.4/10 µg | Placebo MDI | LSM ratio GFF vs placebo | p value | |
| siVaw at TLC, mL/L
n patients/n lobes Geometric LSM (95% CI) | 19/92 1.79 (1.48–2.16) | 19/92 1.02 (0.85–1.24) | 1.75 (1.65–1.86) | <0.0001 |
| siRaw at TLC, kPa·s
n patients/n lobes Geometric LSM (95% CI) | 19/92 0.09 (0.07–0.11) | 19/92 0.30 (0.23–0.40) | 0.29 (0.25–0.33) | <0.0001 |
| Spirometry endpoints | ||||
| GFF MDI 14.4/10 µg | Placebo MDI | LSM difference GFF vs placebo | p value | |
| FEV1, mL
n patients LSM change from baseline (95% CI) | 19 334 (245–422) | 19 −110 (−198,–22) | 443 (318–569) | <0.0001 |
| IC, mL
n patients LSM change from baseline (95% CI) | 19 318 (144–491) | 19 −136 (−310, 37) | 454 (209–699) | 0.0006 |
| Body plethysmography endpoints | ||||
| GFF MDI 14.4/10 µg | Placebo MDI | LSM ratio GFF vs placebo | p value | |
| FRC, mL
n patients LSM ratio to baseline (95% CI) | 19 0.90 (0.86–0.93) | 19 1.03 (0.99–1.07) | 0.87 (0.82–0.92) | <0.0001 |
| RV, mL
n patients LSM ratio to baseline (95% CI) | 19 0.83 (0.79–0.88) | 19 1.07 (1.01–1.13) | 0.78 (0.72–0.84) | <0.0001 |
CI, confidence interval; FEV1, forced expiratory volume in 1 s; FRC, functional residual capacity; GFF, glycopyrronium/formoterol fumarate dihydrate; IC, inspiratory capacity; LSM, least squares mean; MDI, metered dose inhaler; RV, residual volume; siRaw, specific image-based airway resistance; siVaw, specific image-based airway volume; TLC, total lung capacity.