Table 2.
Primary And Secondary Lung Function Endpoints (China ITT Population)
| GFF MDI 18/9.6 µg | GP MDI 18 µg | FF MDI 9.6 µg | Placebo MDI | |
|---|---|---|---|---|
| Primary endpoint | ||||
| Change from baseline in morning pre-dose trough FEV1 at Week 24, mL | ||||
| n | 126 | 110 | 116 | 54 |
| LSM (SE) | 133 (17.3) | 35 (18.7) | 29 (18.1) | −39 (−26.6) |
| Treatment difference for GFF MDI vs monocomponents and placebo MDI | ||||
| LSM (95% CI) | NA | 98 (48, 148) | 104 (55, 153) | 173 (110, 235) |
| P-value | NA | 0.0001 | <0.0001 | <0.0001 |
| Secondary endpoints | ||||
| Change from baseline in morning pre-dose trough FEV1 over 24 weeksa, mL | ||||
| n | 143 | 121 | 131 | 60 |
| LSM (SE) | 143 (13.3) | 64 (14.5) | 50 (13.9) | −20 (20.6) |
| Treatment difference for GFF MDI vs monocomponents and placebo MDI | ||||
| LSM (95% CI) | NA | 79 (40, 118) | 93 (55, 131) | 163 (115, 212) |
| P-value | NA | <0.0001 | <0.0001 | <0.0001 |
| Peak change from baseline in FEV1 within 2 hrs post-dosing at Week 24, mL | ||||
| n | 128 | 110 | 116 | 54 |
| LSM (SE) | 377 (19.7) | 195 (21.3) | 226 (20.7) | 72 (30.3) |
| Treatment difference for GFF MDI vs monocomponents and placebo MDI | ||||
| LSM (95% CI) | NA | 182 (125, 239) | 151 (95, 207) | 305 (234, 376) |
| P-value | NA | <0.0001 | <0.0001 | <0.0001 |
| Onset of action on Day 1 (change from baseline in FEV1), mL | ||||
| Difference vs placebo MDI at 5 mins post-dose | ||||
| n | 119 | 104 | 118 | 52 |
| LSM (95% CI) | 184 (150, 219) | 34 (−1, 70) | 169 (135, 204) | NA |
| P-value | <0.0001 | 0.0557 | <0.0001 | NA |
| Difference vs placebo MDI at 15 mins post-dose | ||||
| n | 143 | 117 | 132 | 62 |
| LSM (95% CI) | 225 (189, 262) | 76 (38, 113) | 193 (156, 230) | NA |
| P-value | <0.0001 | <0.0001 | <0.0001 | NA |
Note: aMorning pre-dose trough FEV1 over 24 weeks was based on assessments at Weeks 2, 4, 8, 12, 16, 20, and 24. All p-values <0.05 should only be interpreted in terms of nominal significance as the analyses in the Chinese subgroup were considered exploratory.
Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 second; FF, formoterol fumarate; GFF, glycopyrrolate/formoterol fumarate; GP, glycopyrrolate; ITT, intent-to-treat; LSM, least squares mean; MDI, metered dose inhaler; NA, not applicable; SE, standard error.