Table 2.
Lung Function Endpoints for the Pooled PINNACLE-1, -2, and -4 Studies in GOLD 2017 Category A Patients (ITT Population)
| GFF MDI 18/9.6 µg | GP MDI 18 µg | FF MDI 9.6 µg | Placebo MDI | |
|---|---|---|---|---|
| Baseline FEV1, L | ||||
| n | 216 | 195 | 204 | 113 |
| Mean (SD) | 1.393 (0.466) | 1.345 (0.507) | 1.323 (0.483) | 1.329 (0.491) |
| Change from baseline in morning pre-dose trough FEV1, mL | ||||
| At Week 24 | ||||
| n | 197 | 177 | 178 | 96 |
| LSM (SE) | 106 (13.4) | 52 (14.2) | 44 (14.1) | –82 (19.0) |
| Treatment difference for GFF MDI vs monocomponents and placebo MDI | ||||
| LSM (95% CI) | NA | 54 (16, 92)* | 62 (25, 100)* | 188 (143, 234)** |
| Over 24 weeks | ||||
| n | 214 | 191 | 199 | 107 |
| LSM (SE) | 134 (10.1) | 72 (10.7) | 75 (10.6) | –49 (14.2) |
| Treatment difference for GFF MDI vs monocomponents and placebo MDI | ||||
| LSM (95% CI) | NA | 62 (33, 90)** | 59 (31, 87)** | 183 (149, 217)** |
| Peak change from baseline in FEV1 within 2 hrs post-dose, mL | ||||
| At Week 24 | ||||
| n | 198 | 177 | 179 | 96 |
| LSM (SE) | 335 (15.0) | 210 (15.8) | 230 (15.7) | 28 (21.1) |
| Treatment difference for GFF MDI vs monocomponents and placebo MDI | ||||
| LSM (95% CI) | NA | 124 (82, 167)** | 104 (62, 147)** | 307 (256, 358)** |
| Over 24 weeks | ||||
| n | 216 | 195 | 204 | 113 |
| LSM (SE) | 357 (10.9) | 221 (11.4) | 275 (11.3) | 57 (15.1) |
| Treatment difference for GFF MDI vs monocomponents and placebo MDI | ||||
| LSM (95% CI) | NA | 136 (106, 167)** | 83 (52, 113)** | 300 (264, 336)** |
Notes: *p<0.01; **p<0.0001.
Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 second; FF, formoterol fumarate; GFF, glycopyrrolate/formoterol fumarate; GOLD, Global Initiative for Chronic Obstructive Lung Disease; GP, glycopyrrolate; ITT, intent-to-treat; LSM, least squares mean; NA, not applicable; MDI, metered dose inhaler; SD, standard deviation; SE, standard error.