Table 2 Secondary endpoints: lung-function measurements (mITT population)
PT003011 | PT003012 | ||||
|---|---|---|---|---|---|
GFF MDI 18/9.6 μg | Placebo MDI | TIO SMI 5 μg | GFF MDI 18/9.6 μg | Placebo MDI | |
n = 65 | n = 65 | n = 67 | n = 35 | n = 31 | |
FEV1 AUC12–24 (mL) on day 29, LSM (SE) | 159 (27.7) | −118 (27.7) | 39 (27.5) | 115 (29.9) | −127 (32.0) |
Treatment difference GFF MDI vs comparator LSM (95% CI) | NA | 277 (232–321) | 120 (76–164) | NA | 242 (165–319) |
n = 67 | n = 66 | n = 68 | n = 35 | n = 31 | |
FEV1 AUC0–12 (mL) on day 29, LSM (SE) | 226 (25.7) | −26 (25.8) | 178 (25.6) | 216 (29.8) | −39 (31.8) |
Treatment difference GFF MDI vs comparator LSM (95% CI) | NA | 251 (207–296) | 48 (4–92) | NA | 255 (182–329) |
n = 65 | n = 65 | n = 67 | n = 35 | n = 31 | |
Peak change from baseline in FEV1 (mL) following evening dose on day 29, LSM (SE) | 395 (30.9) | 58 (31) | 230 (30.7) | 344 (34.2) | 50 (36.6) |
Treatment difference GFF MDI vs comparator LSM (95% CI) | NA | 337 (282–392) | 165 (110–219) | NA | 293 (204–382) |
n = 67 | n = 67 | n = 68 | n = 35 | n = 31 | |
Peak change from baseline in FEV1 (mL) following morning dose on day 29, LSM (SE) | 406 (28.3) | 129 (28.3) | 325 (28.1) | 410 (35.8) | 134 (37.6) |
Treatment difference GFF MDI vs comparator LSM (95% CI) | NA | 278 (225–330) | 81 (29–133) | NA | 276 (206–347) |
n = 67 | n = 66 | n = 68 | n = 35 | n = 32 | |
Change from baseline in morning pre-dose trough FEV1 on day 29 (mL), LSM (SE) | 140 (22.7) | −20 (22.9) | 97 (22.5) | 130 (21.7) | −12 (22.7) |
Treatment difference GFF MDI vs comparator LSM (95% CI) | NA | 161 (106–215) | 43 (−11–97) | NA | 142 (90–194) |
n = 66 | n = 66 | n = 66 | n = 35 | n = 31 | |
Change from baseline in morning pre-dose trough FEV1 on day 30 (mL), LSM (SE) | 129 (28.4) | −73 (28.4) | 72 (28.3) | 90 (28.8) | −64 (30.2) |
Treatment difference GFF MDI vs comparator LSM (95% CI) | NA | 203 (153–252) | 58 (8–108) | NA | 154 (97–211) |