Table 4.
Primary and other ophthalmological endpoints# (ophthalmological population)
| BGF MDI 320/18/9.6 μg (N = 132) | BFF MDI 320/9.6 μg (N = 54) | GFF MDI 18/9.6 μg (N = 125) | |
|---|---|---|---|
| LOCS III P score | |||
| n | 218 | 98 | 184 |
| Baseline (mean [SD]) | 0.381 (0.880) | 0.397 (0.650) | 0.308 (0.567) |
| Change from baseline to Week 52 (primary ophthalmological endpoint) | |||
| LSM | 0.153 | 0.022 | 0.026 |
| 95% CI | (0.079, 0.227) | (−0.090, 0.135) | (−0.055, 0.106) |
| LSM difference between treatments | |||
| Versus GFF MDI 18/9.6 μg¶ | |||
| LSM | 0.127 | −0.003 | NA |
| 95% CI | (0.017, 0.237) | (− 0.142, 0.135) | |
| Versus BFF MDI 320/9.6 μg§ | |||
| LSM | 0.130 | NA | Shown above |
| 95% CI | (−0.004, 0.265) | ||
| LOCS III NO score | |||
| n | 220 | 98 | 187 |
| Baseline (mean [SD]) | 2.447 (1.082) | 2.336 (0.886) | 2.309 (1.060) |
| Change from baseline to Week 52 | |||
| LSM | 0.255 (0.170, 0.340) | 0.186 (0.059, 0.314) | 0.047 (−0.045, 0.138) |
| 95% CI | |||
| LSM difference between treatments§ | |||
| Versus GFF MDI 18/9.6 μg | |||
| LSM | 0.208 | 0.140 | NA |
| 95% CI | (0.084, 0.333) | (−0.017, 0.297) | |
| Versus BFF MDI 320/9.6 μg | |||
| LSM | 0.069 | NA | Shown above |
| 95% CI | (−0.084, 0.222) | ||
| LOCS III NC score | |||
| n | 219 | 98 | 187 |
| Baseline (mean [SD]) | 2.290 (1.137) | 2.287 (0.951) | 2.178 (0.858) |
| Change from baseline to Week 52 | |||
| LSM | 0.130 | 0.142 | 0.163 |
| 95% CI | (0.050, 0.209) | (0.022, 0.263) | (0.077, 0.248) |
| LSM difference between treatments§ | |||
| Versus GFF MDI 18/9.6 μg | |||
| LSM | −0.033 | −0.021 | NA |
| 95% CI | (−0.150, 0.084) | (−0.169, 0.128) | |
| Versus BFF MDI 320/9.6 μg | |||
| LSM | −0.013 | NA | Shown above |
| 95% CI | (−0.157, 0.132) | ||
| LOCS III C score | |||
| n | 218 | 98 | 187 |
| Baseline (mean [SD]) | 0.832 (1.189) | 0.801 (0.976) | 0.727 (1.060) |
| Change from baseline to Week 52 | |||
| LSM | 0.105 (0.022, 0.187) | 0.170 (0.047, 0.294) | 0.067 (−0.022, 0.155) |
| 95% CI | |||
| LSM difference between treatments§ | |||
| Versus GFF MDI 18/9.6 μg | |||
| LSM | 0.038 | 0.103 | NA |
| 95% CI | (−0.083, 0.159) | (−0.049, 0.256) | |
| Versus BFF MDI 320/9.6 μg | |||
| LSM | −0.065 | NA | Shown above |
| 95% CI | (−0.214, 0.083) | ||
| IOP, mmHg | |||
| n | 228 | 100 | 203 |
| Baseline (mean [SD]) | 14.482 (2.908) | 15.490 (2.740) | 14.978 (2.971) |
| Change from baseline to Week 52 | |||
| LSM | 0.670 | 0.178 | 0.680 |
| 95% CI | (0.330, 1.010) | (−0.339, 0.696) | (0.321, 1.039) |
| LSM difference between treatments§ | |||
| Versus GFF MDI 18/9.6 μg | |||
| LSM | −0.010 | −0.502 | NA |
| 95% CI | (−0.505, 0.486) | (−1.131, 0.128) | |
| Versus BFF MDI 320/9.6 μg | |||
| LSM | 0.492 | NA | Shown above |
| 95% CI | (−0.129, 1.113) | ||
BFF Budesonide/formoterol fumarate, BGF Budesonide/glycopyrrolate/formoterol fumarate, C Cortical cataract, CI Confidence interval, GFF Glycopyrrolate/formoterol fumarate, IOP Intraocular pressure, LOCS III Lens opacities classification system III, LSM Least squares mean, MDI Metered dose inhaler, NA Not applicable, NC Nuclear color, NO Nuclear opalescence, P Posterior subcapsular cataract, SD Standard deviation. #: data presented are across eyes (irrespective of person) such that n = total number of eyes assessed, ¶: non-inferiority was declared if the upper confidence bound for the treatment difference was <0.5, §: not a pre-specified non-inferiority comparison