Table 2.
Primary and other BMD endpoints (BMD population)
| BGF MDI 320/18/9.6 μg (N = 133) |
BFF MDI 320/9.6 μg(N = 60) | GFF MDI 18/9.6 μg (N = 130) | |
|---|---|---|---|
| Lumbar spine BMD (L2-L4) | |||
| n | 128 | 57 | 123 |
| Baseline, g·cm−2 (mean [SD]) | 1.18 (0.21) | 1.19 (0.20) | 1.16 (0.18) |
| Change from baseline at Week 52, % (primary BMD endpoint) | |||
| LSM | −0.09 | −0.12 | 0.38 |
| 95% CI | (−0.74, 0.56) | (− 1.09, 0.86) | (−0.28, 1.04) |
| LSM % difference between treatments | |||
| Versus GFF MDI 18/9.6 μg# | |||
| LSM | −0.47 | −0.50 | NA |
| 95% CI | (−1.38, 0.45) | (− 1.69, 0.68) | |
| Versus BFF MDI 320/9.6 μg¶ | |||
| LSM | 0.03 | NA | Shown above |
| 95% CI | (−1.13, 1.20) | ||
| Total hip BMD | |||
| n | 128 | 57 | 119 |
| Baseline, g·cm−2(mean [SD]) | 0.94 (0.15) | 0.98 (0.16) | 0.93 (0.14) |
| Change from baseline at Week 52, % | |||
| LSM | −0.87 | −1.12 | − 0.32 |
| 95% CI | (−1.39, −0.34) | (−1.90, − 0.33) | (− 0.86, 0.23) |
| LSM % difference between treatments¶ | |||
| Versus GFF MDI 18/9.6 μg | |||
| LSM | −0.55 | −0.81 | NA |
| 95% CI | (−1.30, 0.21) | (−1.79, 0.16) | |
| Versus BFF MDI 320/9.6 μg | |||
| LSM | 0.25 | NA | Shown above |
| 95% CI | (−0.70, 1.21) | ||
BMD Bone mineral density, BFF Budesonide/formoterol fumarate, BGF Budesonide/glycopyrrolate/formoterol fumarate, CI Confidence interval, GFF Glycopyrrolate/formoterol fumarate, L Lumbar spine segment, LSM Least squares mean, MDI Metered dose inhaler, NA Not applicable, SD Standard deviation, # non-inferiority was declared if the lower confidence bound for the percentage treatment difference was >−2%, ¶ not a pre-specified non-inferiority comparison