Table 4.
CIDa and COPD Exacerbations (Efficacy Estimand; Japanese mITT Population)
| BGF MDI 320/18/9.6 µg N=139 | GFF MDI 18/9.6 µg N=138 | BFF MDI 320/9.6 µg N=70 | BUD/FORM DPI 400/12 µg N=69 | |
|---|---|---|---|---|
| Time to CIDa | ||||
| Patients with CID, n (%) | 91 (65.5) | 92 (66.7) | 48 (68.6) | 51 (73.9) |
| Treatment difference for BGF MDI vs. comparators | ||||
| Hazard ratio (95% CI) P-value |
NA | 0.93 (0.70, 1.25) 0.6461 |
0.89 (0.63, 1.27) 0.5348 |
0.81 (0.57, 1.14) 0.2270 |
| Rate of moderate or severe COPD exacerbations, model-estimated rate per year | ||||
| Patients with exacerbations, n (%) Rate |
20 (14.4) 0.32 |
28 (20.3) 0.82 |
7 (10.0) 0.23 |
9 (13.0) 0.28 |
| Treatment difference for BGF MDI vs. comparators | ||||
| Rate ratio (95% CI) P-value |
NA | 0.40 (0.19, 0.83) 0.0142 |
1.39 (0.47, 4.13) 0.5556 |
1.16 (0.43, 3.16) 0.7644 |
Notes: aCID was defined as a ≥100 mL decrease from baseline in trough FEV1; a ≥4 point increase from baseline in SGRQ total score; a TDI focal score of –1 point or less; or a treatment-emergent moderate or severe COPD exacerbation occurring up to Week 24.
Abbreviations: BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; BUD/FORM DPI, budesonide/formoterol fumarate dry powder inhaler; CI, confidence interval; CID, clinically important deterioration; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; GFF, glycopyrrolate/formoterol fumarate; MDI, metered dose inhaler; mITT, modified intent-to-treat; NA, not applicable; SGRQ, St George’s Respiratory Questionnaire; TDI, Transition Dyspnea Index.