Table 1.
Patient Demographics and Characteristics by Reported History of Exacerbations
| BGF MDI 320/18/9.6 µg | GFF MDI 18/9.6 µg | BFF MDI 320/9.6 µg | BUD/FORM DPI 400/12 µg | |||||
|---|---|---|---|---|---|---|---|---|
| Patient exacerbation history | No prior (n=469) | Prior (n=170) | No prior (n=473) | Prior (n=152) | No prior (n=235) | Prior (n=79) | No prior (n=234) | Prior (n=84) |
| Mean age, years (range) | 65.4 (42−80) | 63.5 (40–80) | 65.3 (42–80) | 64.6 (46–80) | 65.8 (48–80) | 63.5 (46–78) | 66.1 (45–80) | 65.4 (46–79) |
| Male, % | 73 | 70 | 70 | 64 | 75 | 59 | 75 | 71 |
| Race, % | ||||||||
| Asian | 42 | 52 | 44 | 49 | 45 | 47 | 44 | 46 |
| Black | 4 | 3 | 7 | 4 | 4 | 8 | 5 | 2 |
| White | 54 | 45 | 49 | 47 | 51 | 46 | 51 | 51 |
| Current smokers, % | 41 | 36 | 42 | 38 | 37 | 35 | 40 | 35 |
| ICS use at screening, % | 71 | 76 | 70 | 76 | 69 | 78 | 67 | 81 |
| Blood eosinophil count | ||||||||
| <150 cells per mm3, % | 48 | 53 | 47 | 44 | 44 | 61 | 50 | 46 |
| ≥150 cells per mm3, % | 52 | 47 | 53 | 56 | 56 | 39 | 50 | 54 |
| Post-bronchodilator FEV1, mean % predicted | 51 | 49 | 51 | 49 | 51 | 48 | 51 | 50 |
Notes: The following races, n (%), were recorded in the no-exacerbation subgroup only: Native Hawaiian or Other Pacific Islander, 1 (0.2) in the GFF MDI 18/9.6 µg treatment group; American Indian or Alaska Native, 1 (0.2) in the BGF MDI 320/18/9.6 µg treatment group.
Abbreviations: BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; BUD/FORM DPI, budesonide/formoterol fumarate dry powder inhaler; FEV1, forced expiratory volume in 1 s; GFF, glycopyrrolate/formoterol fumarate; ICS, inhaled corticosteroids; MDI, metered dose inhaler.