Table 1.
Baseline demographics and clinical characteristics (safety population)
| BGF MDI 320/18/9.6 μg (N = 194) |
BFF MDI 320/9.6 μg (N = 88) |
GFF MDI 18/9.6 μg (N = 174) |
|
|---|---|---|---|
| Age, years (mean [SD]) | 62.6 (7.9) | 64.0 (7.2) | 62.4 (7.8) |
| Male, n (%) | 102 (52.6) | 53 (60.2) | 87 (50.0) |
| Race, n (%) | |||
| White | 179 (92.3) | 79 (89.8) | 156 (89.7) |
| Black | 13 (6.7) | 9 (10.2) | 17 (9.8) |
| Other | 2 (1.0) | 0 | 1 (0.6) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 9 (4.6) | 6 (6.8) | 5 (2.9) |
| Not Hispanic or Latino | 185 (95.4) | 82 (93.2) | 169 (97.1) |
| Body mass index, kg·m−2 (mean [SD]) | 29.0 (7.4) | 29.0 (5.8) | 29.0 (6.5) |
| Current smoker, n (%) | 101 (52.1) | 42 (47.7) | 95 (54.6) |
| Number of pack-years smoked# (median [range]) | 45.0 (11.2–256.0) | 47.3 (14.3–134.0) | 50.0 (10.0–171.0) |
| COPD severity, n (%) | |||
| Moderate | 95 (49.0) | 45 (51.1) | 91 (52.3) |
| Severe | 86 (44.3) | 37 (42.0) | 65 (37.4) |
| Very severe | 13 (6.7) | 6 (6.8) | 18 (10.3) |
| COPD duration, years (mean [SD]) | 8.6 (6.7) | 9.6 (6.3) | 7.7 (5.3) |
| Moderate/severe COPD exacerbations in the past 12 months, n (%) | |||
| 0 | 152 (78.4) | 67 (76.1) | 129 (74.1) |
| 1 | 33 (17.0) | 18 (20.5) | 34 (19.5) |
| ≥2 | 9 (4.6) | 3 (3.4) | 11 (6.3) |
| Eosinophil count, cells·mm− 3 (median, [range]) | 180 (10–655) | 190 (15–505) | 185 (40–2490) |
| <150 cells·mm− 3, n (%) | 68 (35.1) | 32 (36.4) | 54 (31.0) |
| ≥150 cells·mm−3, n (%) | 126 (64.9) | 56 (63.6) | 120 (69.0) |
| Use of ICS at screening, n (%) | 152 (78.4) | 73 (83.0) | 127 (73.0) |
| CAT total score (mean [SD]) | 21.2 (6.4)n = 192 | 22.3 (6.7) n = 86 | 20.4 (6.3) n = 172 |
| EXACT total score (mean [SD])¶ | 35.2 (10.8)n = 194 | 35.7 (10.4) n = 86 | 34.6 (10.6) n = 174 |
| Rescue medication use, puffs·day− 1 (median [range])¶ | 1.9 (0.0–12.0)n = 194 | 2.4 (0.0–17.7) n = 86 | 2.0 (0.0–18.2) n = 174 |
BFF Budesonide/formoterol fumarate, BGF Budesonide/glycopyrrolate/formoterol fumarate, CAT COPD Assessment Test, COPD Chronic obstructive pulmonary disease, EXACT Exacerbations of Chronic Pulmonary Disease Tool, GFF Glycopyrrolate/formoterol fumarate, ICS Inhaled corticosteroid, MDI Metered dose inhaler, mITT Modified intent-to-treat, SD Standard deviation. #: number of pack-years smoked = (number of cigarettes each day/20) × number of years smoked, ¶: mITT population