Table 1.
Demographic and Baseline Disease Characteristics (Japanese Safety 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 | |
|---|---|---|---|---|
| Mean age, years (SD) | 69.4 (7.1) | 69.0 (6.1) | 69.7 (6.1) | 70.1 (6.8) |
| Male, n (%) | 130 (93.5) | 126 (91.3) | 68 (97.1) | 68 (98.6) |
| Mean body mass index, kg/m2 (SD) | 22.7 (3.5) | 22.5 (3.3) | 23.1 (3.6) | 23.0 (2.9) |
| Current smoker, n (%) | 40 (28.8) | 41 (29.7) | 19 (27.1) | 21 (30.4) |
| Median number of pack-years smokeda (range) | 51.0 (10.0–186.1) | 52.0 (10.0–135.0) | 50.0 (11.5–192.0) | 55.0 (12.5–180.0) |
| COPD severity, n (%) | ||||
| Moderate | 72 (51.8) | 74 (53.6) | 38 (54.3) | 37 (53.6) |
| Severe | 54 (38.8) | 60 (43.5) | 29 (41.4) | 28 (40.6) |
| Very severe | 13 (9.4) | 4 (2.9) | 3 (4.3) | 4 (5.8) |
| Mean COPD duration, years (SD) | 5.4 (3.9) | 5.2 (4.4) | 5.6 (5.0) | 5.2 (3.7) |
| Moderate or severe COPD exacerbations in the past 12 months, n (%) | ||||
| 0 | 103 (74.1) | 114 (82.6) | 58 (82.9) | 58 (84.1) |
| 1 | 25 (18.0) | 16 (11.6) | 10 (14.3) | 6 (8.7) |
| ≥2 | 11 (7.9) | 8 (5.8) | 2 (2.9) | 5 (7.2) |
| Moderate/severe exacerbation rate | ||||
| Mean (SD) | 0.4 (0.8) | 0.2 (0.6) | 0.2 (0.5) | 0.2 (0.6) |
| Median (range) | 0 (0–5) | 0 (0–4) | 0 (0–3) | 0 (0–2) |
| Eosinophils | ||||
| Median cells/mm3 (range) | 150.0 (30–670) | 162.5 (25–2465) | 140.0 (30–920) | 165.0 (40–1040) |
| ≥150 cells/mm3, n (%) | 70 (50.4) | 75 (54.3) | 34 (48.6) | 39 (56.5) |
| ≥300 cells/mm3, n (%) | 18 (13.0) | 22 (15.9) | 8 (11.4) | 7 (10.1) |
| Mean post-albuterol FEV1, % predicted (SD) | 51.1 (14.4) | 52.2 (13.1) | 52.2 (14.8) | 52.7 (14.5) |
| Reversibility to albuterol | ||||
| Mean post-albuterol FEV1 – pre-albuterol FEV1, mL (SD) | 179.9 (117.0) | 174.1 (120.3) | 170.5 (147.9) | 162.1 (119.4) |
| Reversibleb, n (%) | 55 (39.6) | 51 (37.0) | 24 (34.3) | 26 (37.7) |
| Use of ICS at screening, n (%) | 42 (30.2) | 46 (33.3) | 21 (30.0) | 22 (31.9) |
| BDI focal score | ||||
| N | 133 | 126 | 64 | 64 |
| Mean (SD) | 7.5 (1.8) | 7.5 (1.8) | 7.7 (2.1) | 7.6 (1.8) |
| SGRQ total score | ||||
| N | 133 | 126 | 65 | 64 |
| Mean (SD) | 35.6 (14.4) | 37.0 (13.8) | 32.7 (13.7) | 34.2 (14.7) |
| Mean CAT total score (SD) | 15.4 (4.9) | 15.4 (4.6) | 14.3 (4.0) | 13.9 (3.9) |
| Rescue medication usec | ||||
| N | 139 | 138 | 70 | 68 |
| Mean (SD) | 0.8 (1.3) | 0.7 (1.7) | 0.5 (1.2) | 0.5 (1.4) |
| Median (range), puffs/day | 0.0 (0.0–6.6) | 0.0 (0.0–12.1) | 0.0 (0.0–6.9) | 0.0 (0.0–8.0) |
Notes: aNumber of pack-years smoked = (number of cigarettes each day/20) x number of years smoked. bReversible is defined as improvement in FEV1 post-albuterol administration compared with pre-albuterol of ≥12% and ≥200 mL. cAssessed during the last seven days of the screening period.
Abbreviations: BDI, Baseline Dyspnea Index; BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; BUD/FORM DPI, budesonide/formoterol fumarate dry powder inhaler; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; GFF, glycopyrrolate/formoterol fumarate; ICS, inhaled corticosteroid; MDI, metered dose inhaler; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire.