Table 1.
Baseline demographics (mITT population)
| Parameter | GFF MDI | GP MDI 36 μg (N = 41) | Open-label tiotropium 18 μg (N = 58) | FF MDI | Placebo MDI (N = 52) | Open-label FFa DPI 12 μg (N = 55) | ||
|---|---|---|---|---|---|---|---|---|
| 72/9.6 μg (N = 41) | 36/9.6 μg (N = 43) | 9.6 μg (N = 64) | 7.2 μg (N = 64) | |||||
| Age, years | ||||||||
| Mean (SD) | 62.4 (9.4) | 63.3 (8.3) | 66.3 (6.1) | 64.1 (7.9) | 63.4 (8.9) | 63.6 (8.9) | 62.8 (9.6) | 60.6 (9.0) |
| Gender, n (%) | ||||||||
| Male | 25 (61.0) | 24 (55.8) | 23 (56.1) | 34 (58.6) | 34 (53.1) | 36 (56.3) | 29 (55.8) | 34 (61.8) |
| Race, n (%) | ||||||||
| Black/African | 0 | 0 | 0 | 0 | 3 (4.7) | 3 (4.7) | 3 (5.8) | 3 (5.5) |
| White | 39 (95.1) | 42 (97.7) | 41 (100) | 57 (98.3) | 61 (95.3) | 61 (95.3) | 48 (92.3) | 52 (94.5) |
| Australia/New Zealand (indigenous) | 2 (4.9) | 1 (2.3) | 0 | 1 (1.7) | 0 | 0 | 1 (1.9) | 0 |
| Smoking status, n (%) | ||||||||
| Current | 16 (39.0) | 18 (41.9) | 15 (36.6) | 24 (41.4) | 29 (45.3) | 28 (43.8) | 24 (46.2) | 25 (45.5) |
| Former | 25 (61.0) | 25 (58.1) | 26 (63.4) | 34 (58.6) | 35 (54.7) | 36 (56.3) | 28 (53.8) | 30 (54.5) |
| Duration of COPD, years | ||||||||
| Mean (SD) | 7.6 (7.3)b | 6.2 (5.4)c | 7.8 (6.2)b | 7.4 (6.7)d | 8.6 (6.1)e | 7.7 (4.4)f | 8.3 (5.2)g | 7.3 (4.3)h |
| Mean % predicted FEV1 (SD) | ||||||||
| Pre-bronchodilator | 44.1 (13.9)b | 46.8 (14.1)c | 45.8 (13.5)b | 44.9 (13.9)d | 44.7 (12.6)e | 43.9 (12.0)f | 43.7 (11.6)g | 44.0 (13.3)h |
| Post-bronchodilator | 50.6 (13.0)b | 53.0 (13.1)c | 51.5 (13.3)b | 51.3 (13.4)d | 51.4 (12.5)e | 50.2 (12.6)f | 51.1 (12.4)g | 50.9 (12.9)h |
| Mean FEV1, L (SD) | ||||||||
| Pre-bronchodilator | 1.33 (0.48)b | 1.38 (0.47)c | 1.30 (0.41)b | 1.33 (0.47)d | 1.29 (0.43)e | 1.28 (0.40)f | 1.30 (0.41)g | 1.35 (0.46)h |
| Post-bronchodilator | 1.52 (0.47)b | 1.56 (0.47)c | 1.46 (0.40)b | 1.51 (0.46)d | 1.49 (0.46)e | 1.47 (0.43)f | 1.52 (0.47)g | 1.56 (0.48)h |
| FEV1 bronchodilator reversibility, L (SD)i | ||||||||
| Mean (SD) | 17.8 (16.3)b | 16.3 (17.2)c | 14.2 (14.5)b | 17.1 (16.2)d | 17.5 (14.7)e | 15.9 (12.7)f | 18.6 (12.9)g | 18.5 (15.5)h |
aForadil® Aerolizer®; b n = 38; c n = 39; d n = 56; e n = 58; f n = 63; g n = 45; h n = 54; ipercentage change from pre-albuterol at 30 min post-albuterol for FEV1
% = 100 × n/N, where n = number of patients in category and N = number of patients in the group
Duration of COPD = (date of first dose of study treatment in the study – COPD onset date)/365.25
Data from four sentinel patients were included in the mITT population in the analyses of demographic and baseline characteristics only
COPD chronic obstructive pulmonary disease, DPI dry powder inhaler, FEV 1 forced expiratory volume in 1 s, FF formoterol fumarate, GFF glycopyrrolate/formoterol fumarate, GP glycopyrrolate, MDI metered dose inhaler, mITT modified intent-to-treat, SD standard deviation