Table 1 Baseline demographics and clinical characteristics (safety population)
From: A novel model-based approach for dose determination of glycopyrronium bromide in COPD
Glycopyrronium bromide 12.5 μg OD (n = 89) | Glycopyrronium bromide 25 μg OD (n = 96) | Glycopyrronium bromide 12.5 μg BID (n = 96) | Glycopyrronium bromide 50 μg OD (n = 92) | Glycopyrronium bromide 25 μg BID (n = 96) | Glycopyrronium bromide 100 μg OD (n = 96) | Glycopyrronium bromide 50 μg BID (n = 87) | Placebo (n = 91) | |
|---|---|---|---|---|---|---|---|---|
Age (years), mean (SD) | 60.2 (7.77) | 60.0 (7.98) | 60.9 (7.89) | 59.2 (8.14) | 61.2 (7.80) | 62.1 (7.83) | 62.2 (7.74) | 63.2 (7.67) |
Range | 47-79 | 43-81 | 40-80 | 43-80 | 40-80 | 40-79 | 49-81 | 48-78 |
Sex, n (%) | ||||||||
Male | 56 (62.9) | 64 (66.7) | 67 (69.8) | 56 (60.9) | 66 (68.8) | 59 (61.5) | 59 (67.8) | 56 (61.5) |
Smoking history, n (%) | ||||||||
Ex-smoker | 45 (50.6) | 51 (52.1) | 50 (52.1) | 45 (48.9) | 50 (52.1) | 57 (59.4) | 48 (55.2) | 52 (57.1) |
Current smoker | 44 (49.4) | 45 (46.9) | 46 (47.9) | 47 (51.1) | 46 (47.9) | 39 (40.6) | 39 (44.8) | 39 (42.9) |
Pack-years, mean (SD) | 43.2 (23.05) | 39.6 (19.97) | 40.9 (19.88) | 39.3 (19.91) | 42.8 (23.26) | 39.8 (19.79) | 42.1 (21.17) | 40.4 (20.84) |
FEV1 pre-bronchodilator (% predicted), n (%) | ||||||||
47 (12) | 46 (11) | 46 (14) | 46 (11) | 45 (12) | 46 (14) | 48 (13) | 48 (13) | |
FEV1 post-bronchodilator (% predicted), n (%) | ||||||||
30- < 50% | 34 (38.2) | 36 (37.5) | 44 (45.8) | 34 (37.0) | 43 (44.8) | 44 (45.8) | 34 (39.1) | 37 (40.7) |
50- < 80% | 55 (61.8) | 60 (62.5) | 52 (54.2) | 58 (63.0) | 53 (55.2) | 52 (54.2) | 53 (60.9) | 54 (59.3) |
FEV1 reversibility,% | ||||||||
Mean (SD) | 17 (12) | 19 (16) | 16 (14) | 17 (12) | 16 (12) | 17 (18) | 16 (16) | 16 (16) |
Median (range) | 16 (−11-44) | 19 (−16-90) | 16 (−43-55) | 18 (−18-40) | 15 (−13-44) | 16 (−43-72) | 14 (−21-90) | 13(−21-72) |
FEV1/FVC (%) post-bronchodilator (%), mean (SD) | ||||||||
46.87 (10.36) | 46.76 (8.66) | 45.86 (11.12) | 46.41 (9.29) | 46.15 (10.21) | 47.21 (11.72) | 47.89 (9.57) | 48.22 (10.65) | |