From: A dose-ranging study of the inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in COPD
Ensifentrine | Placebo (N = 80) | ||||
---|---|---|---|---|---|
0.75 mg (N = 82) | 1.5 mg (N = 81) | 3 mg (N = 82) | 6 mg (N = 80) | ||
Age, years | 63.6 (7.05) | 63.4 (6.40) | 62.5 (6.51) | 62.9 (6.73) | 63.5 (6.44) |
Sex, n (%) | |||||
Male | 56 (68) | 46 (57) | 45 (55) | 48 (60) | 50 (63) |
Female | 26 (32) | 35 (43) | 37 (45) | 32 (40) | 30 (38) |
Race, n (%) | |||||
White | 82 (100) | 81 (100) | 82 (100) | 80 (100) | 80 (100) |
Post-bronchodilator FEV1 | |||||
L | 1.67 (0.464) | 1.60 (0.466) | 1.62 (0.441) | 1.63 (0.474) | 1.69 (0.493) |
% predicted | 56.0 (10.34) | 56.0 (9.83) | 55.6 (10.18) | 55.3 (9.47) | 56.0 (9.89) |
FEV1 reversibility, % | 10.4 (10.13) | 11.0 (12.32) | 12.9 (13.53) | 12.3 (11.14) | 11.7 (10.60) |
Smoking status, n (%) | |||||
Current | 50 (61) | 40 (49) | 47 (57) | 42 (53) | 43 (54) |
Ex | 32 (39) | 41 (51) | 35 (43) | 38 (48) | 37 (46) |
Smoking history, pack-years | 44.7 (21.27) | 43.7 (21.98) | 41.8 (19.05) | 37.3 (16.75) | 43.3 (20.21) |
Chronic bronchitis, n (%) | 48 (59) | 43 (53) | 56 (68) | 58 (73) | 46 (58) |
SGRQ-C | 49.9 (17.36) | 43.4 (17.06) | 42.1 (18.78) | 44.1 (15.02) | 42.3 (17.07) |
BDI | 5.9 (1.44) | 6.4 (1.81) | 6.4 (1.43) | 6.4 (1.16) | 6.4 (1.38) |
MRC | 2.8 (0.82) | 2.5 (0.79) | 2.5 (0.79) | 2.6 (0.73) | 2.5 (0.75) |
MRC score, n (%) | |||||
< 2 | 4 (5) | 8 (10) | 6 (7) | 4 (5) | 4 (5) |
≥ 2 | 78 (95) | 73 (90) | 76 (93) | 76 (95) | 76 (95) |
Rescue medication, puffs per daya | 1.5 (1.80) | 1.5 (1.84) | 1.9 (2.14) | 1.9 (2.13) | 1.5 (1.88) |
E-RS:COPD™b | 13.6 (6.77) | 12.3 (6.05) | 12.0 (6.03) | 12.2 (6.29) | 11.5 (6.23) |
Concomitant ICS use, n (%) | 33 (40) | 36 (44) | 29 (35) | 32 (40) | 28 (35) |