Table 1.
Baseline demographics and disease characteristics (all randomised analysis set)
| 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) |
Data are mean (standard deviation) unless specified otherwise
aAvailable baseline data from 81, 81, 82, 80 and 79 patients, respectively
bAvailable baseline data from 75, 75, 77, 77 and 77, respectively
Abbreviations: FEV1 forced expiratory volume in 1 s, SGRQ-C St George’s Respiratory Questionnaire – COPD Specific, BDI Baseline Dyspnoea Index, MRC Medical Research Council dyspnoea scale, E-RS:COPD™ Evaluating Respiratory Symptoms in COPD questionnaire, COPD chronic obstructive pulmonary disease, ICS inhaled corticosteroid