Demographics and baseline clinical characteristics (ITT population)
| ACCORD COPD I | ATTAIN | Active-comparator study | |||||
|---|---|---|---|---|---|---|---|
| Characteristic | Placebo (N=185) | Aclidinium 400 µg twice daily (N=190) | Placebo (N=273) | Aclidinium 400 µg twice daily (N=269) | Placebo (N=85) | Aclidinium 400 µg twice daily (N=171) | Tiotropium 18 µg once daily (N=158) |
| Age (years), mean (SD) | 65.0 (9.2) | 64.9 (9.5) | 62.0 (8.0) | 62.9 (8.4) | 62.2 (8.2) | 61.8 (8.2) | 62.8 (7.9) |
| Gender (male), n (%) | 95 (51.4) | 100 (52.6) | 189 (69.2) | 182 (67.7) | 48 (56.5) | 114 (66.7) | 116 (73.4) |
| Current smoker, n (%) | 87 (47.0) | 80 (42.1) | 144 (52.8) | 148 (55.0) | 47 (55.3) | 93 (54.4) | 84 (53.2) |
| Smoking history (pack-years), mean (SD) | 52.9 (28.1) | 57.2 (28.5) | 38.9 (18.3) | 41.7 (21.1) | 39.6 (15.4) | 41.5 (22.4) | 45.0 (21.8) |
| Postbronchodilator FEV1,* mean (SD), L | 1.6 (0.6) | 1.5 (0.5) | 1.6 (0.5) | 1.6 (0.5) | 1.6 (0.5) | 1.6 (0.5) | 1.7 (0.5) |
| Postbronchodilator FEV1% predicted,* mean (SD) | 54.7 (13.4) | 54.1 (12.9) | 56.6 (12.8) | 56.2 (12.2) | 55.5 (11.8) | 55.8 (13.3) | 56.0 (13.2) |
| Severity of airflow limitation,†,‡ n (%) | |||||||
| Moderate | 111 (60.0) | 118 (62.1) | 178 (65.9) | 184 (68.7) | 58 (68.2) | 108 (63.2) | 104 (66.2) |
| Severe | 72 (38.9) | 68 (35.8) | 92 (34.1) | 84 (31.3) | 27 (31.8) | 63 (36.8) | 53 (33.8) |
| ≥1 COPD exacerbation in previous year,‡ n (%) | 52 (28.1) | 43 (22.6) | 88 (32.6) | 97 (36.2) | 19 (22.4) | 61 (35.7) | 47 (29.7) |
| Concomitant use of ICS, n (%) | 70 (37.6) | 81 (42.6) | 145 (53.1) | 128 (47.6) | 36 (42.4) | 82 (48.0) | 67 (42.4) |
*At screening visit.
†Moderate COPD: 50% ≤postbronchodilator FEV1 <80% predicted and FEV1/FVC <0.70; severe COPD: 30% ≤postbronchodilator FEV1 <50% predicted and FEV1/FVC <0.70.
‡Patients with available data.
COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; ICS, inhaled corticosteroid; ITT, intent-to-treat.