Table 1 Baseline demographics and disease status (safety population)
From: Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease
ACCLAIM/COPD I | ACCLAIM/COPD II | |||
|---|---|---|---|---|
Aclidinium 200 μg (n = 627) | Placebo (n = 216) | Aclidinium 200 μg (n = 600) | Placebo (n = 204) | |
Age, mean (SD) years | 62.6 (8.2) | 61.9 (8.3) | 65.1 (8.6) | 65.2 (8.6) |
Male, n (%) | 488 (77.8) | 175 (81.0) | 383 (63.8) | 124 (60.8) |
Caucasian, n (%) | 627 (100.0) | 215 (99.5) | 552 (92.0) | 189 (92.7) |
BMI, mean (SD), kg/m2 | 26.4 (4.70) | 26.7 (4.65) | 26.8 (5.9) | 26.6 (6.1) |
Current smoker, n (%) | 283 (45.1) | 98 (45.4) | 222 (37.0) | 79 (38.7) |
Smoking history, mean (SD) pack-years | 40.4 (21.0) | 38.4 (18.3) | 57.8 (29.9) | 58.2 (28.4) |
Post-bronchodilator FEV1, mean (SD) % of predicted value | 54.2 (15.1) | 52.9 (15.2) | 50.6 (15.6) | 49.4 (15.1) |
Post-bronchodilator FEV1/FVC ratio, mean (SD) % | 49.2 (11.4) | 48.9 (11.1) | 48.0 (11.7) | 47.1 (11.9) |
Bronchodilator reversibility, mean (SD) % | 12.3 (14.2) | 12.9 (14.0) | 17.7 (15.7) | 17.3 (13.5) |
Pre-dose FEV1 on Day 1, mean (SD) L | 1.413 (0.514) | 1.385 (0.509) | 1.214 (0.489) | 1.154 (0.479) |
SGRQ total score, mean (SD) | 47.3 (17.6) | 47.3 (18.0) | 45.2 (16.8) | 47.1 (16.3) |
Baseline Dyspnoea Index focal score, mean (SD) | 6.3 (2.2) | 6.4 (2.2) | 6.5 (2.3) | 6.2 (2.3) |
Pre-study COPD medication, n (%) | 532 (84.9) | 178 (82.4) | 505 (84.2) | 177 (86.8) |
Inhaled corticosteroids | 239 (38.1) | 83 (38.4) | 228 (38.0) | 78 (38.2) |
Long-acting β2-agonists | 99 (15.8) | 34 (15.7) | 38 (6.3) | 14 (16.9) |
Long-acting β2-agonists + inhaled corticosteroids* | 170 (27.1) | 47 (21.8) | 217 (36.2) | 76 (27.3) |
Long-acting muscarinic antagonist | 110 (17.5) | 39 (18.1) | 103 (17.2) | 37 (18.1) |
Short-acting β2-agonists | 331 (52.8) | 95 (44.0) | 408 (68.0) | 143 (70.1) |
Short-acting β2-agonists + short-acting muscarinic agents | 98 (15.6) | 45 (20.8) | 55 (9.2) | 25 (12.3) |
Short-acting muscarinic agents | 99 (15.8) | 26 (12.0) | 51 (8.5) | 28 (13.7) |
Xanthines | 116 (18.5) | 34 (15.7) | 29 (4.8) | 6 (2.9) |
Patients with ≥1 self-reported COPD exacerbation in previous year, n (%)† | 354 (56.5) | 131 (60.6) | 182 (30.3) | 64 (31.4) |