Table 1.
Patient demographics in symptomatic patients (E-RS baseline score ≥10 units)
| Placebo (N=60) | Aclidinium 400 µg BID (N=116) | Tiotropium 18 µg QD (N=101) | |
|---|---|---|---|
| Gender (male), n (%) | 35 (58.3) | 75 (64.7) | 70 (69.3) |
| Age (years), mean (SD) | 62.1 (8.2) | 61.4 (8.4) | 62.9 (8.1) |
| Race, n (%) | |||
| White | 59 (98.3) | 116 (100) | 101 (100) |
| BMI (kg/m2), mean (SD) | 26.8 (5.4) | 27.4 (4.9) | 27.1 (4.8) |
| Current smoker, n (%) | 31 (51.7) | 64 (55.2) | 56 (55.5) |
| Smoking consumption (pack-years), mean (SD) | 38.8 (14.3) | 41.7 (23.7) | 42.4 (17.1) |
| COPD duration (years), mean (SD) | 9.63 (6.7) | 8.44 (5.8) | 8.44 (6.6) |
| Post-bronchodilator FEV1 (L) | |||
| Mean (SD) | 1.56 (0.54) | 1.59 (0.50) | 1.53 (0.49) |
| % predicted, mean (SD) | 55.2 (12.1) | 55.5 (13.4) | 53.0 (13.1) |
| Mean bronchial reversibility, % (SD) | 10.1 (9.7) | 14.7 (15.2) | 10.8 (12.8) |
| COPD severity,a n (%) | |||
| Moderate | 40 (66.7) | 72 (62.1) | 56 (56.0) |
| Severe | 20 (33.3) | 44 (37.9) | 44 (44.0) |
| Exacerbations in previous year, n (%) | |||
| 0 | 46 (76.7) | 75 (64.7) | 67 (66.3) |
| 1 | 12 (20.0) | 31 (26.7) | 30 (29.7) |
| ≥2 | 2 (3.3) | 10 (8.6) | 4 (4.0) |
| E-RS Total score (SD) | 16.2 (4.3) | 16.4 (4.2) | 15.8 (3.8) |
| E-RS Cough and Sputum (SD) | 4.3 (1.6) | 4.5 (1.4) | 4.4 (1.1) |
| E-RS Chest Symptoms (SD) | 3.9 (1.3) | 4.0 (1.4) | 3.7 (1.3) |
| E-RS Breathlessness (SD) | 8.0 (2.5) | 7.9 (2.5) | 7.7 (2.5) |
| Severity of early-morning symptoms | |||
| Any (SD) | 2.5 (0.5) | 2.6 (0.5) | 2.5 (0.5) |
| Cough (SD) | 1.4 (0.8) | 1.5 (0.7) | 1.4 (0.7) |
| Wheeze (SD) | 0.9 (0.9) | 0.9 (0.8) | 0.8 (0.7) |
| Shortness of breath (SD) | 1.3 (0.7) | 1.3 (0.8) | 1.1 (0.8) |
| Phlegm (SD) | 0.8 (0.9) | 1.1 (0.9) | 0.9 (0.9) |
| Limitation of activity (SD) | 2.3 (0.6) | 2.3 (0.6) | 2.3 (0.7) |
| Severity of nighttime symptoms (SD) | 2.1 (0.7) | 2.2 (0.6) | 2.1 (0.6) |
Notes:
a
GOLD stage II (moderate): FEV1/FVC <0.70, and post-bronchodilator FEV1 ≥50% and <80% predicted; GOLD stage III (severe): FEV1/FVC <0.70, and post-bronchodilator FEV1 ≥30% and <50% predicted.
Abbreviations: BID, twice daily; BMI, body mass index; E-RS, Evaluating Respiratory Symptoms; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GOLD, Global initiative for chronic Obstructive Lung Disease; QD, once daily; SD, standard deviation.