Table 1.
Baseline demographics and spirometry (full analysis set)
| Glycopyrronium +SAL/FP |
Tiotropium +SAL/FP |
Placebo +SAL/FP |
|
|---|---|---|---|
| N=257 | N=258 | N=257 | |
| Mean (SD) age, years | 68.2 (8.38) | 68.0 (7.74) | 67.8 (8.49) |
| Male, n (%) | 163 (63.4) | 160 (62.0) | 174 (67.7) |
| Race, n (%) | |||
| Caucasian | 247 (96.1) | 242 (93.8) | 250 (97.3) |
| Asian | 1 (0.4) | 4 (1.6) | 1 (0.4) |
| Pacific Islander | 3 (1.2) | 3 (1.2) | 3 (1.2) |
| Black | 0 | 1 (0.4) | 0 |
| Other | 6 (2.3) | 8. (3.1) | 3 (1.2) |
| Mean (SD) duration of COPD, years | 7.0 (7.29) | 6.5 (5.82) | 7.2 (6.57) |
| Severity of COPD (GOLD 2010), n (%) | |||
| Moderate | 172 (66.9) | 175 (67.8) | 176 (68.5) |
| Severe | 85 (33.1) | 83 (32.2) | 81 (31.5) |
| Presence of exacerbation in past year, n (%) | |||
| Yes | 90 (35.0) | 92 (35.7) | 87 (33.9) |
| No | 167 (65.0) | 166 (64.3) | 170 (66.1) |
| ICS use at baseline | 161 (62.6) | 171 (66.3) | 175 (68.1) |
| LABA/ICS | 144 (56) | 154 (59.7) | 152 (59.1) |
| Other ICS | 17 (6.6) | 17 (6.6) | 23 (8.9) |
| Smoking status at screening, n (%) | |||
| Ex-smoker | 166 (64.6) | 166 (64.3) | 164 (63.8) |
| Smoker | 91 (35.4) | 92 (35.7) | 93 (36.2) |
| Mean (SD) duration of smoking, pack years | 47.2 (24.29) | 49.4 (26.98) | 49.7 (27.33) |
| Mean (SD), post-bronchodilator FEV1, L | 1.52 (0.50) | 1.49 (0.47) | 1.55 (0.48) |
| Mean (SD), post-bronchodilator FEV1% predicted | 57.36 (13.98) | 56.86 (13.81) | 57.35 (13.64) |
| Mean (SD), post-bronchodilator FEV1 reversibility, % | 21.10 (16.49) | 23.45 (16.50) | 22.41 (14.65) |
| Mean (SD), post-bronchodilator FEV1/FVC, % | 47.90 (11.01) | 46.68 (10.99) | 46.64 (11.26) |
COPD, chronic obstructive pulmonary disease; FP, fluticasone propionate; ICS, inhaled corticosteroid; LABA, long-acting β2 agonist; SAL, salmeterol.