Table 1.
Baseline demographics, background characteristics, and spirometry (safety population)
| IND + GLY (N=226) | IND + PBO (N=221) | |
|---|---|---|
| Mean (SD) age, years | 63.4 (8.44) | 64.1 (7.67) |
| Male, n (%) | 180 (79.6) | 186 (84.2) |
| Ethnicity, n (%) | ||
| Caucasian | 224 (99.1) | 217 (98.2) |
| Native American | 0 | 1 (0.5) |
| Other | 2 (0.9) | 3 (1.4) |
| Severity of airflow limitation (GOLD 2013), n (%) | ||
| Moderate | 139 (61.5) | 148 (67.0) |
| Severe | 87 (38.5) | 73 (33.0) |
| Mean (SD) duration of COPD, years | 7.1 (5.65) | 7.2 (5.35) |
| Baseline COPD exacerbation history,* n (%) | ||
| 0 exacerbations | 158 (69.9) | 156 (70.6) |
| 1 exacerbation | 57 (25.2) | 46 (20.8) |
| ≥2 exacerbations | 11 (4.9) | 19 (8.6) |
| ICS use at baseline, n (%) | 138 (61.1) | 142 (64.3) |
| Smoking history, n (%) | ||
| ≥Ex-smoker | 130 (57.5) | 129 (58.4) |
| ≥Current smoker | 96 (42.5) | 92 (41.6) |
| Mean (SD) duration of smoking, pack-years | 44.5 (23.40) | 44.4 (22.24) |
| Mean (SD) FEV1 postbronchodilator, L | 1.5 (0.46) | 1.6 (0.46) |
| Mean (SD) postbronchodilator FEV1 % predicted | 54.2 (12.90) | 55.5 (12.62) |
| Mean (SD) postbronchodilator FEV1 reversibility, % | 19.4 (14.82) | 19.6 (14.71) |
| Mean (SD) postbronchodilator FEV1/FVC, % | 48.8 (9.83) | 48.1 (10.21) |
Notes:
*
In the year prior to screening; duration of COPD calculated from the date first diagnosed with COPD until visit 1; pack-years = total years of smoking multiplied by cigarette packs smoked per day.
Abbreviations: COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GLY, glycopyrronium; GOLD, Global initiative for chronic Obstructive Lung Disease; ICS, inhaled corticosteroids; IND, indacaterol; PBO, placebo; SD, standard deviation.