Table 1.
Baseline demographics and disease characteristics (randomized set)
| Variable | Glycopyrrolate, N=222 | Placebo, N=219 |
|---|---|---|
| Age, years | 62.7 (8.36) | 62.1 (8.34) |
| Men, n (%) | 124 (55.9) | 132 (60.3) |
| Caucasian, n (%) | 205 (92.3) | 193 (88.1) |
| Smoking status at baseline, n (%) | ||
| Ex-smoker | 85 (38.3) | 87 (39.7) |
| Current smoker | 137 (61.7) | 132 (60.3) |
| Severity of COPD,a airflow limitation, n (%) | ||
| GOLD 2 | 138 (62.2) | 144 (65.8) |
| GOLD 3 | 83 (37.4) | 73 (33.3) |
| Severity of COPD,a combined assessment of COPD, n (%) | ||
| GOLD B | 136 (61.3) | 137 (62.6) |
| GOLD D | 85 (38.3) | 80 (36.5) |
| Duration of COPD, years | 6.6 (4.85) | 6.8 (5.45) |
| Number of COPD exacerbations in the previous year, n (%) | ||
| 0 | 174 (78.4) | 165 (75.3) |
| 1 | 42 (18.9) | 41 (18.7) |
| ≥2 | 6 (2.7) | 13 (5.9) |
| ICS use at baseline, n (%) | 54 (24.3) | 62 (28.3) |
| mMRC dyspnea scale, n (%) | ||
| Grade 2 | 121 (54.5) | 113 (51.6) |
| Grade 3 | 88 (39.6) | 92 (42.0) |
| Grade 4 | 12 (5.4) | 13 (5.9) |
| BDI focal score | 5.72 (2.10) | 5.6 (2.06) |
| SGRQ total score | 52.4 (17.20) | 54.1 (16.84) |
| CAT score | 20.4 (8.07) | 20.7 (7.54) |
| Prebronchodilator FEV1, L | 1.28 (0.490) | 1.33 (0.502) |
| Postbronchodilator FEV1, L | 1.52 (0.540) | 1.58 (0.541) |
| Postbronchodilator FEV1, % predicted | 54.2 (13.59) | 55.7 (12.78) |
| Postbronchodilator FEV1 reversibility, %b | 20.7 (14.90) | 20.7 (14.98) |
Notes:
a
GOLD 2011; all data shown are presented as mean (standard deviation), unless specified;
b
assessed after administration of 84 µg ipratropium bromide.
Abbreviations: BDI, baseline dyspnea index; CAT, COPD assessment test; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; mMRC, modified Medical Research Council; SGRQ, St George’s Respiratory Questionnaire; GOLD, Global Initiative for Chronic Obstructive Lung Disease.