Table 1.
Screening demographics and disease characteristics (safety set)
| Characteristic | Patients (N = 106) |
|---|---|
| Age, years | 65.4 (7.2) |
| Sex, male | 66 (62.3%) |
| Race, white | 106 (100%) |
| Body-mass index, kg/m2 | 27.13 (4.36) |
| Smoking status | |
| Ex-smoker | 47 (44.3%) |
| Current smoker | 59 (55.7%) |
| Time since diagnosis, years | 10.39 (7.93) |
| At least one COPD exacerbation in prior 12 months | 16 (15.1%) |
| COPD maintenance therapy at study entry | |
| LABA/LAMA | 74 (69.8%) |
| ICS/LABA | 14 (13.2%) |
| LABA | 4 (3.8%) |
| LAMA | 5 (4.7%) |
| SABA | 8 (7.5%) |
| SAMA | 1 (0.9%) |
| Post-bronchodilator FEV1 | |
| Absolute, L | 1.793 (0.495) |
| Percent predicted | 60.60 (12.10) |
| GOLD Stage* | |
| 1 (FEV1 ≥ 80% predicted) | 4 (3.8%) |
| 2 (FEV1 < 80% and ≥ 50% predicted) | 75 (70.8%) |
| 3 (FEV1 < 50% and ≥ 30% predicted) | 25 (23.6%) |
| 4 (FEV1 < 30% predicted) | 1 (0.9%) |
| Missing | 1 (0.9%) |
| Post-bronchodilator FVC, L | 3.470 (0.937) |
| Post-bronchodilator FEV1/FVC | 0.526 (0.106) |
| FRC, L | |
| Absolute, L | 4.745 (0.983) |
| Percent predicted | 144.8 (26.0) |
| TLC, L | |
| Absolute, L | 6.830 (1.476) |
| Percent predicted† | 110.2 (20.1) |
| RV, L | |
| Absolute, L | 3.609 (1.008) |
| Percent predicted† | 156.3 (42.9) |
| RV/TLC | 0.528 (0.112) |
| Modified medical research council dyspnoea scale | 2.2 (0.4) |
| Constant work-rate cycle ergometry training test | |
| Reason for termination | |
| Dyspnoea | 27 (25.5%) |
| Leg | 18 (17.0%) |
| Leg/dyspnoea | 55 (51.9%) |
| Other | 6 (5.7%) |
| Inspiratory capacity, pre-exercise, L | 2.205 (0.804) |
| Modified Borg dyspnoea scale at end exercise | 6.86 (2.77) |
| Exercise endurance time, min | 6.12 (2.94) |
*The GOLD Stage data are based on the spirometry assessment conducted at the screening visit. If a patient did not meet the spirometry inclusion criterion at this visit (i.e., post-bronchodilator FEV1 was not between 40% and 80% predicted), the test could be repeated once prior to the randomisation visit; the patient was randomised only if the inclusion criterion was then met. †The TLC and RV percent predicted data were derived post-hoc based on formulae in Stocks and Quanjer [28]. Data are mean (standard deviation) or number (percent). LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; ICS, inhaled corticosteroid; SABA, short-acting β2-agonist; SAMA, short-acting muscarinic antagonist; FEV1, forced expiratory volume in 1 s; GOLD, Global Initiative for Chronic Obstructive Lung Disease; FVC, forced vital capacity; FRC, functional residual capacity; TLC, total lung capacity; RV, residual volume; RV/TLC, residual volume to total lung capacity ratio