TABLE 1.
Baseline demographics and patient characteristics at rest and at the end of constant work-rate cycle ergometry (CWRCE) (treated set, combined data)#
| Patients | 586 |
| Male | 417 (71.2) |
| Race | |
| Black/African-American | 12 (2.0) |
| Asian | 2 (0.3) |
| White | 572 (97.6) |
| Age years | 61.7±7.7 |
| Body mass index kg·m–2 | 27.0±5.0 |
| Smoking status | |
| Ex | 357 (60.9) |
| Current | 229 (39.1) |
| Smoking history pack-years | 45.8±23.1 |
| Pre-bronchodilator screening | |
| FEV1 L | 1.550±0.497 |
| FEV1 % pred normal¶ | 52±14 |
| Post-bronchodilator screening | |
| FEV1 L | 1.721±0.497 |
| FEV1 % pred normal¶ | 58±13 |
| FEV1 change from pre-bronchodilator L | 0.17±0.16 |
| GOLD+ | |
| 1 (FEV1 % pred ≥80%) | 1 (0.2) |
| 2 (FEV1 % pred 50–<80%) | 416 (71.0) |
| 3 (FEV1 % pred 30–<50%) | 164 (28.0) |
| 4 (FEV1 % pred <30%) | 5 (0.9) |
| Inspiratory capacity pre-exercise L | 2.565±0.725 |
| Inspiratory capacity % pred¶ | 70.2±30.1 |
| Endurance time§ s | 511.6 (269.4) |
| Locus of symptom limitation at end-exercise (CWRCE) | |
| Breathing/leg discomfort | 235 (40.1) |
| Breathing discomfort | 207 (35.3) |
| Leg discomfort | 122 (20.8) |
| Breathing discomfort at end-exercise Borg scale | 6.67±2.42 |
| Leg discomfort at end-exercise Borg units | 6.45±2.63 |
| Cardiac disorder comorbidities at baselineƒ | 126 (21.5) |
| Angina pectoris | 15 (2.6) |
| Arrhythmia | 5 (0.9) |
| Arteriosclerosis coronary artery | 4 (0.7) |
| Bundle branch block left | 6 (1.0) |
| Bundle branch block right | 11 (1.9) |
| Chest pain | 4 (0.7) |
| Coronary artery disease | 21 (3.6) |
| Diastolic dysfunction | 3 (0.5) |
| Dizziness | 3 (0.5) |
| Dyspnoea | 5 (0.9) |
| Haemoptysis | 3 (0.5) |
| Left ventricular hypertrophy | 4 (0.7) |
| Mitral valve incompetence | 5 (0.9) |
| Myocardial infarction | 20 (3.4) |
| Myocardial ischaemia | 13 (2.2) |
| Oedema (peripheral) | 9 (1.5) |
| Palpitations | 3 (0.5) |
| Sinus bradycardia | 7 (1.2) |
| Tricuspid valve incompetence | 3 (0.5) |
Data are presented as n, n (%) or mean±sd. FEV1: forced expiratory volume in 1 s; GOLD: Global Initiative for Chronic Obstructive Lung Disease. #: individual study data are presented in supplementary table S1; ¶: based on predicted values defined by the European Community for Steel and Coal [26]. +: one patient with GOLD 1 disease was randomised to treatment (this was classed as a protocol violation and the patient was excluded from the per-protocol analysis set); five patients with GOLD 4 disease were randomised to treatment: two patients were enrolled prior to a protocol amendment that excluded patients with GOLD 4 disease (the original protocol did not include a lower limit for FEV1 % pred) and one patient had FEV1 % pred of 29.77%; these were not considered protocol violations; two patients with GOLD 4 disease were randomised after approval of the protocol amendment and were excluded from the per-protocol analysis set; §: arithmetic mean (not log-transformed); ƒ: coded according to the Medical Dictionary for Regulatory Activities version 16.1 (www.meddra.org) and occurring in ≥0.5% of patients at baseline.