Demographic and baseline patient characteristics (treated population): combined data (n=5162)
| Olodaterol 5 µg | Tiotropium 2.5 µg | Tiotropium 5 µg | Tiotropium+olodaterol 2.5/5 µg | Tiotropium+olodaterol 5/5 µg | |
| Participants n | 1038 | 1032 | 1033 | 1030 | 1029 |
| Male | 764 (73.6) | 753 (73.0) | 755 (73.1) | 757 (73.5) | 733 (71.2) |
| Age years | 64.2±8.2 | 64.0±8.7 | 63.9±8.6 | 64.1±7.8 | 63.8±8.3 |
| Smoking status | |||||
| Ex-smoker | 660 (63.6) | 644 (62.4) | 663 (64.2) | 658 (63.9) | 629 (61.1) |
| Current smoker | 378 (36.4) | 388 (37.6) | 370 (35.8) | 372 (36.1) | 400 (38.9) |
| Co-morbidities | 897 (86.4) | 884 (85.7) | 902 (87.3) | 889 (86.3) | 890 (86.5) |
| Cardiac | 234 (22.5) | 212 (20.5) | 219 (21.2) | 229 (22.2) | 213 (20.7) |
| Vascular | 511 (49.2) | 475 (46.0) | 513 (49.7) | 486 (47.2) | 496 (48.2) |
| Pre-bronchodilator screening FEV1 mL | 1209±505 | 1218±489 | 1200±504 | 1208±473 | 1180±493 |
| Post-bronchodilator screening FEV1 mL | 1377±520 | 1393±511 | 1370±521 | 1385±496 | 1344±505 |
| Change from pre- to post-bronchodilator FEV1 mL | 168±143 | 174±150 | 171±146 | 177±138 | 164±148 |
| FEV1/FVC % | 45.0±11.6 | 45.1±11.6 | 45.0±12.0 | 44.6±11.5 | 45.1±11.6 |
| FEV1 % pred | 50.3±15.6 | 50.3±15.0 | 49.7±15.7 | 50.2±14.9 | 49.3±15.3 |
| GOLD stage# | |||||
| 1 (FEV1 ≥80% pred) | 0 (0.0) | 1 (0.1) | 1 (0.1) | 1 (0.1) | 0 (0.0) |
| 2 (FEV1 50–<80% pred) | 532 (51.3) | 518 (50.2) | 517 (50.0) | 519 (50.4) | 502 (48.8) |
| 3 (FEV1 30–<50% pred) | 378 (36.4) | 409 (39.6) | 387 (37.5) | 407 (39.5) | 408 (39.7) |
| 4 (FEV1 <30% pred) | 128 (12.3) | 103 (10.0) | 128 (12.4) | 103 (10.0) | 119 (11.6) |
| Baseline pulmonary medication | |||||
| SAMA¶ | 134 (12.9) | 140 (13.6) | 131 (12.7) | 135 (13.1) | 125 (12.1) |
| LAMA+ | 365 (35.2) | 348 (33.7) | 346 (33.5) | 403 (39.1) | 378 (36.7) |
| SABA§ | 424 (40.8) | 433 (42.0) | 401 (38.8) | 421 (40.9) | 400 (38.9) |
| LABAƒ | 491 (47.3) | 475 (46.0) | 450 (43.6) | 491 (47.7) | 486 (47.2) |
| ICS## | 505 (48.7) | 476 (46.1) | 466 (45.1) | 493 (47.9) | 506 (49.2) |
| Xanthines¶¶ | 96 (9.2) | 94 (9.1) | 109 (10.6) | 109 (10.6) | 108 (10.5) |
| Baseline cardiovascular medication | 620 (59.7) | 580 (56.2) | 596 (57.7) | 599 (58.2) | 581 (56.5) |
| β-blockers | 102 (9.8) | 119 (11.5) | 109 (10.6) | 117 (11.4) | 110 (10.8) |
Data are presented as n (%) or mean±sd, unless otherwise stated. FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; % pred: % predicted; GOLD: Global initiative for chronic Obstructive Lung Disease; SAMA: short-acting muscarinic antagonist; LAMA: long-acting muscarinic antagonist; SABA: short-acting β-agonist; LABA: long-acting β2-agonist; ICS: inhaled corticosteroid. #: based on post-bronchodilator FEV1 percentage predicted. In Study 1237.6, 1 patient on tiotropium 2.5 µg was not categorised; ¶: ipratropium, ipratropium/fenoterol or ipratropium/salbutamol, oxitropin; +: tiotropium; §: all patients received SABAs as rescue medication; ƒ: including arformoterol, formoterol, indacaterol, fenoterol and salmeterol; ##: including beclomethasone, budesonide, ciclesonide, mometasone furoate/formoterol fumarate hihydrate, fluticasone, formoterol/beclomethasone, formoterol/budesonide, mometasone, mometasone furoate, salmeterol/fluticasone; ¶¶: including aminophylline, theophylline.