| Baseline characteristic | Concomitant treatment | Exacerbations in the previous year# | ||||||
| With LABA | Without LABA | Infrequent (<2) | Frequent (≥2) | |||||
| Roflumilast | Placebo | Roflumilast | Placebo | Roflumilast | Placebo | Roflumilast | Placebo | |
| Subjects n | 749 | 793 | 788 | 761 | 1124 | 1137 | 413 | 417 |
| Age¶ yrs | 64.2±9.3 | 64.7±9.0 | 63.3±9.4 | 63.0±9.2 | 63.7±9.2 | 64.0±9.1 | 63.8±9.8 | 63.4±9.3 |
| Males | 558 (74.5) | 591 (74.5) | 592 (75.1) | 595 (78.2) | 853 (75.9) | 877 (77.1) | 297 (71.9) | 309 (74.1) |
| Smoking history¶ pack-yrs | 48.9±24.9 | 47.6±23.9 | 47.8±25.5 | 46.1±22.6 | 49.0±25.0 | 47.0±23.4 | 46.6±25.8 | 46.6±23.1 |
| Current smoker¶ | 286 (38.2) | 294 (37.1) | 349 (44.3) | 349 (45.9) | 470 (41.8) | 467 (41.1) | 165 (40.0) | 176 (42.2) |
| Pre-bronchodilator FEV1+ L | 1.0±0.4 | 1.0±0.3 | 1.0±0.4 | 1.0±0.4 | 1.0±0.4 | 1.03±0.4 | 1.0±0.4 | 0.97±0.3 |
| Post-bronchodilator FEV1+ L | 1.1±0.4 | 1.1±0.3 | 1.1±0.4 | 1.1±0.4 | 1.1±0.4 | 1.13±0.4 | 1.1±0.4 | 1.1±0.4 |
| Pre-bronchodilator FEV1+ % pred | 33.2±10.1 | 33.4±9.5 | 32.9±10.5 | 33.3±11.6 | 32.7±10.3 | 33.8±10.3 | 33.9±10.4 | 32.1±11.1 |
| Post-bronchodilator FEV1+ % pred | 35.7±10.5 | 35.9±9.7 | 36.5±10.7 | 36.8±11.7 | 35.9±10.5 | 37.0±10.7 | 36.7±10.9 | 34.6±10.7 |
| FEV1 reversibility increase+ % | 8.5±12.5 | 8.6±15.0 | 12.8±16.3 | 12.6±16.3 | 11.1±14.5 | 10.9±14.9 | 9.5±15.3 | 9.7±17.9 |
| Post-bronchodilator FEV1/FVC+ % | 42.1±11.0 | 41.4±10.5 | 42.5±11.4 | 42.6±11.3 | 41.8±11.0 | 42.1±10.8 | 43.5±11.6 | 41.6±11.2 |
| Body mass index+ kg·m−2 | 26.8±5.5 | 26.3±5.4 | 24.9±6.1 | 25.0±5.8 | 25.6±5.9 | 25.7±5.7 | 26.2±5.7 | 25.7±5.7 |
| COPD severity¶,§,,ƒ | ||||||||
| Severe | 452 (60.3) | 529 (66.7) | 491 (62.3) | 460 (60.4) | 697 (62.0) | 750 (66.0) | 246 (59.6) | 239 (57.3) |
| Very severe | 239 (31.9) | 218 (27.5) | 224 (28.4) | 222 (29.2) | 336 (29.9) | 289 (25.4) | 127 (30.8) | 151 (36.2) |
| Concomitant LABA## | 523 (46.5) | 546 (48.0) | 226 (54.7) | 247 (59.2) | ||||
| Concomitant SAMA## | 162 (21.6) | 178 (22.4) | 426 (54.1) | 438 (57.6) | 443 (39.4) | 448 (39.4) | 145 (35.1) | 168 (40.3) |
| Prior ICS¶¶ | 469 (62.6) | 476 (60.0) | 181 (23.0) | 181 (23.8) | 460 (40.9) | 462 (40.6) | 190 (46.0) | 195 (46.8) |
Data are presented as mean±sd or n (%), unless otherwise stated. Frequency of exacerbations in the previous year is based on patient recall. FEV1: forced expiratory volume in 1 s; % pred: % predicted; FVC: forced vital capacity; COPD: chronic obstructive pulmonary disease; SAMA: short-acting muscarinic antagonist; ICS: inhaled corticosteroid. #: post hoc analyses; ¶: measurements taken at the beginning of the run-in period; +: measurements taken at baseline; §: based on the criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD); ƒ: percentages do not sum to 100% as patients with mild or moderate COPD are not shown; ##: based on whether the patient had used medication at least once within the start and up to the end of the treatment period, inclusive; ¶¶: based on whether the patient had used ICS therapy at least once within the period starting the day after the first visit until the day before randomisation, inclusive.