Table 1 Demographics and baseline characteristics
Pooled study population | M2-111 | M2-112 | ||||
|---|---|---|---|---|---|---|
Characteristics | Roflumilast | Placebo | Roflumilast | Placebo | Roflumilast | Placebo |
No. of patients | 1327 | 1359 | 567 | 606 | 760 | 753 |
Age (years) | 64.7 (9.2) | 64.4 (8.9) | 64 (8.7) | 64 (8.8) | 65 (9.6) | 64 (9.1) |
Male sex, n (%) | 958 (72.2) | 974 (71.7) | 387 (68.3) | 400 (66.0) | 571 (75.1) | 574 (76.2) |
Body mass index, kg/m2 | 25.7 (5.3) | 25.7 (5.4) | 26.0 (5.7) | 25.8 (5.7) | 25.4 (5.0) | 25.6 (5.1) |
Smoking status | ||||||
Current smokers, n (%) | 529 (40) | 530 (39) | 240 (42) | 265 (44) | 289 (38) | 265 (35) |
Former smokers, n (%) | 798 (60) | 829 (61) | 327 (58) | 341 (56) | 471 (62) | 488 (65) |
Pack-years (± SD) | 46 (25.6) | 48 (26.6) | 50 (28.2) | 51 (26.7) | 42 (22.9) | 45 (26.2) |
Pre-bronchodilator FEV1 (L) | 1.0 (0.4) | 1.0 (0.3) | 0.96 (0.4) | 0.93 (0.3) | 1.04 (0.4) | 1.06 (0.3) |
Post-bronchodilator FEV1 (L) | 1.13 (0.4) | 1.13 (0.4) | 1.12 (0.4) | 1.09 (0.4) | 1.13 (0.4) | 1.15 (0.4) |
Post-bronchodilator FEV1 (% predicted) | 37.1 (10.5) | 36.8 (9.9) | 36.8 (10.7) | 36.1 (9.7) | 37.3 (10.3) | 37.3 (9.9) |
Reversibility: | ||||||
Change in FEV1 (mL) | 126.9 (140.1) | 125.8 (149.1) | 165.6 (142.8) | 160.9 (150.0) | 98.1 (130.9) | 97.6 (142.4) |
Change in FEV1 (%) | 14.6 (16.4) | 14.4 (16.4) | 19.4 (17.1) | 19.1 (17.6) | 11.0 (14.8) | 10.6 (14.4) |
FEV1/FVC (%) | 41.8 (11.3) | 41.8 (10.7) | 43.3 (10.7) | 43.1 (10.1) | 40.6 (11.5) | 40.7 (11.2) |
COPD severity, n (%) | ||||||
Very severe COPD | 329 (24.8) | 345 (25.4) | 148 (26.1) | 169 (27.9) | 181 (23.8) | 176 (23.4) |
Severe COPD | 864 (65.1) | 909 (66.9) | 356 (62.8) | 399 (65.8) | 508 (66.8) | 510 (67.7) |
COPD history, n (%) | ||||||
Emphysema | 352 (26.5) | 413 (30.4) | 193 (34.0) | 234 (38.6) | 159 (20.9) | 179 (23.8) |
Chronic bronchitis ± emphysema | 817 (61.6) | 847 (62.3) | 374 (66.0) | 372 (61.4) | 443 (58.3) | 475 (63.1) |
Pre-study medication for COPD, n (%)* | 1273 (96) | 1291 (95) | 537 (95) | 557 (92) | 736 (97) | 734 (98) |
Inhaled short-acting β agonists | 729 (55) | 734 (54) | 315 (56) | 333 (55) | 414 (55) | 401 (53) |
Inhaled corticosteroids | 579 (44) | 588 (43) | 218 (38) | 225 (37) | 361 (48) | 363 (48) |
Inhaled short-acting anticholinergics | 549 (41) | 570 (42) | 189 (33) | 192 (32) | 360 (47) | 378 (50) |
Inhaled long-acting β2-agonists | 353 (27) | 379 (28) | 143 (25) | 140 (23) | 210 (28) | 239 (32) |
Xanthines | 320 (24) | 316 (23) | 113 (20) | 118 (20) | 207 (27) | 198 (26) |
Inhaled combination of β2-agonists and short-acting anticholinergics | 323 (24) | 314 (23) | 168 (30) | 174 (29) | 155 (20) | 140 (19) |
Inhaled combination of corticosteroids and long-acting β2-agonists | 260 (20) | 263 (19) | 131 (23) | 139 (23) | 129 (17) | 124 (17) |
Concomitant short-acting anticholinergics, n (%) | 786 (59) | 818 (60) | 334 (59) | 350 (58) | 452 (60) | 468 (62) |
Concomitant inhaled corticosteroids, n (%) | 809 (61) | 813 (60) | 328 (58) | 332 (55) | 481 (63) | 481 (64) |