Roflumilast | Placebo | Effect size | |||||
---|---|---|---|---|---|---|---|
Characteristic | n | Rate | n | Rate | Rate ratio (SE) | Change (%) | p value |
M2-111 | 567 | 0.595 | 606 | 0.692 | 0.860 (0.085) | -14.0 | 0.129 |
M2-112 | 760 | 0.455 | 753 | 0.537 | 0.848 (0.081) | -15.2 | 0.085 |
Pooled results | |||||||
Overall | 1327 | 0.523 | 1359 | 0.610 | 0.857 (0.059) | -14.3 | 0.026 |
Sex | |||||||
Female | 369 | 0.612 | 385 | 0.648 | 0.943 (0.117) | -5.7 | 0.637 |
Male | 958 | 0.495 | 974 | 0.609 | 0.813 (0.071) | -18.7 | 0.018 |
Smoking status | |||||||
Current smoker | 529 | 0.529 | 530 | 0.643 | 0.823 (0.094) | -17.7 | 0.086 |
Former smoker | 798 | 0.568 | 829 | 0.663 | 0.857 (0.078) | -14.3 | 0.092 |
Concomitant treatment | |||||||
ICS | 809 | 0.720 | 813 | 0.886 | 0.812 (0.068) | -18.8 | 0.014 |
No ICS | 518 | 0.424 | 546 | 0.460 | 0.923 (0.124) | -7.7 | 0.550 |
Concomitant treatment | |||||||
Short-acting anticholinergics | 786 | 0.706 | 818 | 0.864 | 0.817 (0.066) | -18.3 | 0.012 |
No short-acting anticholinergics | 541 | 0.368 | 541 | 0.370 | 0.995 (0.147) | -0.5 | 0.974 |
COPD severity | |||||||
Very severe COPD | 329 | 0.738 | 345 | 0.885 | 0.833 (0.101) | -16.7 | 0.132 |
Severe COPD | 864 | 0.526 | 909 | 0.609 | 0.864 (0.080) | -13.6 | 0.113 |
COPD history | |||||||
Emphysema | 352 | 0.579 | 413 | 0.586 | 0.989 (0.120) | -1.1 | 0.925 |
Chronic bronchitis ± emphysema | 817 | 0.486 | 847 | 0.659 | 0.738 (0.068) | -26.2 | 0.001 |
Chronic bronchitis ± emphysema with concomitant ICS | 492 | 0.608 | 493 | 0.871 | 0.698 (0.077) | -30.2 | 0.001 |
Chronic bronchitis ± emphysema: no ICS | 325 | 0.391 | 354 | 0.462 | 0.845 (0.140) | -15.5 | 0.310 |
Cough score at Week 0 | |||||||
≥ 1 (average/day) | 896 | 0.560 | 939 | 0.708 | 0.791 (0.067) | -20.9 | 0.006 |
< 1 (average/day) | 395 | 0.523 | 385 | 0.508 | 1.030 (0.142) | 3.0 | 0.830 |
Sputum score at Week 0 | |||||||
≥ 1 (average/day) | 829 | 0.576 | 862 | 0.700 | 0.822 (0.074) | -17.8 | 0.030 |
< 1 (average/day) | 458 | 0.512 | 460 | 0.549 | 0.933 (0.113) | -6.7 | 0.565 |
Study completion status | |||||||
Completers | 894 | 0.453 | 1011 | 0.573 | 0.790 (0.064) | -21 | 0.004 |
Non-completers | 433 | 1.126 | 348 | 1.155 | 0.975 (0.113) | -2.5 | 0.826 |