Table 1.
Patient characteristics in the mITT population
| Characteristics | TIO (N=201) | FP/SAL (N=204) | Total (N=405) |
|---|---|---|---|
| Age | |||
| Mean ± SD | 68±7.12 | 68.6±6.93 | 68.3±7.02 |
| Age group (years), n (%) | |||
| 40–49 | 6 (3) | 3 (1) | 9 (2) |
| 50–59 | 14 (7) | 16 (8) | 30 (7) |
| 60–69 | 89 (44) | 83 (41) | 172 (42) |
| 70–79 | 88 (44) | 99 (49) | 187 (46) |
| ≥80 | 4 (2) | 3 (1) | 7 (2) |
| Sex, n (%) | |||
| Male | 193 (96) | 192 (94) | 385 (95) |
| History of smoking, n (%) | |||
| Current smoker | 81 (40) | 82 (40) | 163 (40) |
| Former smoker | 119 (59) | 122 (60) | 241 (60) |
| Total pack-years | |||
| Mean ± SD | 54.53±27.7 | 60.75±33.0 | 57.67±30.7 |
| Duration of COPD (years) | |||
| Mean ± SD | 3.7±3.9 | 3.7±4.4 | 3.7±4.2 |
| COPD type, n (%) | |||
| Chronic bronchitis | 26 (13) | 29 (14) | 55 (14) |
| Emphysema | 164 (82) | 169 (83) | 333 (82) |
| Mixed | 11 (5) | 6 (3) | 17 (4) |
| Asthma overlap (current), n (%) | |||
| Yes | 38 (19) | 41 (20) | 79 (20) |
| mMRC grade by investigator, n (%) | |||
| 1 | 142 (71) | 132 (65) | 274 (68) |
| 2 | 45 (22) | 60 (29) | 105 (26) |
| 3 | 14 (7) | 12 (6) | 26 (6) |
| 4 | 0 | 0 | 0 |
| FEV1/FVC (%)a | |||
| Mean ± SD | 51.4±11.4 | 52.6±11.1 | 52.0±11.3 |
| CAT total score at screening | |||
| Mean ± SD | 12±6 | 12±6 | 12±6 |
| CAT total score category, n (%) | |||
| ≤9 | 71 (35) | 70 (34) | 141 (35) |
| 10–15 | 76 (38) | 85 (42) | 161 (40) |
| ≥16 | 54 (27) | 49 (24) | 103 (25) |
| Predicted FEV1 (%)a | |||
| Mean ± SD | 57.8±13.7 | 59.5±13.0 | 58.7±13.3 |
| Number of exacerbations within 12 months, n (%) | |||
| 0 | 185 (92) | 192 (94) | 377 (93) |
| ≥1 | 16 (8) | 12 (6) | 28 (7) |
| GOLD patient group, n (%) | |||
| A | 59 (29) | 57 (28) | 116 (29) |
| B | 83 (41) | 100 (49) | 183 (45) |
| C | 12 (6) | 13 (6) | 25 (6) |
| D | 47 (23) | 34 (17) | 81 (20) |
Note:
a
Post bronchodilator.
Abbreviations: CAT, COPD Assessment Test; FP/SAL, fluticasone propionate/salmeterol; GOLD, Global initiative for chronic Obstructive Lung Disease 2011 criteria; mITT, modified intent-to-treat; mMRC, modified Medical Research Council; TIO, tiotropium.