Table 2.
Baseline patient demographics and baseline characteristics depending on clinically important improvements or disease stability at V5/LOCF
| Baseline demographics and characteristicsa | CII Yes (N = 397) | CII No (N = 220) | DS Yes (N = 322) | DS No (N = 289) | |
|---|---|---|---|---|---|
| Sex | Male, n (%) | 223 (56.2) | 116 (52.7) | 168 (52.2) | 169 (58.5) |
| Female, n (%) | 174 (43.8) | 104 (47.3) | 154 (47.8) | 120 (41.5) | |
| Age (year), mean ± SD | 66.6 ± 9.9 | 66.8 ± 9.4 | 67.5 ± 9.4* | 65.5 ± 9.7 | |
| BMI (kg/m2), mean ± SD | 27.1 ± 5.5 | 26.7 ± 5.5 | 27.2 ± 5.4 | 26.9 ± 5.5 | |
| Smoking status | Active smoker, n (%) | 148 (37.3)* | 88 (40.0) | 107 (33.2)* | 127 (43.9) |
| Former smoker, n (%) | 193 (48.6)* | 117 (53.2) | 171 (53.1)* | 137 (47.4) | |
| Non-smoker, n (%) | 56 (14.1)* | 15 (6.8) | 44 (13.7)* | 25 (8.7) | |
| Atopic patient, n (%) | 32 (8.1) | 16 (7.3) | 22 (6.9) | 26 (9.0) | |
| Asthma diagnosis before 40th year of age, n (%) | 32 (8.1) | 21 (9.5) | 28 (8.7) | 25 (8.7) | |
| Chronic bronchitis at first diagnosis, n (%) | 177 (44.8) | 113 (51.4) | 146 (45.6) | 145 (50.2) | |
| GOLD spirometry grade | GOLD II | 230 (57.9)* | 105 (47.9) | 173 (53.7) | 158 (54.9) |
| GOLD III | 167 (42.1)* | 114 (52.1) | 149 (46.3) | 130 (45.1) | |
| Rate of COPD exacerbations in the prior 12 months | Total, mean ± SD | 1.4 ± 0.8 | 1.4 ± 0.7 | 1.4 ± 0.8 | 1.4 ± 0.7 |
| Mild, mean ± SD | 0.4 ± 0.8 | 0.3 ± 0.7 | 0.4 ± 0.8 | 0.3 ± 0.6 | |
| Moderate, mean ± SD | 0.8 ± 0.8 | 0.8 ± 0.8 | 0.8 ± 0.7 | 0.9 ± 0.8 | |
| Severe, mean ± SD | 0.1 ± 0.3** | 0.1 ± 0.4 | 0.1 ± 0.3 | 0.1 ± 0.4 | |
| Total CAT score, mean ± SD | 22.3 ± 6.6*** | 20.1 ± 6.3 | 22.0 ± 6.2* | 20.7 ± 6.8 | |
| FEV1 (L), mean ± SD | 1.455 ± 0.497 | 1.395 ± 0.493 | 1.396 ± 0.493* | 1.476 ± 0.507 | |
| mMRC grading | Grade 0-I, n (%) | 109 (27.7) | 55 (25.0) | 82 (25.7) | 78 (27.1) |
| Grade II-IV, n (%) | 285 (72.3) | 165 (75.0) | 238 (74.4) | 210 (72.9) | |
| Peripheral blood eosinophil count (%), mean ± SD# | 3.0 ± 2.7 | 2.7 ± 1.7 | 2.9 ± 2.5 | 2.9 ± 2.2 | |
| Peripheral blood eosinophils (cells/µl), mean ± SD## | 236.2 ± 219.0 | 217.6 ± 152.7 | 235.8 ± 228.2 | 221.7 ± 159.8 | |
| Prior treatment | LAMA/LABA/ICSb, n (%) | 92 (23.2) | 66 (30.0) | 73 (22.7)** | 87 (30.1) |
| ICS/LABAb, n (%) | 74 (18.6) | 29 (13.2) | 68 (21.1)** | 35 (12.1) | |
| LAMA/LABAb, n (%) | 231 (58.2) | 125 (56.8) | 181 (56.2)** | 167 (57.8) | |
Group comparison p value (χ2-test or t test) *p < 0.05; **p < 0.01; ***p < 0.0001; #N = 123–124; ##N = 118
BMI body mass index, CAT COPD Assessment Test, CII clinically important improvement, COPD chronic obstructive pulmonary disease, DS disease stability, FEV1 forced expiratory volume in 1 s, GOLD Global initiative of chronic obstructive pulmonary disease, ICS inhaled corticosteroid, LABA long-acting β2-agonist, LAMA long-acting muscarinic receptor antagonist, mMRC modified Medical Research Council Dyspnea Scale, SD standard deviation
aNumber of missing values varied between the described patient demographics and characteristics
bFixed or free combination