Characteristics | Full analysis set | Per-protocol analysis set | ||||||
---|---|---|---|---|---|---|---|---|
Trial n=175 | Control n=175 | t/χ 2 /Z | P | Trial n=155 | Control n=151 | t/χ 2 /Z | P | |
Age (years) | 66.33 ± 9.63 | 64.28 ± 9.42 | −0.935 | 0.351 | 62.74 ± 9.87 | 64.66 ± 8.92 | −1.778 | 0.076 |
Course of disease△ | 169.56 ± 290.63 | 161.07 ± 128.45 | 0.353 | 0.725 | 166.86 ± 305.92 | 163.18 ± 131.84 | 0.136 | 0.892 |
BMI▲ | 24.26 ± 11.79 | 23.75 ± 3.10 | 0.543 | 0.587 | 24.41 ± 12.54 | 23.74 ± 3.09 | 0.643 | 0.521 |
Exacerbationâ–¡ | ||||||||
Frequency (times) | 3.26 ± 2.27 | 2.94 ± 2.05 | 1.378 | 0.169 | 3.32 ± 2.31 | 2.95 ± 1.91 | 1.523 | 0.129 |
Duration (days) | 2.78 ± 2.00 | 2.73 ± 1.97 | 0.228 | 0.820 | 2.82 ± 2.08 | 2.75 ± 1.81 | 0.319 | 0.750 |
Lung functionâ– | ||||||||
FVC (liters) | 2.91 ± 0.95 | 2.81 ± 0.89 | 0.953 | 0.341 | 2.95 ± 0.97 | 2.81 ± 0.92 | 1.239 | 0.216 |
FEV1(liters) | 1.46 ± 0.57 | 1.35 ± 0.46 | 1.465 | 0.144 | 1.46 ± 0.57 | 1.35 ± 0.46 | 1.747 | 0.082 |
FEV1% | 49.89 ± 10.84 | 49.58 ± 12.07 | 0.244 | 0.807 | 49.94 ± 10.95 | 49.58 ± 12.36 | 0.266 | 0.790 |
Gender | ||||||||
Male | 122 | 131 | 1.556 | 0.212 | 106 | 116 | 2.732 | 0.098 |
Female | 54 | 43 | 49 | 35 | ||||
Smoking status | ||||||||
Currently smoking | 103 | 114 | 1.817 | 0.178 | 89 | 102 | 3.346 | 0.067 |
None-smoking | 73 | 60 | 66 | 49 | ||||
Smoking pack-years | 380.91 ± 158.26 | 366.47 ± 150.32 | 0.686 | 0.493 | 377.08 ± 164.08 | 372.47 ± 154.47 | 0.199 | 0.843 |
GOLD classification | ||||||||
GOLD 1 | 14 | 6 | −0.093 | 0.926 | 13 | 6 | −0.369 | 0.712 |
GOLD 2 | 68 | 80 | 61 | 66 | ||||
GOLD 3 | 94 | 88 | 81 | 79 |