Table 2.
Baseline characteristics of the patients.
| Characteristics | Trial group (n = 55) | Control group (n = 59) | total (n = 114) | Group comparison | |
|---|---|---|---|---|---|
| t/χ2/z | p | ||||
| Age (year) | 70.65 ± 8.07 | 67.78 ± 8.59 | 69.17 ± 8.43 | t = 1.84 | 0.069 |
| Gender | χ2 = 0.18 | 0.675 | |||
| Male n (%) | 44 (80.00) | 49 (83.05) | 93 (81.58) | ||
| Female n (%) | 11 (20.00) | 10 (16.95) | 21 (18.42) | ||
| BMI※ | 23.01 ± 3.03 | 22.81 ± 3.38 | 22.91 ± 3.20 | t = 0.33 | 0.743 |
| Smoking status | χ2 = 0.118 | 0.731 | |||
| Not smoking n (%) | 26 (47.27) | 26 (44.07) | 52 (45.61) | ||
| Currently smoking n (%) | 29 (52.73) | 33 (55.93) | 62 (54.39) | ||
| Symptoms | |||||
| Shortness of breath | 4.47 ± 1.90 | 4.17 ± 1.67 | 4.32 ± 1.79 | t = 0.90 | 0.368 |
| Cough | 2.44 ± 1.13 | 2.17 ± 0.85 | 2.30 ± 1.00 | t = 1.41 | 0.161 |
| Sputum | 2.33 ± 1.20 | 2.34 ± 0.99 | 2.33 ± 1.09 | t = 0.06 | 0.955 |
| Acute attack | |||||
| Frequency (times) | 1.00 (0.00,7.00) | 1.00 (0.00, 9.00) | 1.00 (0.00, 9.00) | Z = 0.318 | 0.751 |
| Hospitalization □ | |||||
| Frequency (times) | 1.00 (0.00, 4.00) | 0.00 (0.00, 9.00) | 1.00 (0.00, 9.00) | Z = 1.079 | 0.281 |
| Duration (day) | 10.00 (0.00, 65.00) | 0.00 (0.00, 63.00) | 9.00 (0.00, 65.00) | Z = 0.969 | 0.333 |
| Lung function | |||||
| FVC | 2.09 ± 0.64 | 2.40 ± 0.80 | 2.25 ± 0.74 | t = 2.25 | 0.026 |
| FVC% | 64.46 ± 15.08 | 68.37 ± 17.66 | 66.48 ± 16.51 | t = 1.27 | 0.208 |
| FEV1 | 1.07 ± 0.34 | 1.31 ± 0.53 | 1.20 ± 0.46 | t = 2.91 | 0.004 |
| FEV1% | 43.94 ± 13.51 | 47.52 ± 15.90 | 45.79 ± 14.84 | t = 1.29 | 0.200 |
| FEV1/FVC | 52.34 ± 10.25 | 54.65 ± 10.63 | 53.54 ± 10.47 | t = 1.18 | 0.240 |
| CAT | 16.36 ± 6.01 | 15.58 ± 5.83 | 15.96 ± 5.91 | t = 0.71 | 0.480 |
| 6MWT | 365.89 ± 115.81 | 373.14 ± 116.81 | 369.64 ± 115.87 | t = 0.33 | 0.740 |
| mMRC | Z = 0.969 | 0.333 | |||
| 0 n (%) | 3 (5.45) | 4 (6.78) | 7 (6.14) | ||
| 1 n (%) | 14 (25.45) | 23 (38.98) | 37 (32.46) | ||
| 2 n (%) | 30 (54.55) | 18 (30.51) | 48 (42.11) | ||
| 3 n (%) | 8 (14.55) | 13 (22.03) | 21 (18.42) | ||
| 4 n (%) | 0 (0.00) | 1 (1.69) | 1 (0.88) | ||
※BMI = weight (Kg)/height2(m). □Hospitalizations within the 12-month period before screening were self-reported.