Table 2.
Change from baseline to weeks 2 and 4 of parameters in mITT population (М ± SD or n (%))
| Parameter | Change from baseline to week 2 | p-valuea | Change from baseline to week 4 | p-valuea | ||
|---|---|---|---|---|---|---|
| Treamid | Placebo | Treamid | Placebo | |||
| 6MWD (m) | 39.8 ± 54.2 | 38.0 ± 40.7 | 0.98 (u) | 78.6 ± 75.2 | 71.8 ± 50.2 | 0.960 (u) |
| 6MWD (%, predicted)a | 10.6 ± 14.0 | 11.0 ± 13.5 | 0.822 (u) | 21.3 ± 23.1 | 19.7 ± 16.5 | 0.720 (u) |
| Borg scale (score) | − 0.5 ± 0.9 | − 0.4 ± 0.8 | 0.411 (u) | − 0.9 ± 0.7 | − 0.4 ± 0.8 | 0.018 (u) |
| mMRC scale (score) | − 0.6 ± 0.5 | − 0.6 ± 0.5 | 0.717 (u) | − 1.1 ± 0.5 | − 1.1 ± 0.6 | 0.683 (u) |
| KBILD questionnaire (total score) | 7.4 ± 5.2 | 5.7 ± 3.9 | 0.585 (u) | 13.8 ± 7.1 | 11.7 ± 10.0 | 0.117 (u) |
| Breathlessness and activities | 9.7 ± 8.7 | 8.7 ± 8.1 | 0.638 (u) | 17.4 ± 9.1 | 16.5 ± 13.4 | 0.383 (u) |
| Chest symptoms | 13.3 ± 11.7 | 10.7 ± 9.5 | 0.471 (u) | 22.1 ± 16.7 | 18.3 ± 14.3 | 0.134 (u) |
| Psychological symptoms | 8.8 ± 7.3 | 6.0 ± 7.6 | 0.387 (u) | 16.7 ± 9.7 | 13.1 ± 13.2 | 0.145 (u) |
| Pulmonary function | ||||||
| FEV1 (l) | 0.1 ± 0.2 | 0.1 ± 0.2 | 0.617 (u) | 0.1 ± 0.3 | 0.1 ± 0.3 | 0.678 (u) |
| FVC (l) | 0.1 ± 0.3 | 0.2 ± 0.4 | 0.755 (u) | 0.1 ± 0.3 | 0.1 ± 0.3 | 0.725 (u) |
| FEV1/FVC, % | 0.6 ± 6.8 | − 1.5 ± 5.9 | 0.466 (u) | 2.3 ± 13.8 | − 0.9 ± 4.5 | 0.936 (u) |
| TLC (l) | 0.3 ± 0.5 | 0.1 ± 0.7 | 0.149 (u) | 0.3 ± 0.4 | 0.3 ± 0.8 | 0.210 (u) |
| FRC (l) | 0.0 ± 0.4 | 0.0 ± 0.6 | 0.431 (u) | 0.1 ± 0.5 | 0.0 ± 0.7 | 0.604 (u) |
| DLCO (mmol/min/kPa) | 2.0 ± 2.7 | 1.7 ± 2.8 | 0.451 (u) | 2.0 ± 2.4 | 1.5 ± 2.4 | 0.493 (t) |
| Pulmonary function (%, predicted)a | ||||||
| FEV1 | 3.7 ± 9.0 | 4.8 ± 10.4 | 0.731 (u) | 6.1 ± 19.1 | 3.4 ± 8.7 | 1.000 (u) |
| FVC | 4.3 ± 9.6 | 7.0 ± 12.0 | 0.838 (u) | 4.0 ± 9.8 | 4.4 ± 8.8 | 0.805 (u) |
| TLC | 5.1 ± 11.3 | 2.0 ± 11.8 | 0.171 (u) | 6.6 ± 8.9 | 5.3 ± 12.8 | 0.255 (u) |
| FRC | 1.2 ± 12.0 | − 2.4 ± 15.0 | 0.216 (u) | 2.6 ± 16.4 | 0.6 ± 16.4 | 0.421 (u) |
| DLCO | 8.7 ± 11.9 | 10.7 ± 17.2 | 0.864 (u) | 10.4 ± 11.6 | 9.9 ± 14.1 | 0.575 (u) |
| Lung damage, % | − 14.0 ± 12.0 | − 14.3 ± 12.9 | 0.962 (u) | |||
| CT score | ||||||
| Increase or no change | 9 (31) | 10 (33) | ||||
| Decrease | 20 (69) | 20 (67) | 0.850 (c) | |||
Data are mean ± SD or n (%). For abbreviations see Table 1
aData are given in relation to baseline level. Data in bold indicates significant p-value (< 0.05)
aTest is put in brackets: c—Chi-squared test, t—Student’s t-test, u—Mann–Whitney test