Table 1.
Demographics and baseline clinical characteristics of mITT population by study cohort
| Parameter | Treamid (n = 29) | Placebo (n = 30) | p-valuea | Overall (n = 59) |
|---|---|---|---|---|
| Age (year) | 54 ± 10 | 56 ± 12 | 0.526 (t) | 55 ± 11 |
| Male, n (%) | 10 (34.5) | 16 (53.3) | 0.145 (c) | 26 (44.1) |
| BMI (kg/m2) | 28.5 ± 4.9 | 27.8 ± 4.5 | 0.584 (t) | 28.1 ± 4.7 |
| 6MWD (m) | 423.6 ± 80.2 | 418.9 ± 96.7 | 0.844 (t) | 421.3 ± 87.9 |
| 6MWD (%, predicted)1 | 78.3 ± 14.8 | 76 ± 18.6 | 0.609 (t) | 77.2 ± 16.6 |
| Borg scale (score) | 2.2 ± 0.8 | 1.8 ± 1.1 | 0.183 (t) | 2.0 ± 1.0 |
| mMRC scale (score) | 2.0 ± 0.0 | 2.1 ± 0.3 | 0.168 (u) | 2.0 ± 0.2 |
| KBILD questionnaire (score) | 50.2 ± 4.5 | 52.8 ± 6.7 | 0.089 (t) | 51.5 ± 5.8 |
| Pulmonary function | ||||
| FEV1 (l) | 2.7 ± 0.7 | 2.9 ± 0.8 | 0.235 (t) | 2.8 ± 0.7 |
| FVC (l) | 3.3 ± 0.8 | 3.5 ± 0.9 | 0.330 (t) | 3.4 ± 0.8 |
| FEV1/FVC, % | 80.1 ± 11.0 | 82.1 ± 9.8 | 0.466 (t) | 81.1 ± 10.3 |
| TLC (l) | 5.6 ± 1.4 | 6.0 ± 1.2 | 0.223 (t) | 5.8 ± 1.3 |
| FRC (l) | 3.1 ± 0.9 | 3.4 ± 1.1 | 0.481 (u) | 3.3 ± 1.0 |
| DLCO (mmol/min/kPa) | 19.9 ± 5.1 | 20.3 ± 5.5 | 0.822 (t) | 20.1 ± 5.2 |
| Pulmonary function (%, predicted) | ||||
| FEV1 | 87.5 ± 17.8 | 91.1 ± 17.0 | 0.439 (t) | 89.3 ± 17.3 |
| FVC | 86.0 ± 14.0 | 87.4 ± 16.3 | 0.932 (u) | 86.7 ± 15.1 |
| TLC | 96.6 ± 13.8 | 98.5 ± 14.9 | 0.596 (u) | 97.6 ± 14.2 |
| FRC | 100.8 ± 21.9 | 108.6 ± 34.7 | 0.601 (u) | 104.8 ± 29.1 |
| DLCO | 73.9 ± 15.7 | 73.7 ± 14.1 | 0.559 (u) | 73.8 ± 14.8 |
| Lung damage, % | 27.9 ± 20.7 | 29.6 ± 21.5 | 0.757 (t) | 28.7 ± 20.9 |
| CT score | ||||
| 1 | 17 (58.6) | 15 (50.0) | 0.506 (c) | 32 (54.2) |
| 2 | 9 (31.0) | 12 (40.0) | 0.472 (c) | 21 (35.6) |
| 3 | 3 (10.3) | 3 (10.0) | 1.000 (f) | 6 (10.2) |
Data are mean ± SD or n (%). Baseline defined as the mean assessments at screening (or at randomization for 6MWD, modified Borg scale, mMRC scale and KBILD)
6MWD distance walked in 6 min walk test, BMI body mass index, CT computed tomography, DLCO diffusing capacity of the lungs for carbon monoxide, adjusted for blood hemoglobin concentration; FEV1 forced expiratory volume in 1 s, FRC functional residual capacity, FVC forced vital capacity; K-BILD King’s brief interstitial lung disease questionnaire, mMRC modified Medical Research Council dyspnea scale; TLC total lung capacity
1Calculated according the formula 7.57 × Height − 5.02 × Age − 1.76 × mass − 309 (for men) and 2.11 × Height − 5.78 × Age − 2.29 × mass + 667 (for women) [33]
aTest is put in brackets: c—Chi-squared test, f—Fisher's exact test, t—Student's t-test, u—Mann–Whitney test