Table 2 Changes in primary and secondary efficacy variables: days 28 and 56
Amount of change | |||
|---|---|---|---|
Parameter | Placebo (n = 16) | 40 mg PC-SOD (n = 17) | 80 mg PC-SOD (n = 17) |
Day 28 | |||
FVC, % | 2.068 ± 6.539 | -2.567 ± 12.175 | 2.927 ± 11.822 |
LDH, % | 0.0 ± 11.3 | -0.1 ± 22.1 | -12.4 ± 11.0* |
SP-A, % | -1.9 ± 20.8 | -10.9 ± 22.3 | -21.2 ± 16.9† |
SP-D, % | -5.1 ± 24.4 | -10.9 ± 31.5 | -8.6 ± 45.6 |
KL-6, % | -4.7 ± 14.4 | -7.3 ± 16.8 | -8.0 ± 18.5 |
Borg scale | -0.19 ± 0.77 | 0.26 ± 1.94 | 0.15 ± 1.41 |
Day 56 | |||
FVC, % | 1.127 ± 7.951 | -1.993 ± 13.517 | 0.606 ± 13.716 |
LDH, % | 1.5 ± 14.4 | 3.6 ± 24.8 | 2.4 ± 19.3 |
SP-A, % | 3.1 ± 18.1 | -1.3 ± 23.8 | 3.4 ± 19.9 |
SP-D, % | 7.6 ± 41.4 | -7.8 ± 35.5 | 10.9 ± 66.1 |
KL-6, % | -2.7 ± 17.9 | -2.8 ± 18.6 | -0.7 ± 21.1 |
Borg scale | -0.06 ± 1.08 | 0.06 ± 1.08 | 0.97 ± 2.24 |