Placebo | PRM-151 | ||||
1 mg·kg−1 | 5 mg·kg−1 | 10 mg·kg−1 | All doses | ||
Subjects | 6 | 5 | 5 | 4 | 14 |
FVC L | |||||
Baseline | 2.15±0.64 | 2.96±0.85 | 2.78±0.73 | 2.97±0.71 | 2.90±0.71 |
Day 57 change from baseline | −0.063±0.116 | 0.058±0.164 | 0.060±0.074 | 0.078±0.210 | 0.064±0.142 |
FVC % pred | |||||
Baseline | 63.2±16.7 | 82.4±15.5 | 80.0±7.8 | 72.8±14.3 | 78.8±12.5 |
Day 57 change from baseline | −1.5±3.3 | 2.4±4.6 | 2.8±3.0 | 1.8±5.3 | 2.4±4.0 |
DLCO % | |||||
Baseline | 35.2±8.4 | 41.2±10.5 | 52.8±9.8 | 46.0±7.2 | 46.7±10.1 |
Day 57 change from baseline | −2.3±2.1 | 0.2±3.3 | −4.0±6.8 | −1.5±3.8 | −1.8±4.9 |
FEV1 % | |||||
Baseline | 68.8±17.7 | 85.8±16.8 | 87.0±11.9 | 73.0±12.1 | 82.6±14.3 |
Day 57 change from baseline | −1.7±4.3 | 2.6±4.3 | 2.4±1.1 | 0.3±3.8 | 1.9±3.2 |
6MWD m | |||||
Baseline | 458±73 | 457±157 | 470±101 | 439±63 | 456±109 |
Day 57 change from baseline | −11±51 | −11±63 | 6±43 | 35±45 | 8±51 |
Data are presented as n or mean±sd. FVC: forced vital capacity; DLCO: diffusing capacity of the lung for carbon monoxide; FEV1: forced expiratory volume in 1 s.