Clinical endpoint | US-based study ZRHM-REXA-08-US* (n=77) | Japan-based study ZRHR-REXA-07-JP† (n=111) |
FEV1 (% predicted) | 0.53 (−2.09 to 3.00) | 1.91 (−0.14 to 3.97) |
FEV1/FVC | 0.00 (−0.02 to 0.02) | N/A |
MEF 25–75 (L/s) | −0.67 (−6.33 to 4.99) | N/A |
DLCO (mL/min/mm Hg) | 0.31 (−1.09 to 1.72) | N/A |
KCO (mmol/min/kPa/L) | 0.05 (−0.02 to 0.12) | N/A |
TLC (L) | 0.09 (−0.25 to 0.43) | N/A |
FRV (L) | −0.09 (−0.31 to 0.13) | N/A |
IC (L) | 0.21 (−0.08 to 0.51) | N/A |
VC (L) | 0.10 (0.00 to 0.21) | N/A |
*Without bronchodilator.
†With bronchodilator.
DLCO, diffusion capacity of lung for carbon monoxide; IC, inspiratory capacity; FEV1, forced expiratory volume in 1 s; FRV, functional residual volume; FVC, forced vital capacity; KCO, rate constant of carbon monoxide; MEF, mid expiratory flow; N/A, not conducted or reported by PMI; TLC, total lung capacity; VC, vital capacity.