TABLE 3

Pulmonary function tests results

Pulmonary function testPBI-4050 alonePBI-4050+nintedanibPBI-4050+pirfenidone
Patients n91615
FVC % pred
 Baseline
  Mean±sd83.11±17.3771.31±17.0570.80±14.82
  Median79.069.068.0
  Range58.0–109.045.0–107.045.0–100.0
 Week 12
  Mean±sd82.00±16.5771.38±15.9868.11±15.79
  Median74.069.564.0
  Range56.0–105.051.0–98.039.0–101.0
 Change from baseline at week 12
  Mean±sd−1.11±4.460.06±4.02−2.69±4.11
  Median−1.01.0−4.0
  95% CI−4.5–2.3−2.1–2.2−5.00–−0.4
  p-value#0.47590.95130.0240
FVC mL
 Baseline
  Mean±sd2884±759.592761±530.032849±745.62
  Median265027352930
  Range1750–43801290–34801580–4280
 Week 12
  Mean±sd2872±811.822763±520.702747±813.67
  Median277027752720
  Range1640–43301430–34401470–4360
 Change from baseline at week 12
  Mean±sd−12.2±137.11.9±127.6−102±137.8
  Median−50.025.0−140
  95% CI−117.6–93.2−66.1–69.9−178.3–−25.7
  p-value#0.79590.95390.0124
DLCO % pred
 Baseline
  Mean±sd45.22±11.6250.75±14.8149.07±16.33
  Median47.053.045.0
  Range27.0–64.024.0–70.023.0–83.0
 Week 12
  Mean±sd41.22±11.2049.25±14.0346.53±18.10
  Median41.049.545.0
  Range26.0–56.022.0–72.018.0–83.0
 Change from baseline at week 12
  Mean±sd−4.00±7.4−1.50±3.5−2.54±6.3
  Median−3.0−3.00.0
  95% CI−9.7–1.7−3.4–0.37−6.0–0.9
  p-value#0.14270.10730.1390

FVC: forced vital capacity; % pred: % predicted; DLCO: diffusing capacity of the lung for carbon monoxide. #: p-value based on paired t-test.