TABLE 3.
Pulmonary function test | PBI-4050 alone | PBI-4050+nintedanib | PBI-4050+pirfenidone |
Patients n | 9 | 16 | 15 |
FVC % pred | |||
Baseline | |||
Mean±sd | 83.11±17.37 | 71.31±17.05 | 70.80±14.82 |
Median | 79.0 | 69.0 | 68.0 |
Range | 58.0–109.0 | 45.0–107.0 | 45.0–100.0 |
Week 12 | |||
Mean±sd | 82.00±16.57 | 71.38±15.98 | 68.11±15.79 |
Median | 74.0 | 69.5 | 64.0 |
Range | 56.0–105.0 | 51.0–98.0 | 39.0–101.0 |
Change from baseline at week 12 | |||
Mean±sd | −1.11±4.46 | 0.06±4.02 | −2.69±4.11 |
Median | −1.0 | 1.0 | −4.0 |
95% CI | −4.5–2.3 | −2.1–2.2 | −5.00–−0.4 |
p-value# | 0.4759 | 0.9513 | 0.0240 |
FVC mL | |||
Baseline | |||
Mean±sd | 2884±759.59 | 2761±530.03 | 2849±745.62 |
Median | 2650 | 2735 | 2930 |
Range | 1750–4380 | 1290–3480 | 1580–4280 |
Week 12 | |||
Mean±sd | 2872±811.82 | 2763±520.70 | 2747±813.67 |
Median | 2770 | 2775 | 2720 |
Range | 1640–4330 | 1430–3440 | 1470–4360 |
Change from baseline at week 12 | |||
Mean±sd | −12.2±137.1 | 1.9±127.6 | −102±137.8 |
Median | −50.0 | 25.0 | −140 |
95% CI | −117.6–93.2 | −66.1–69.9 | −178.3–−25.7 |
p-value# | 0.7959 | 0.9539 | 0.0124 |
DLCO % pred | |||
Baseline | |||
Mean±sd | 45.22±11.62 | 50.75±14.81 | 49.07±16.33 |
Median | 47.0 | 53.0 | 45.0 |
Range | 27.0–64.0 | 24.0–70.0 | 23.0–83.0 |
Week 12 | |||
Mean±sd | 41.22±11.20 | 49.25±14.03 | 46.53±18.10 |
Median | 41.0 | 49.5 | 45.0 |
Range | 26.0–56.0 | 22.0–72.0 | 18.0–83.0 |
Change from baseline at week 12 | |||
Mean±sd | −4.00±7.4 | −1.50±3.5 | −2.54±6.3 |
Median | −3.0 | −3.0 | 0.0 |
95% CI | −9.7–1.7 | −3.4–0.37 | −6.0–0.9 |
p-value# | 0.1427 | 0.1073 | 0.1390 |
FVC: forced vital capacity; % pred: % predicted; DLCO: diffusing capacity of the lung for carbon monoxide. #: p-value based on paired t-test.