|
Parameter
|
All patients
|
Pirfenidone
|
Placebo
|
|---|
|
(n = 267)
|
(n = 163)
|
(n = 104)
|
|---|
|
Gender
| | | |
|
Male, n (%)
|
213 (79.8%)
|
132 (81.0%)
|
81 (77.9%)
|
|
Female, n (%)
|
54 (20.2%)
|
31 (19.0%)
|
23 (22.1%)
|
|
Age, year
|
64.8 (6.9)
|
64.9 (6.7)
|
64.7 (7.3)
|
| |
(n = 267)
|
(n = 163)
|
(n = 104)
|
|
BMI
|
24.3 (3.0)
|
24.1 (2.9)
|
24.6 (3.2)
|
| |
(n = 267)
|
(n = 163)
|
(n = 104)
|
|
Smoking
| | | |
|
Current and former, n (%)
|
212 (79.4%)
|
129 (79.1%)
|
83 (79.8%)
|
|
Never, n (%)
|
55 (20.6%)
|
34 (20.9%)
|
21 (20.2%)
|
|
Dyspnea scale (modified by Fletcher)
|
|
1, n (%)
|
53 (19.9%)
|
33 (20.2%)
|
20 (19.2%)
|
|
2, n (%)
|
143 (53.6%)
|
80 (49.1%)
|
63 (60.6%)
|
|
3, n (%)
|
71 (26.6%)
|
50 (30.7%)
|
21 (20.2%)
|
|
4 and 5, n (%)
|
0 (0.0%)
|
0 (0.0%)
|
0 (0.0%)
|
|
PaO2, Torr
|
80.7 (9.6)
|
80.5 (9.6)
|
81.0 (9.5)
|
| |
(n = 265)
|
(n = 161)
|
(n = 104)
|
|
AaDO2, Torr
|
17.7 (10.3)
|
17.9 (10.7)
|
17.4 (9.7)
|
| |
(n = 265)
|
(n = 161)
|
(n = 104)
|
|
Lowest SpO2 during a 6MET, %
|
89.0 (2.2)
|
89.0 (2.3)
|
89.0 (2.0)
|
| |
(n = 266)
|
(n = 162)
|
(n = 104)
|
|
VC, L
|
2.44 (0.67)
|
2.41 (0.65)
|
2.47 (0.70)
|
| |
(n = 265)
|
(n = 161)
|
(n = 104)
|
|
%VC, %
|
77.8 (17.4)
|
76.9 (17.4)
|
79.1 (17.4)
|
| |
(n = 265)
|
(n = 161)
|
(n = 104)
|
|
%DLCO, %
|
53.6 (17.8)
|
52.6 (17.6)
|
55.2 (18.2)
|
| |
(n = 264)
|
(n = 161)
|
(n = 103)
|
|
Serum SP-D, ng/mL
|
238.8 (156.8)
|
231.6 (140.8)
|
250.1 (179.1)
|
| |
(n = 267)
|
(n = 163)
|
(n = 104)
|
|
Serum SP-A, ng/mL
|
93.2 (51.6)
|
92.5 (43.8)
|
94.3 (62.0)
|
| |
(n = 267)
|
(n = 163)
|
(n = 104)
|
|
Serum KL-6, U/mL
|
1317.0 (800.3)
|
1318.2 (803.1)
|
1315.0 (799.6)
|
| |
(n = 267)
|
(n = 163)
|
(n = 104)
|
- Data are presented as n (%), or mean (SD)
- BMI body mass index, PaO2 partial pressure of oxygen in arterial blood, AaDO2 alveolar–arterial oxygen difference, SpO2 peripheral capillary oxygen saturation, 6MET 6-min steady-state exercise test, VC vital capacity, DLCO diffusion capacity of the lung for carbon monoxide, SP surfactant protein, KL Krebs von den Lungen
