TABLE 1

Demographics and baseline characteristics

ASCEND (study 016)CAPACITY (study 004)CAPACITY (study 006)Pooled population
PirfenidonePlaceboPirfenidonePlaceboPirfenidonePlaceboPirfenidonePlacebo
Subjects n278277174174171173623624
Age years69.0
(47–80)
68.0
(41–80)
66.0
(45–80)
67.0
(40–79)
67.0
(45–80)
68.0
(42–80)
68.0
(45–80)
68.0
(40–80)
Male79.976.967.873.671.971.774.374.5
Caucasian91.790.696.696.698.898.895.094.6
FVC % predicted68.1
(48–91)
68.0
(49–91)
73.0
(52–124)
73.6
(48–136)
74.5
(50–108)
70.3
(52–128)
71.1
(48–124)
70.3
(48–136)
DLCO % predicted41.5
(27–78)
43.0
(27–170)
45.4
(30–81)
43.7
(30–90)
45.6
(31–81)
46.2
(33–78)
44.0
(27–81)
44.1
(27–170)
6MWD m409.3
(176–731)
423.0
(163–716)
421.0
(145–692)
415.5
(178–637)
381.0
(112–616)
395.5
(171–660)
400.0
(112–731)
413.5
(163–716)
UCSD SOBQ score30.5
(0–95)
35.0
(0–96)
29.0
(0–94)
27.0
(0–81)
33.0
(1–100)
32.0
(1–105)
31.0
(0–100)
31.5
(0–105)
FEV1/FVC ratio0.84
(0.72–0.99)
0.84
(0.76–0.94)
0.84
(0.69–0.96)
0.84
(0.70–0.97)
0.84
(0.70–0.97)
0.83
(0.69–0.94)
0.84
(0.69–0.99)
0.84
(0.69–0.97)
Supplemental O2 use28.127.416.714.428.128.324.924.0
HRCT “Definite IPF”95.794.691.494.387.691.392.393.6
Time since diagnosis years1.4
(>0–5)
1.4
(>0–4)
1.0
(>0–4)
1.1
(>0–4)
0.7
(>0–4)
0.7
(>0–4)
1.1
(>0–5)
1.1
(>0–4)
  • Data presented as median (range) or %, unless otherwise stated. FVC: forced vital capacity; DLCO: diffusing capacity of the lung for carbon monoxide; 6MWD: 6-min walk distance; UCSD SOBQ: University of California San Diego Shortness of Breath Questionnaire; FEV1: forced expiratory volume in 1 s; HRCT: high-resolution computed tomography; IPF: idiopathic pulmonary fibrosis.