TABLE 1

Baseline demographic and clinical characteristics

 Baseline FVC ≥80%Baseline FVC <80%Baseline GAP stage IBaseline GAP stage II–III
PirfenidonePlaceboPirfenidonePlaceboPirfenidonePlaceboPirfenidonePlacebo
Patients146170477454247235376387
Age years68.5±7.168.7±7.366.8±7.766.6±7.562.5±7.862.6±8.070.3±5.669.9±5.7
Male102 (69.9)122 (71.8)361 (75.7)343 (75.6)136 (55.1)135 (57.4)327 (87.0)328 (84.8)
White136 (93.2)160 (94.1)456 (95.6)430 (94.7)231 (93.5)222 (94.5)361 (96.0)366 (94.6)
BMI kg·m−229.4±4.229.4±4.330.0±4.529.8±4.530.3±4.930.5±4.629.6±4.129.2±4.2
Smokers
 Never47 (32.2)52 (30.6)162 (34.0)171 (37.7)93 (37.7)89 (37.9)116 (30.9)133 (34.4)
 Ex94 (64.4)109 (64.1)312 (65.4)275 (60.6)147 (59.5)136 (57.9)259 (68.9)247 (63.8)
 Current5 (3.4)9 (5.3)3 (0.6)8 (1.8)7 (2.8)10 (4.3)1 (0.3)7 (1.8)
Supplemental O2 use20 (13.7)27 (15.9)135 (28.3)123 (27.1)54 (21.9)48 (20.4)101 (26.9)102 (26.4)
FVC % pred89.5±9.289.6±9.266.2±8.665.4±8.076.9±13.977.8±14.368.1±11.568.3±11.6
DLCO %51.0±10.550.3±11.343.9±9.543.8±10.551.2±10.451.5±10.441.8±8.142.0±10.0
FEV1/FVC ratio0.82±0.050.81±0.050.84±0.040.84±0.040.84±0.050.83±0.050.84±0.040.83±0.05
UCSD SOBQ score29.0±21.832.2±21.635.8±21.035.9±21.531.3±22.332.9±21.336.1±20.636.3±21.7
6MWD m413.8±94.5423.4±88.1400.8±93.3407.5±96.1415.1±94.5429.4±92.2396.4±92.6401.7±93.7
HRCT diagnosis
 Definite UIP134 (92.4)163 (95.9)440 (92.2)421 (92.7)216 (87.4)215 (91.5)358 (95.5)367 (94.8)
 Probable/possible UIP9 (6.2)7 (4.1)37 (7.8)33 (7.3)29 (11.7)20 (8.5)17 (4.5)20 (5.2)
SLB diagnosis
 Definite UIP55 (90.2)59 (90.8)174 (84.9)161 (83.4)114 (87.7)102 (84.3)115 (84.6)116 (85.9)
 Probable/possible UIP6 (9.8)6 (9.2)29 (14.1)30 (15.5)14 (10.8)18 (14.9)21 (15.4)18 (13.3)
Time from IPF diagnosis to randomisation years1.4±1.11.4±1.11.5±1.11.5±1.11.3±1.01.3±1.11.5±1.11.6±1.1
  • Data are presented as n, mean±sd or n (%). FVC: forced vital capacity; GAP: gender, age and physiology index; BMI: body mass index; DLCO: diffusing capacity of the lung for carbon monoxide; FEV1: forced expiratory volume in 1 s; 6MWD: 6-min walking distance; UCSD SOBQ: University of California San Diego Shortness of Breath Questionnaire; HRCT: high-resolution computed tomography; UIP: usual interstitial pneumonia; SLB: surgical lung biopsy; IPF: idiopathic pulmonary fibrosis.