Table 1– Baseline demographics and clinical characteristics
Macitentan 10 mgPlacebo
Subjects n11959
Male84 (70.6)37 (62.7)
Age years66 (37–84)64 (49–81)
65.1±7.8564.5±6.32
IPF medical status
 Duration of symptoms days786 (151–4348)771 (60–3180)
 Duration since SLB-confirmed diagnosis days213 (3–1870)114 (2–1440)
 Digital clubbing23 (19.3)8 (13.6)
Smoking
 Never-smoker47 (39.5)22 (37.3)
 Ex-smoker67 (56.3)37 (62.7)
 Current smoker5 (4.2)0 (0.0)
Location
 USA37 (31.1)18 (30.5)
 Non-USA82 (68.9)41 (69.5)
FVC L2.83 (1.24–5.42)2.74 (1.36–6.61)
2.88±0.832.79±0.78
FVC % pred76.1 (47.7–121.1)73.8 (54.0–126.4)
76.5±15.674.8±14.6
Corrected DLCO mmol·kPa−1·min−14.16 (2.37–8.75)4.13 (2.25–8.70)
4.55±1.494.35±1.32
Corrected DLCO % pred46.5 (26.3 to 90.7)#43.7 (30.7–76.1)
47.8±13.4#45.6±11.2
Oral corticosteroid use28 (23.5)15 (25.4)
 Daily dose mg prednisone equivalent10.4±3.4212.1±5.17
N-acetylcysteine use19 (16.0)13 (22.0)
 Daily dose mg600±0.0592±27.7
Blood oxygenation mmHg
PaO277.9±11.580.2±15.0
PA–aO221.2±10.8+19.6±11.3§
  • Data are presented as n (%), median (range) or mean±sd, unless otherwise stated. IPF: idiopathic pulmonary fibrosis; SLB: surgical lung biopsy; FCV: forced vital capacity; DLCO: diffusing capacity of the lung for carbon monoxide; % pred: % predicted; PaO2: arterial oxygen tension; PA–aO2: alveolar–arterial oxygen tension difference. #: n=115; : n=113; +: n=107; §: n=55.