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Table 1 Disease severity and definition of progression used in eligibility criteria for selected recently completed and ongoing clinical trials evaluating PF-ILD

From: Progression of fibrosing interstitial lung disease

Clinical trialDisease severityMinimum definition of progression
Pulmonary functionHRCTTime framePulmonary functionSymptomsHRCT
Pirfenidone in unclassifiable ILD [15]FVC ≥ 45%
DLCO ≥30%
6MWD ≥ 150 m
Fibrosis affecting > 10% of lung volume6 monthsFVC > 5% decline (absolute)Worsening symptoms 
Pirfenidone in progressive non-IPF ILD (RELIEF) [23]FVC 40–90%
DLCO 25–75%
6MWD ≥ 150 m
 12 monthsaFVC ≥ 5% decline (absolute) 
Nintedanib in non-IPF PF-ILD (INBUILD) [14]FVC ≥ 45%
DLCO 30–80%
Fibrosis affecting > 10% of lung volume24 monthsFVC ≥ 10% decline (relative)  
At least two of:
FVC 5–10% decline (relative)Worsening symptomsIncreasing extent of fibrosis
Pirfenidone in Patients With RA-ILD (TRAIL1) [24]FVC ≥ 40%
DLCO ≥30%
Fibrosis affecting > 10% of lung volume12 monthsFVC ≥ 10% decline (relative)
or
FVC 5–10% decline (relative) and
DLCO ≥15% decline (relative)
  
  1. Abbreviations: DLCO diffusing capacity of the lungs for carbon monoxide, FVC forced vital capacity, HRCT high-resolution computed tomography, ILD interstitial lung disease, IPF idiopathic pulmonary fibrosis, PF-ILD progressive fibrosing ILD, RA rheumatoid arthritis, 6MWD 6-min walk distance
  2. a≥3 pulmonary function tests within 6–24 months, extrapolated to 12 months