Definition of disease progression in the main ongoing studies involving patients with progressive fibrosing interstitial lung diseases

Study name and registration numberPeriod considered to assess progressionCriteria[Ref.]
INBUILD, NCT0299917824 months prior to screeningRelative decline in FVC ≥10% predicted[3]
Relative decline in FVC ≥5–<10% predicted combined with increased extent of fibrosis on HRCT
Relative decline in FVC ≥5–<10% predicted combined with worsening of respiratory symptoms
Worsened respiratory symptoms and increased extent of fibrosis on HRCT only
uILD, NCT030991876 months prior to screening>5% absolute decline in FVC % predicted[22]
Significant symptomatic worsening not due to cardiac, pulmonary (except worsening of underlying uILD), vascular or other causes (as determined by the investigator)
RELIEF, DRKS000098226 months prior to inclusionSlope calculation of at least three values documenting an annualised decline in FVC % predicted of 5% (absolute) or more despite appropriate conventional therapy[23]

One criterion was sufficient for eligibility in each of the respective studies. uILD: unclassifiable interstitial lung disease; FVC: forced vital capacity; HRCT: high-resolution computed tomography.