Definition of disease progression in the main ongoing studies involving patients with progressive fibrosing interstitial lung diseases
| Study name and registration number | Period considered to assess progression | Criteria | [Ref.] |
| INBUILD, NCT02999178 | 24 months prior to screening | Relative 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, NCT03099187 | 6 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, DRKS00009822 | 6 months prior to inclusion | Slope 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.