Table 3 Prespecified endpoints of the I-FILE study
Primary endpoint |
 Absolute FVC change measured with home spirometry from baseline to 6, 12 and 24 months (in % and L) |
Secondary endpoints |
 Absolute FVC change measured with in-hospital spirometry between baseline and 6, 12 and 24 months (in % and L)  Absolute DLCO change measured with in-hospital spirometry between baseline and 6, 12 and 24 months (in % and L)  Change in oxygen saturation from baseline to 6, 12 and 24 months (in %)  Correlations between home and hospital spirometry  Adherence to daily and weekly home spirometry  HRQOL and symptom changes between baseline, 6, 12 and 24 months  Time to change in HRQOL  Correlations between pulmonary function tests and PROMs at all time points  Internal consistency, discriminative ability, concurrent validity, and responsiveness of PROMs in individual diseases  Hospitalizations (all cause and respiratory related)  Mortality  Percentage of patients with disease progression  Identification of markers for disease progression or death  Percentage of patients with new oxygen prescription  Differences in outcomes between countries  Differences in outcomes between subgroups of PF  Healthcare provider and patient satisfaction and experience with the online application |