Familial pulmonary fibrosis, Interstitial lung diseases, Pulmonary fibrosis
Conditions
Brief summary
Time to physiologic or radiologic worsening of ILA/ILD (defined as: relative decline in FVC % predicted of >10% from baseline; or absolute decline in DLCO % predicted >10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) >2% and total disease extent (TDE) >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring, from baseline) over the whole trial
Detailed description
Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104, Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104, Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104, Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104, Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial, Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial, Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial, Time to absolute increase in wRVS >2% and TDE >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring over 52 weeks and over the whole trial, Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to physiologic or radiologic worsening of ILA/ILD (defined as: relative decline in FVC % predicted of >10% from baseline; or absolute decline in DLCO % predicted >10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) >2% and total disease extent (TDE) >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring, from baseline) over the whole trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104, Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104, Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104, Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104, Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial, Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial, Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial, Time to absolute increase in wRVS >2% and TDE >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring over 52 weeks and over the whole trial, Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks | — |