Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
Conditions
Brief summary
Absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52
Detailed description
Key secondary endpoint: Time to the first occurrence of any of the components of the composite endpoint: time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial, Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the duration of trial, Time to hospitalization for respiratory cause or death over the duration of trial, Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial, Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial, Time to death over the duration of trial, Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52, Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52, Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52, Absolute change from baseline in FVC % predicted at Week 52, Absolute change from baseline in DLCO % predicted at Week 52
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint: Time to the first occurrence of any of the components of the composite endpoint: time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial, Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the duration of trial, Time to hospitalization for respiratory cause or death over the duration of trial, Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial, Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial, Time to death over the duration of trial, Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52, Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52, Absol | — |
Countries
Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden