Idiopathic pulmonary fibrosis
Conditions
Brief summary
Change from baseline to end of treatment epoch (26 weeks of treatment) in Forced Vital Capacity (FVC) expressed in percent predicted
Detailed description
Change from baseline to end of treatment epoch (26 weeks of treatment) in Forced Vital Capacity (FVC) expressed in mL, • Time to progression as defined by a composite endpoint including any of the following events: • Absolute reduction from baseline of ≥10% predicted in FVC • Nonelective hospitalization for respiratory events • Lung Transplant • Death, Number of participants with absolute decline of ≥10% predicted in FVC, Change from baseline to the end of treatment epoch (26 weeks of treatment) in DLCO absolute and percent predicted, Change from baseline to the end of treatment epoch (26 weeks of treatment) in 6-minute walk distance, Change from baseline to the end of treatment epoch (26 weeks of treatment) in scores from the L-IPF (Impacts and Symptoms Modules), K-BILD, Leicester cough, and R-Scale for PF questionnaires, Adverse Events, physical examinations, labs, ECGs, vital signs
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of treatment epoch (26 weeks of treatment) in Forced Vital Capacity (FVC) expressed in percent predicted | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to end of treatment epoch (26 weeks of treatment) in Forced Vital Capacity (FVC) expressed in mL, • Time to progression as defined by a composite endpoint including any of the following events: • Absolute reduction from baseline of ≥10% predicted in FVC • Nonelective hospitalization for respiratory events • Lung Transplant • Death, Number of participants with absolute decline of ≥10% predicted in FVC, Change from baseline to the end of treatment epoch (26 weeks of treatment) in DLCO absolute and percent predicted, Change from baseline to the end of treatment epoch (26 weeks of treatment) in 6-minute walk distance, Change from baseline to the end of treatment epoch (26 weeks of treatment) in scores from the L-IPF (Impacts and Symptoms Modules), K-BILD, Leicester cough, and R-Scale for PF questionnaires, Adverse Events, physical examinations, labs, ECGs, vital signs | — |
Countries
Czechia, Germany, Netherlands, Poland