Progressive Pulmonary Fibrosis
Conditions
Brief summary
The main trial endpoint is the change from baseline in FVC, the maximum amount of air that can be exhaled when blowing out as fast as possible (measured in milliliters) at Week 52
Detailed description
Change from Baseline in QoL measurements as assessed by Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) total score at Week 52, Time to disease progression. Disease progression is defined as absolute FVC percent predicted decline of ≥10% through Week 52 or all-cause death, Change in lung fibrosis score based on high-resolution computed tomography (HRCT) from Baseline to 52 weeks
Interventions
DRUGPlacebo for AP01
Sponsors
Avalyn Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main trial endpoint is the change from baseline in FVC, the maximum amount of air that can be exhaled when blowing out as fast as possible (measured in milliliters) at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in QoL measurements as assessed by Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) total score at Week 52, Time to disease progression. Disease progression is defined as absolute FVC percent predicted decline of ≥10% through Week 52 or all-cause death, Change in lung fibrosis score based on high-resolution computed tomography (HRCT) from Baseline to 52 weeks | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed