Progressive pulmonary fibrosis [PPF] Idiopathic pulmonary fibrosis [IPF]
Conditions
Brief summary
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), Incidence of adverse events of special interest (AESIs), Incidence of treatment-emergent all-cause deaths, Incidence of treatment-emergent respiratory deaths, Incidence of exacerbation of pulmonary fibrosis, Changes from baseline in clinical laboratory tests and vital signs
Detailed description
Change from baseline in forced vital capacity (FVC) (mL) at intervals of 6 months, Annual rate of decline in FVC (mL)
Interventions
Sponsors
Avalyn Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), Incidence of adverse events of special interest (AESIs), Incidence of treatment-emergent all-cause deaths, Incidence of treatment-emergent respiratory deaths, Incidence of exacerbation of pulmonary fibrosis, Changes from baseline in clinical laboratory tests and vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in forced vital capacity (FVC) (mL) at intervals of 6 months, Annual rate of decline in FVC (mL) | — |
Countries
Czechia, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed