idiopathic pulmonary fibrosis (IPF)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Trial participants >=40 years old at the time of signed informed consent. Diagnosis of IPF based on the 2022 ATS/ERS/JRS/ALAT Guideline On stable treatment with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening or not on treatment with either nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening. Forced Vital Capacity (FVC) >=45% of predicted normal at Visit 1. DLCO >=25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.
Exclusion criteria
Exclusion criteria: Pre-bronchodilator FEV1/FVC 15 mg/day or equivalent for respiratory or pulmonary reasons Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the annual rate of decline in FVC [mL/year] assessed over a treatment period up to a maximum of 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| the absolute change from baseline in FVC at Week 24 [in mL] | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Malaysia, New zealand, Norway, Poland, Singapore, South korea, Spain, Sweden, Thailand, United kingdom, United states
Contacts
Boehringer Ingelheim