Investigation of breathable surfactant agent in patients with idiopathic lung fibrosis

Prior treatment

• Current / previous exacerbation / respiratory infection within the last four weeks
• Concomitant emphysema > 15% of lung volume (by High Resolution Computed Tomography (HRCT))
• Concomitant COPD with FEV1/FVC ratios < 70%
• Concomitant malignant disease requiring therapy

Other illness

• History of alcohol or drug abuse in the past year
• Hypersensitivity to the active substance or any of the other ingredients
• Any other liver disease with elevated ART/ARS >3 times the upper normal limit (UNL)

Lab values

• Renal insufficiency (GFR < 50% predicted and/or Crea > 2mg/dl)
• Any acute / chronic heart failure with ejection fraction of < 40%

Other

• Patients with known bronchial asthma
• Simultaneous participation in another clinical trial with an experimental treatment
• Assessment by the investigator that the patient should not participate in the study if the patient is unlikely to be able to comply with the study procedures, limitations and requirements
• Pregnancy or breastfeeding
• Estimated life expectancy of less than 1 year for any reason
• Chronic liver cirrhosis > Child A

• IPF according to International Consensus Guidelines
• For women of childbearing potential: A negative result in highly sensitive pregnancy test. Willingness of women of childbearing potential (WOCBP) to use acceptable effective methods of contraception* during treatment and until treatment discontinuation.
• Forced Vital Capacity (FVC) > 75% predicted
• Diffusion Capacity for CO (TLCO) > 40% predicted
• Capillary pO2 > 60 mm Hg at rest
• No need for supplemental oxygen at rest
• Treatment-naive patients or patients treated with standard of care for more than 3 months. Treatment naive patients can only be included if they have previously failed on SOC medication. No standard of care medication will be withheld from participants of the study.
• Patient must be ≥ 18 years old
• Signed written informed consent
• Ability and willingness to comply with study procedures