Investigation of breathable surfactant agent in patients with idiopathic lung fibrosis
Key facts
- Where
- Giessen és Munich, NémetországSee the 2 sites
- Phase
- 2. fázis
Where in Németország
- Justus-Liebig-Universitaet GiessenGiessen, NémetországToborzás még nem indult
- Klinikum der Universitaet Muenchen AöRMunich, NémetországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Philipps-Universitaet Marburg
- Trial code
- EU 2023-508544-22-00
- Record updated
- 2026. augusztus 4.
- Original description
To evaluate the effect of inhalative Alveofact® on the Forced Vital Capacity of IPF patients after treatment compared to placebo in the same patientsRead full original descriptionShow less
Proof-of-principle study of inhaled pulmonary surfactant in patients with Idiopathic Pulmonary Fibrosis (INSURF-IPF)
To evaluate the effect of inhalative Alveofact® on the Forced Vital Capacity of IPF patients after treatment compared to placebo in the same patients
Inclusion: 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.
Exclusion: 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; 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); Renal insufficiency (GFR < 50% predicted and/or Crea > 2mg/dl); Any acute / chronic heart failure with ejection fraction of < 40%; 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.