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Investigation of breathable surfactant agent in patients with idiopathic lung fibrosis
EU CTIS ID: 2023-508544-22-00
What this study is testing
To evaluate the effect of inhalative Alveofact® on the Forced Vital Capacity of IPF patients after treatment compared to placebo in the same patients
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- IPF according to International Consensus Guidelines
- Willingness of men and women of childbearing potential to use highly effective contraceptive methods
- 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
You likely can't join if
- Current / previous exacerbation / respiratory infection within the last four weeks
- Patients with known bronchial asthma
- Simultaneous participation in another clinical trial with an experimental treatment
- History of alcohol or drug abuse in the past year
- 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
See the full eligibility criteria
- IPF according to International Consensus Guidelines
- Willingness of men and women of childbearing potential to use highly effective contraceptive methods
- 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
- Current / previous exacerbation / respiratory infection within the last four weeks
- Patients with known bronchial asthma
- Simultaneous participation in another clinical trial with an experimental treatment
- History of alcohol or drug abuse in the past year
- 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
- Hypersensitivity to the active substance or any of the other ingredients
- Concomitant emphysema > 15% of lung volume (by High Resolution Computed Tomography (HRCT))
- Concomitant COPD with FEV1/FVC ratios < 70%
- Concomitant malignant disease requiring therapy
- Estimated life expectancy of less than 1 year for any reason
- Renal insufficiency (GFR < 50% predicted and/or Crea > 2mg/dl)
- Chronic liver cirrhosis > Child A
- Any other liver disease with elevated ART/ARS >3 times the upper normal limit (UNL)
- Any acute / chronic heart failure with ejection fraction of < 40%
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.