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Study on Inhaled Phospholipid Fraction from Bovine Lung for Patients with Idiopathic Pulmonary Fibrosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a lung disease called Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred and breathing becomes difficult over time. The study will use a treatment called Alveofact®, which is a type of natural substance derived from cow lungs. This substance is known as a phospholipid fraction and is used to help improve lung function. The treatment will be given to patients through a device called a nebulizer, which allows the medication to be inhaled directly into the lungs.

The purpose of the study is to evaluate how effective inhaling Alveofact® is in improving lung function in patients with IPF. The study will compare the effects of the treatment to a placebo, which is a substance with no active medication. Participants will receive the treatment over a period of time, and their lung function will be measured to see if there are any improvements. The main focus will be on changes in the Forced Vital Capacity (FVC), which is a measure of how much air a person can exhale after taking a deep breath.

Throughout the study, participants will undergo various assessments to monitor their lung health and overall well-being. These assessments will include measuring lung capacity, oxygen levels, and the distance they can walk in six minutes. The study aims to provide valuable information on whether inhaling Alveofact® can help improve breathing and quality of life for people with IPF. Participants will be closely monitored for any side effects or changes in their condition during the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must meet specific criteria, including a diagnosis of idiopathic pulmonary fibrosis (IPF) according to international guidelines, and a willingness to use effective contraceptive methods if of childbearing potential.

    The patient must have a Forced Vital Capacity (FVC) greater than 75% predicted, a Diffusion Capacity for CO (TLCO) greater than 40% predicted, and a capillary pO2 greater than 60 mm Hg at rest.

    The patient should not require supplemental oxygen at rest and must be either treatment-naive or have been treated with standard care for more than three months.

    The patient must be at least 18 years old, provide signed written informed consent, and be able and willing to comply with study procedures.

  2. Step 2

    Treatment phase

    The patient will receive the medication Alveofact®, which is a surfactant agent administered through inhalation.

    The medication is provided as a powder and solvent to create a suspension for inhalation.

    The primary goal is to evaluate the effect of inhaled Alveofact® on the patient's lung function, specifically the Forced Vital Capacity (FVC).

  3. Step 3

    Evaluation of primary endpoint

    The primary endpoint is the mean intra-individual difference in the percentage change in FVC from baseline to the end of each inhalation phase.

    This will help determine the effectiveness of the treatment in improving lung function.

  4. Step 4

    Evaluation of secondary endpoints

    Secondary endpoints include changes in Total Lung Capacity (TLC), Forced Expiratory Volume in one second (FEV1), and other lung function parameters from baseline to the end of each inhalation phase.

    Additional assessments include changes in diffusion capacity for CO, arterial partial pressure of O2, and O2 saturation during rest and exercise.

    The study will also assess changes in the 6-minute walking distance and other lung function measures.

    Patient-related outcomes will be measured using specific questionnaires.

  5. Step 5

    Safety and toxicity assessment

    Throughout the study, safety and toxicity will be monitored, including any adverse events (AEs) or serious adverse events (SAEs).

    This ensures the treatment is safe for the patient.

  6. Step 6

    Completion of the study

    The study is estimated to end by December 31, 2025.

    The patient will have completed all required assessments and treatments by this time.

Who can join the trial?

10 criteria

  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) according to International Consensus Guidelines. IPF is a lung disease that causes scarring of the lungs.
  • Men and women who can have children must agree to use highly effective birth control methods.
  • Forced Vital Capacity (FVC) must be more than 75% of what is predicted. FVC is a measure of how much air you can exhale after taking a deep breath.
  • Diffusion Capacity for Carbon Monoxide (TLCO) must be more than 40% of what is predicted. TLCO measures how well your lungs can transfer oxygen into your blood.
  • Capillary pO2 must be more than 60 mm Hg at rest. This measures the amount of oxygen in your blood.
  • No need for extra oxygen while resting.
  • Patients who have not been treated before or those treated with standard care for more than 3 months. Untreated patients can only join if they did not respond to standard care medication. No standard care medication will be stopped for study participants.
  • Must be 18 years old or older.
  • Must sign a written informed consent form, which means you agree to participate after understanding the study.
  • Must be able and willing to follow the study procedures.
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Investigated drugs

Alveofact is an inhaled medication used in this study to help patients with Idiopathic Pulmonary Fibrosis (IPF). It is a type of pulmonary surfactant, which means it helps reduce surface tension in the lungs, making it easier for patients to breathe. The study aims to see how this medication affects the lung function of IPF patients, specifically looking at their Forced Vital Capacity, which is a measure of how much air they can exhale after taking a deep breath.

What is already known about the treatment

Alveofact – This medication is administered through inhalation, specifically designed for patients with idiopathic pulmonary fibrosis. It is currently being studied in clinical trials to assess its effectiveness in improving lung function, particularly focusing on forced vital capacity. Alveofact is primarily indicated for use in respiratory conditions where lung surfactant is deficient or dysfunctional. At the molecular level, it works by supplementing the natural surfactant in the lungs, which helps reduce surface tension and improve breathing. It is classified pharmacologically as a pulmonary surfactant.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the progressive scarring of lung tissue. This scarring, or fibrosis, leads to a gradual decline in lung function, making it increasingly difficult for the lungs to transport oxygen into the bloodstream. The exact cause of the disease is unknown, which is why it is termed "idiopathic." Over time, the thickening and stiffening of lung tissue can result in symptoms such as persistent dry cough and shortness of breath, especially during physical activity. As the disease progresses, patients may experience fatigue and a decrease in exercise tolerance. The progression of the disease varies among individuals, with some experiencing a rapid decline in lung function while others may have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508544-22-00Protocol codeKKS-310Estimated enrolment20 patientsSponsorPhilipps-Universitaet Marburg

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