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Study of inhaled aprotinin for treatment of moderate to severe acute respiratory distress syndrome

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What is this trial about?

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

This study focuses on treating patients with Acute Respiratory Distress Syndrome (ARDS), a serious condition where the lungs become severely inflamed, making it difficult to breathe. The research aims to determine if aprotinin, given through inhalation, can improve the condition of patients with moderate or severe ARDS and reduce their need for breathing support from machines.

The treatment being tested is inhaled aprotinin, a substance that helps control inflammation by blocking certain proteins in the body. During the study, some patients will receive aprotinin through an inhaler, while others will receive a saline solution. The medication or saline solution will be given to patients who are already using breathing machines in the hospital's intensive care unit.

The study will monitor how long patients need to use breathing machines, track their overall health status, and observe their recovery over several months. Doctors will regularly check patients' blood samples, vital signs, and general health condition to ensure their safety throughout the treatment period. The total treatment time with the study medication can last up to six months.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    After being diagnosed with moderate or severe acute respiratory distress syndrome (ARDS), you will be evaluated for participation if you are already on a breathing machine (mechanical ventilation).

    The assessment must occur within 48 hours of your ARDS diagnosis.

    You must be at least 18 years old to participate.

  2. Step 2

    Treatment initiation

    You will receive either inhaled aprotinin solution (200 KIU/mL) or a saline solution through inhalation.

    The treatment will begin while you are on mechanical ventilation in the intensive care unit (ICU).

  3. Step 3

    Daily monitoring in ICU

    Your vital signs will be monitored daily, including blood pressure, heart rate, breathing rate, temperature, and heart activity (ECG).

    Blood samples will be taken daily for laboratory tests while you remain in the ICU, continuing up to day 28.

    Your breathing ability will be assessed to determine when you can breathe without machine assistance.

  4. Step 4

    Follow-up assessments

    Your progress will be evaluated at day 28, day 90, and day 180 after treatment begins.

    The medical team will assess your organ function, need for breathing support, kidney support, and blood pressure medication.

    At day 180, you will be evaluated for muscle weakness and neurological function.

  5. Step 5

    Safety monitoring

    Throughout the study period, any changes in your health condition will be monitored and recorded.

    Laboratory test results will be regularly reviewed to ensure your safety.

    The total duration of the study is from September 2025 to September 2029.

Who can join the trial?

7 criteria

  • Patient must be diagnosed with moderate or severe ARDS (Acute Respiratory Distress Syndrome) meeting these conditions:
    • Breathing problems must start within 1 week of a known medical event or worsening breathing symptoms
    • Breathing problems not caused by heart failure or excess fluid in the body
    • Chest imaging and oxygen level tests must be performed within the same 24-hour period
    • Treatment must begin within 48 hours of being diagnosed with moderate or severe ARDS
    • Patient must be using a breathing tube and ventilator (a machine that helps with breathing)
    • Patient must be 18 years or older
    • Both men and women can participate in the study

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • History of allergic reactions to aprotinin (the study medication) or similar medications
  • Current participation in other clinical trials
  • Severe liver disease (problems with liver function)
  • Severe kidney disease (problems with kidney function)
  • Uncontrolled bleeding disorders
  • Active infections requiring antibiotic treatment
  • Major surgery within the last 30 days
  • Severe heart conditions that are not well controlled
  • History of blood clotting disorders
  • Use of blood-thinning medications in the past 7 days
  • Any condition that the doctor considers might interfere with the study results
  • Unable to provide informed consent
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Investigated drugs

Aprotinin is a medication that helps reduce inflammation and protect organs during severe breathing problems. It is being studied to help patients with Acute Respiratory Distress Syndrome (ARDS), a serious condition where the lungs become severely inflamed. The medication works by blocking certain proteins in the body that cause inflammation, potentially helping patients breathe better and possibly reducing their need for mechanical ventilation (breathing machines).

What is already known about the treatment

Aprotinin - A protein-based medication administered intravenously that works as a potent protease inhibitor, primarily used in critical care settings to manage Acute Respiratory Distress Syndrome (ARDS). This drug functions by blocking several protein-degrading enzymes in the body, which helps reduce inflammation and prevent tissue damage in the lungs. Currently undergoing Phase III clinical trials for ARDS treatment, aprotinin has shown promise in potentially reducing the need for mechanical ventilation in patients with moderate to severe respiratory distress. It belongs to the pharmacological class of antifibrinolytic agents and has been previously used in cardiac surgery to reduce blood loss.

Investigated diseases

Acute Respiratory Distress Syndrome - A serious lung condition that develops rapidly in response to severe injury or illness affecting the lungs. It occurs when fluid builds up in the tiny air sacs (alveoli) in the lungs, reducing the amount of oxygen that reaches the bloodstream. The condition causes breathing difficulties and leads to decreased oxygen levels in the blood. The lungs become stiff and inflamed, making it harder for oxygen to pass from the air sacs into the bloodstream. This condition typically develops within hours to days of the triggering event or illness. Patients experience severe shortness of breath, rapid breathing, and may have bluish skin coloration due to low oxygen levels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520826-39-00Protocol codeICI24/00011Estimated enrolment156 patientsSponsorFundacion Del Hospital Nacional De Paraplejicos Para La Investigacion Y La Integracion

sourced from the EU Clinical Trials Register and site verification

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