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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
Hospital General Universitario De Albacete	Albacete	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Hospital General Universitario De Ciudad Real	Ciudad Real	Spain
Hbbavlza Udrulzfprmrvf Da Lv Pqjopmlx	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.09.2025

Trial locations

Investigated drugs:

APROTININ

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).

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 ID:

2025-520826-39-00

Protocol code:

ICI24/00011

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?