AuthorisedTherapeutic confirmatory (Phase III)Interventional

APROTININ TREATMENT OF ACUTE RESPIRATORY DISTRESS SYNDROME: A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III TRIAL

This clinical trial is investigating a new treatment named aprotonin for Acute Respiratory Distress Syndrome (ARDS), a severe lung condition where fluid builds up, making it hard to breathe. The study aims to see if aprotonin, given by inhaling it, can help patients recover faster and reduce the time they need a breathing machine (ventilator). Researchers will compare aprotonin to a harmless dummy treatment (saline solution) to find out if it's effective and safe. They will closely monitor how long patients can breathe on their own and other important health measures. The study includes adults aged 18 and over, both men and women.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacion Del Hospital Nacional De Paraplejicos Para La Investigacion Y La Integracion

Enrolment target

156

Start

14 Aug 2025

ACUTE RESPIRATORY DISTRESS SYNDROME

What is this study about?

This study is a clinical trial looking into a potential new treatment for a serious lung condition called Acute Respiratory Distress Syndrome, or ARDS. ARDS happens when your lungs become severely inflamed and fill with fluid, making it very difficult to breathe without help. Often, people with ARDS need a breathing machine, called a ventilator, to help them get enough oxygen.

The treatment being tested is called aprotonin. Researchers believe it might help reduce the inflammation in the lungs and improve how they work. To see if this is true, they're comparing aprotonin to a 'placebo', which is a dummy treatment like a saltwater solution. Neither the patients nor their doctors will know who is getting the real treatment and who is getting the placebo. This helps ensure the results are fair and accurate.

The main goal of the study is to see if aprotonin helps patients spend more days breathing on their own, without the need for a ventilator. They will also look at other important health measures, like survival rates, how other organs are working, and any side effects patients might experience. Your participation could help doctors find better ways to treat ARDS in the future.

Key takeaways

This study tests a treatment (aprotonin) for Acute Respiratory Distress Syndrome (ARDS).
It aims to see if aprotonin helps patients breathe without a ventilator sooner.
Participants will receive either aprotonin or a placebo by inhalation.
Close monitoring of health and vital signs will occur in the ICU.
Follow-up checks are planned for 90 and 180 days after starting treatment.
The study includes adult men and women, aged 18 and older.

Who may be eligible?

To join this study, particular criteria must be met. The research team will review your medical information to see if this study is right for you, however here are the general requirements.

First, you must be 18 years old or older. There is no upper age limit, meaning older adults are also welcome to take part. The study is open to both men and women.

The doctors will also need to confirm that you have been diagnosed with Acute Respiratory Distress Syndrome (ARDS) and meet other specific health requirements for the study. They will check your medical history and current health carefully to ensure the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Acute Respiratory Distress Syndrome (ARDS)?
Are you able to participate in a study while in the Intensive Care Unit (ICU)?
Are you comfortable with regular health checks and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would primarily be in an intensive care unit (ICU). You would receive either the study drug (aprotonin) or a placebo (saline solution) through inhalation, meaning you would breathe it in. This treatment would be given for a specific period during your time in the ICU.

Throughout the study, the medical team would carefully monitor your health. This involves regular checks of your vital signs, like blood pressure, heart rate, breathing rate, and temperature. They would also take blood samples periodically to check your general health and how the treatment might be affecting you. Doctors will also check how long you are able to breathe without a ventilator. These checks would continue daily while you are in the ICU for up to 28 days.

Even after you leave the ICU, some follow-up checks would be needed to see how you're doing long-term. These checks would assess your health at 90 days and 180 days after starting the treatment, to see how you're recovering and if there are any lasting effects. The total duration of your participation would involve the treatment period in the ICU and these follow-up assessments.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from a new treatment that could help your ARDS, though there's also a chance you could receive the placebo. The main goal for patients is that aprotonin may help you breathe on your own sooner. However, there's always a possibility of side effects from any medication, and the study team will closely monitor you for any adverse reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a serious lung condition where fluid fills your lungs, making it very hard to breathe and get enough oxygen.

What is aprotonin?

Aprotonin is the medicine being tested in this study. Researchers hope it might help reduce inflammation in the lungs and improve breathing in people with ARDS.

Will I know if I'm getting aprotonin or the placebo?

No, neither you nor your doctors will know whether you are receiving aprotonin or the placebo. This is to ensure the study results are as unbiased as possible.

How will the treatment be given?

The treatment, whether it's aprotonin or the placebo, will be given by inhalation, meaning you will breathe it in.

What does 'ventilator-free days' mean?

This refers to the number of days you can breathe completely on your own, without the help of a breathing machine (ventilator).