AuthorisedTherapeutic confirmatory (Phase III)Interventional

PIrfenidone to prevent fibrOsis in ARDS. A RaNdomizEd controllEd tRial - PIONEER

The PIONEER study is looking into a new treatment called Pirfenidone for Acute Respiratory Distress Syndrome (ARDS). ARDS is a severe lung condition where the lungs become inflamed and struggle to get enough oxygen. This study aims to find out if Pirfenidone can help people with ARDS recover better and faster. Researchers will compare patients who receive Pirfenidone to those who receive a 'dummy' pill (placebo). The main thing they want to see is if patients taking Pirfenidone can come off breathing machines sooner. They will also look at how long people stay in intensive care, how serious their illness is, and how their lungs heal over time. The ultimate goal is to improve recovery and quality of life for people with this serious condition.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Ospedale San Raffaele S.r.l.

Enrolment target

100

Start

08 Jan 2025

Acute Respiratory Distress Syndrome (ARDS)

What is this study about?

Imagine your lungs are like sponges, normally soft and full of air. In a condition called Acute Respiratory Distress Syndrome, or ARDS, your lungs become seriously inflamed and stiff, making it very hard to breathe. People with ARDS often need help from a breathing machine, called a ventilator, in an intensive care unit (ICU).

This study, called PIONEER, is testing a medicine called Pirfenidone. Researchers believe Pirfenidone might help prevent the lungs from getting too scarred or stiff, a process called fibrosis, which can happen after ARDS. If this medicine works, it could help people recover better and reduce the long-term effects of ARDS. They want to see if it helps patients spend more time breathing on their own, rather than relying on a breathing machine.

To find this out, some patients will receive Pirfenidone, while others will receive a 'placebo' – a dummy pill that looks just like the study medicine but contains no active ingredient. This is a common way to test new treatments fairly. The study will carefully watch how patients recover, examining things like how long they stay in intensive care, how well their lungs are working, and their overall health and quality of life after leaving the hospital.

Key takeaways

The PIONEER study aims to improve recovery for people with critical lung illness (ARDS).
It tests if a medicine called Pirfenidone helps people breathe on their own sooner.
Participation involves taking tablets and careful monitoring in hospital, with follow-up after.
Half of participants will get the study medicine, half will get a dummy pill (placebo).
The study hopes to reduce long-term lung scarring and improve quality of life.

Who may be eligible?

To join the PIONEER study, you need to be at least 18 years old – there's no upper age limit. Both men and women can take part.

You would be considered for this study if you have been diagnosed with Acute Respiratory Distress Syndrome (ARDS) and are still quite unwell from it, potentially needing help from a breathing machine. The study team will check other specific medical details to make sure the study is a good fit for you and that taking part would be safe.

It's important to understand that not everyone with ARDS will be able to join. The study has careful rules about who can take part to make sure the results are clear and reliable. If you are interested, the study doctor will go through all the details with 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 at least 18 years old?
Have you been diagnosed with Acute Respiratory Distress Syndrome (ARDS)?
Are you currently in hospital with ARDS, potentially on a breathing machine?
Are you willing to take study medicine (or placebo) and attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you join the PIONEER study, you would receive either the study medicine, Pirfenidone, or a placebo (a dummy pill) for a certain period while in the hospital. The medicine is given as tablets. You would also receive standard medical care for ARDS.

The research team will closely monitor your health and recovery while you are in intensive care and in the hospital. This would involve regular check-ups, blood tests, and scans to see how your lungs are healing. They would be particularly interested in how long you need a breathing machine and how quickly you recover.

After leaving the hospital, there might be follow-up appointments several months later. These appointments could involve tests like checking your breathing (spirometry) or a simple walking test to assess your recovery. You might also be asked to fill out questionnaires about your quality of life. The exact duration of your participation, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer medical attention and potentially receive a treatment that could improve your recovery from ARDS, although it's also possible you will receive the placebo. Pirfenidone is an approved medicine for other conditions and generally well-tolerated, but like all medicines, it can have side effects. These will be fully explained by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care. Your safety and well-being are the top priority throughout the study.

Locations (1)

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

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Unverified
Italy

Common questions

What is ARDS?

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

What is Pirfenidone?

Pirfenidone is a medicine that's being tested in this study to see if it can help prevent scarring and stiffness in the lungs of people with ARDS. It's already used for other lung conditions.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the study medicine but doesn't contain any active ingredient. It helps researchers compare how well the real medicine works.

How long will I be in the study?

The study involves taking medicine while you're in hospital, and then follow-up appointments for several months after you leave. The exact length will be discussed with you.

Will I know if I'm getting the real medicine or the placebo?

No, it's a 'blinded' study, meaning neither you nor your doctors will know whether you're getting Pirfenidone or the placebo to ensure fair and accurate results.