Study on Pirfenidone for Preventing Lung Fibrosis in Patients with Acute Respiratory Distress Syndrome (ARDS)

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What is this study about?

This clinical trial is focused on studying a condition known as Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious lung condition that causes difficulty in breathing. The study is testing a medication called Pirfenidone, which is being evaluated for its potential to prevent lung scarring in patients with ARDS. The trial will compare the effects of Pirfenidone to a placebo, which is a substance with no active medication.

The main goal of the study is to see if Pirfenidone can increase the number of days patients can breathe without the help of a ventilator by day 28. Participants in the study will receive either Pirfenidone or a placebo, and their progress will be monitored over a period of 28 days. The study will also look at other outcomes, such as the number of days patients spend outside of the intensive care unit (ICU), improvements in lung function, and overall quality of life.

Throughout the study, various tests and assessments will be conducted to gather information on the effectiveness and safety of Pirfenidone. These include checking for changes in lung tissue using high-resolution computed tomography (CT) scans, measuring heart function with echocardiography, and evaluating physical performance through a six-minute walk test. The study aims to provide valuable insights into the potential benefits of Pirfenidone for patients with ARDS.

1 joining the study

Participation begins after meeting specific criteria, including having moderate or severe acute respiratory distress syndrome (ARDS) as defined by the Berlin definition.

Consent must be provided by the patient, a legal representative, or as indicated by an ethical committee.

2 treatment administration

The treatment involves the administration of pirfenidone, which is provided in the form of 267 mg film-coated tablets known as Esbriet.

The medication is taken orally, or through a nasogastric tube or percutaneous endoscopic gastrostomy tube, depending on the patient’s condition.

The treatment aims to increase the number of ventilator-free days by day 28 compared to a placebo group.

3 monitoring and assessments

Throughout the trial, various health parameters are monitored, including the number of intensive care unit (ICU)-free days and the cumulative SOFA-free score at day 28.

Additional assessments include the length of hospital stay, changes in lung condition as seen on high-resolution CT scans, and overall mortality at ICU or hospital discharge.

4 follow-up evaluations

Upon discharge from the hospital, pulmonary function tests such as spirometry are conducted to evaluate lung function.

Further evaluations include a six-minute walk test conducted between 6 to 12 months after discharge to assess physical endurance.

5 quality of life assessment

Quality of life is measured using the EQ-5D Health Questionnaire and the SF-36 questionnaire to understand the impact of the treatment on daily living.

Heart function is also assessed through echocardiography at ICU discharge to check for any dysfunction.

6 adverse events and additional therapies

The trial monitors any adverse events that may occur during the treatment period.

The use of additional therapies for severe low oxygen levels is also documented.

Who Can Join the Study?

The patient must have Acute Respiratory Distress Syndrome (ARDS), which is a serious lung condition. It should be either moderate or severe, as defined by the Berlin definition.
The patient must have an inflammatory ARDS phenotype, which means their ARDS is related to inflammation. This can be shown by at least one of the following:
- High levels of inflammatory markers in the blood, such as IL-6 greater than 80 pg/ml or PCR greater than 250 mg/l.
- Dependence on vasopressors, which are medications that help raise blood pressure, for at least one hour.
- Low levels of serum bicarbonate (less than 18 mmol/l) or high levels of serum lactate (greater than 4 mmol/l).
The patient or their legal representative must give informed consent, which means they agree to participate in the study after understanding what it involves.
The study is open to both male and female participants.
The study includes participants from a vulnerable population, which means they might need special protection or consideration.

Who Cannot Join the Study?

Patients who have a known allergy or sensitivity to the study medication, which is called Pirfenidone.
Patients who are currently participating in another clinical trial.
Patients with a history of severe liver disease, which means the liver is not working properly.
Patients with a history of severe kidney disease, which means the kidneys are not working properly.
Patients who are pregnant or breastfeeding.
Patients who have a history of certain heart conditions, such as a recent heart attack.
Patients who have a history of certain lung conditions, such as severe asthma.
Patients who have a history of certain blood disorders, which affect how blood cells work.
Patients who have a history of certain immune system disorders, which affect how the body fights infections.
Patients who have a history of certain mental health conditions, such as severe depression.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Ospedale Uboldo – ASST Melegnano e Martesana	Cernusco sul Naviglio (MI)	Italy
Ospedale di Merano – Sabes	Merano	Italy
Ospedale dell’Angelo di Mestre	Mestre – Venezia	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Centro Cardiologico Monzino S.p.A.	Milan	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Istituto Oncologico Veneto	Padua	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Universita’ Di Pisa	Pisa	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
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Sdbfi Myyyh Ssrnfc	Bari	Italy
Pwjcfh Gguulo Hjzazuxa	Castel Volturno (CE)	Italy
Akoolry Oehcujemcrs Rdawahhhf Sjq Cqidv	Potenza	Italy
Uymehgmwxa Mcpmb Gavxfyw Ov Cxcnqgtvw	Catanzaro	Italy
Alfkqsc Oqfcfwjvses Uzffqrqkduktj Skudyt	Siena	Italy
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Ajhzbvs Omeasoryfik Ndfkzbhfn Sy Arehaar E Bvghyw E C Akqdql Ahuxgsfeutu	Alexandria	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	20.09.2021

Trial locations

Investigated drugs:

Pirfenidone is a medication being tested in this clinical trial to see if it can help prevent lung fibrosis in patients with Acute Respiratory Distress Syndrome (ARDS). The goal is to see if patients taking Pirfenidone have more days without needing a ventilator within the first 28 days compared to those who do not receive the medication.

Investigated diseases:

Acute respiratory distress syndrome

Acute Respiratory Distress Syndrome (ARDS) – ARDS is a severe lung condition that occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in the lungs. This fluid prevents the lungs from filling with enough air, which means less oxygen reaches the bloodstream. As a result, organs may not get the oxygen they need to function properly. ARDS typically develops in people who are already critically ill or who have significant injuries. The condition progresses rapidly, often within a few hours to a few days after the initial injury or illness. It can lead to severe shortness of breath and requires immediate medical attention.

Trial ID:

2024-514355-16-01

Protocol code:

GR-2019-12371063

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pirfenidone for Preventing Lung Fibrosis in Patients with Acute Respiratory Distress Syndrome (ARDS)

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