Study on the Effects of Inhaled Treprostinil for Patients with Progressive Pulmonary Fibrosis

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What is this study about?

This clinical trial is focused on studying a lung disease called Progressive Pulmonary Fibrosis (PPF). PPF is a condition where the lungs become scarred over time, making it difficult to breathe. The study will test a treatment called Treprostinil, which is given as a solution to be inhaled using a nebulizer. A nebulizer is a device that turns liquid medicine into a mist, making it easier to breathe in. The study will compare the effects of Treprostinil with a placebo, which looks like the real treatment but does not contain the active drug.

The purpose of the study is to see if inhaled Treprostinil can improve lung function in people with PPF over a period of 52 weeks, which is about one year. Participants will be randomly assigned to receive either Treprostinil or the placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. Throughout the study, participants will have regular check-ups to monitor their lung function and overall health.

Participants will be observed for any changes in their condition, including lung function and symptoms, as well as any side effects from the treatment. The study will also look at how long it takes for any worsening of the disease to occur and will track overall survival rates. The goal is to determine if Treprostinil can help slow down the progression of PPF and improve the quality of life for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

A high-resolution computed tomography (HRCT) scan is used to verify the extent of pulmonary fibrosis, which must be greater than 10%.

2 baseline measurements

Baseline measurements are taken to establish a starting point for the study. This includes measuring the forced vital capacity (FVC), which is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

Other baseline assessments include blood tests, vital signs, and a 12-lead electrocardiogram.

3 randomization and treatment

Participants are randomly assigned to receive either the inhaled treprostinil or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the active treatment.

The medication is administered via inhalation using a nebulizer. The dosage and frequency are determined by the study protocol.

4 ongoing assessments

Regular assessments are conducted throughout the study to monitor health and response to treatment. These include measuring changes in FVC at weeks 16, 28, 40, and 52.

Additional assessments include monitoring for any adverse events, changes in respiratory symptoms, and overall survival.

5 final evaluation

At the end of the 52-week study period, a final evaluation is conducted. This includes a comprehensive review of all collected data, including changes in FVC, respiratory symptoms, and any adverse events experienced during the study.

The results are used to determine the efficacy and safety of the inhaled treprostinil treatment.

Who Can Join the Study?

The person must give their voluntary informed consent to join the study. This means they agree to participate after understanding what the study involves.
The study doctor believes the person can communicate well with the study team and will follow the study rules, including attending all study visits.
The person must be at least 18 years old when they sign the consent form.
The person must have a scan showing more than 10% of their lungs affected by fibrosis, which is a type of lung scarring, in the past 12 months.
The person must have a diagnosis of Progressive Pulmonary Fibrosis (PPF), which is a type of lung disease, and meet at least one of the following conditions for worsening within 24 months despite standard treatment:
- A significant drop in lung function, measured by a test called FVC (Forced Vital Capacity), by 10% or more.
- A smaller drop in FVC by 5% to less than 10%, along with worsening breathing symptoms.
- A smaller drop in FVC by 5% to less than 10%, along with more lung scarring seen on chest images.
- Worsening breathing symptoms and more lung scarring seen on chest images.
The person’s FVC must be at least 45% of what is predicted for their age and size at the start of the study.
The person must be on one of the following treatments:
- Taking nintedanib or pirfenidone for at least 90 days before the study starts and planning to continue during the study.
- Not taking nintedanib or pirfenidone for at least 90 days before the study starts and not planning to start during the study.
Taking both nintedanib and pirfenidone at the same time is not allowed.
If the person is taking medications that suppress the immune system, like mycophenolate or methotrexate, they must have been on these for at least 120 days before the study starts and not responding to them.
Women who can have children must not be pregnant or breastfeeding and must agree to:
- Not have sexual intercourse, if this is their usual lifestyle.
- Use two highly effective forms of birth control during the study and for at least 30 days after stopping the study drug. These can include hormonal contraceptives or barrier methods like condoms.
Women who are sterilized or have gone through menopause are not considered able to have children.
Men with partners who can have children must agree to use a condom during treatment and for at least 48 hours after stopping the study drug.

Who Cannot Join the Study?

Patients with other serious lung diseases that are not related to Progressive Pulmonary Fibrosis (PPF) cannot participate. PPF is a condition where the lungs become scarred over time, making it hard to breathe.
Individuals who have had a recent lung infection or illness that affects their breathing may be excluded.
People who have had a recent surgery or are planning to have surgery during the study period might not be eligible.
Participants who are currently taking certain medications that could interfere with the study treatment may be excluded.
Individuals with a history of severe allergic reactions to similar medications may not be able to join the study.
Pregnant or breastfeeding women are typically not allowed to participate in clinical trials to ensure the safety of the mother and child.
Patients with certain heart conditions that could be worsened by the study treatment may be excluded.
Individuals who are unable to follow the study procedures or attend regular check-ups may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Lungenfachklinik	Immenhausen	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Zentralklinik Bad Berka GmbH	Bad Berka	Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Romed Klinikum Rosenheim	Rosenheim	Germany
GWT-Tud GmbH	Coswig	Germany
Thoraxzentrum Bezirk Unterfranken	Muennerstadt	Germany
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universita’ Politecnica Delle Marche	Ancona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Gasthuiszusters Antwerpen	Antwerp	Belgium
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Cakfztacj Ubayqivfmcfbzw Sptygcewb	Woluwe-Saint-Lambert	Belgium
Uklaiwqnwj Mhqomrg Cqqjug Hthagnggpggfsrimj	Hamburg	Germany
Hwljzvxs Ucnrpanwqdjuy Mjzdkzf Dl Vypmdrmdig	Santander	Spain
Oadrpoooteepbdtieyfgqdabxg	Aalst	Belgium
Aehzgockjf Piaxntfx Hzrzozyb Dg Mnvwzjhuw	Marseille	France
Acsqxrl Ohiocobriba Umltqzwhyncbl Sfysly	Siena	Italy
Cvydis Hwcokiyrjuh Repcclqx Uqaygxwdohwhj Ds Taunq	Tours	France
Kmwcoqjv dcc Uloyechzxmet Mjpnojcy Azm	Munich	Germany
Umswojxjuu Op Aojhsoq	Edegem	Belgium
Hfyagket Vpso dngrufnl	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.03.2025
France	Recruiting	01.03.2025
Germany	Recruiting	01.03.2025
Italy	Recruiting	01.03.2025
Spain	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Treprostinil

Treprostinil is a medication used in this study to help people with progressive pulmonary fibrosis. It is inhaled, which means you breathe it in, and it works by helping to improve blood flow in the lungs. This can help make breathing easier and improve lung function over time. The study aims to see how well this medication works compared to not using it.

Investigated diseases:

Pulmonary fibrosis

Progressive Pulmonary Fibrosis – This is a lung disease characterized by the gradual scarring of lung tissue, which leads to a decline in lung function over time. The scarring, or fibrosis, makes it difficult for the lungs to work properly, reducing the ability to breathe deeply. As the disease progresses, individuals may experience increasing shortness of breath, a persistent dry cough, and fatigue. The condition can lead to a decrease in the amount of oxygen that reaches the bloodstream, affecting overall health. The progression of the disease varies among individuals, with some experiencing a slow decline and others a more rapid deterioration.

Trial ID:

2023-504904-26-00

Protocol code:

RIN-PF-305

NCT ID:

NCT05943535

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Inhaled Treprostinil for Patients with Progressive Pulmonary Fibrosis

What is this study about?

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