#1 Clinical Trials Search in Europe

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

3 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called Treprostinil on a lung disease known as Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition where the lungs become scarred over time, making it difficult to breathe. The study aims to evaluate how effective and safe inhaled Treprostinil is for people with this condition. Participants in the study will receive either the Treprostinil nebuliser solution or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to determine if inhaled Treprostinil can improve lung function over a period of 52 weeks. Participants will use a device called a nebuliser to inhale the medication. This device turns the liquid medication into a mist that can be easily inhaled into the lungs. The study will monitor changes in lung function and other health outcomes over the course of the year.

Throughout the study, participants will have regular check-ups to assess their lung function and overall health. The main goal is to see if there is an improvement in lung capacity, which is measured by a test called Forced Vital Capacity (FVC). The study will also look at other factors such as the time it takes for the disease to worsen, any hospitalizations due to breathing problems, and overall survival rates. This research is important for understanding how Treprostinil might help people with IPF manage their symptoms and improve their quality of life.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose and procedures. The participant must provide informed consent to participate.

Eligibility is confirmed based on specific criteria, including age, diagnosis of idiopathic pulmonary fibrosis (IPF), and lung function tests.

2 baseline assessment

Initial assessments are conducted to establish baseline health status. This includes lung function tests to measure forced vital capacity (FVC), which is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

Participants on certain medications for IPF, such as pirfenidone or nintedanib, must be on a stable dose for at least 30 days before this assessment.

3 treatment phase

Participants are randomly assigned to receive either the inhaled treprostinil or a placebo. The treatment is administered via a nebulizer, which turns the liquid medication into a mist to be inhaled.

The dosage and frequency of administration are determined by the study protocol and are consistent throughout the trial duration.

4 ongoing assessments

Regular follow-up visits are scheduled to monitor the participant’s health and response to the treatment. These visits include repeated lung function tests and other assessments as required by the study protocol.

Participants are monitored for any side effects or changes in their condition.

5 end of treatment

The treatment phase lasts until Week 52. At the end of this period, a final assessment is conducted to evaluate the change in lung function and overall health status.

The primary endpoint is the change in absolute FVC from baseline to Week 52.

6 post-study follow-up

After completing the treatment phase, participants may be asked to attend additional follow-up visits to monitor long-term effects and overall survival.

The study aims to gather data on time to clinical worsening, time to first acute exacerbation of IPF, and changes in quality of life and lung function.

Who Can Join the Study?

  • The person must agree to participate in the study by giving their voluntary informed consent.
  • The person must be 40 years of age or older at the time of signing the consent.
  • The person must have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF), confirmed by specific medical guidelines and tests.
  • The person must have a Forced Vital Capacity (FVC) of 45% or more, as predicted during screening. FVC is a measure of lung function.
  • If the person is taking medications called pirfenidone or nintedanib, they must be on a stable dose for at least 30 days before starting the study. They cannot take both medications at the same time.
  • Women who can have children must not be pregnant or breastfeeding. They must either not have intercourse or use two effective forms of birth control during the study and for 30 days after stopping the study drug.
  • Men with partners who can have children must use a condom during the study and for at least 48 hours after stopping the study drug.
  • The person must be able to communicate well with the study team and be willing to follow the study rules, including attending all study visits.

Who Cannot Join the Study?

  • Patients who have a different lung condition other than Idiopathic Pulmonary Fibrosis cannot participate. This is a specific lung disease that causes scarring of the lungs.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate in this study.
  • Patients with certain medical conditions that could interfere with the study results may not be eligible to participate.
  • Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Hospital Clinico San Carlos Madrid Spain
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Zentralklinik Bad Berka GmbH Bad Berka Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Multimedica S.p.A. Milan Italy
Romed Klinikum Rosenheim Rosenheim Germany
GWT-Tud GmbH Coswig Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Odense University Hospital Odense Denmark
Hospital Clinic De Barcelona Barcelona Spain
St. Antonius Ziekenhuis Nieuwegein The Netherlands
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Gentofte Hospital Hellerup Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Servei De Salut De Les Illes Balears Palma Spain
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hospital Universitario Virgen De La Victoria Malaga Spain
Cjvfil Hlwgqzhndii Uwdjlhmkoyitd Rtjtf Reims France
Hjjoznlk Uoqigyuudhvzl Dv Lm Pqjireuq Madrid Spain
Hppjanur Ucwbwahvfthlj Mvlkvoo Dw Vclcwzekpw Santander Spain
Aoobkzdels Pqbjczok Hcgxorjw De Msuwvkkda Marseille France
Ezkvadn Ulzzcamjoyxt Mlfslcq Cfuojid Rajeahuye (pfumbvh Mcs Rotterdam The Netherlands
Axccewi Ohdnpnpdmnn Uhllefawmsenk Spgjpb Siena Italy
Aupatz Uxkmqzofge Hgsizvdw Aarhus Denmark
Ctygbc Hzjzzoczbtn Rzbjqhlw Ukuczeghvplbn Du Tjbxe Tours France
Kpwyqfaq dzc Uixebtyjpwzp Mtowsdcn Apb Munich Germany
Hxdmmciy Vbnz dvpvrjtj Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
04.10.2022
Denmark Denmark
Not recruiting
04.10.2022
France France
Not recruiting
04.10.2022
Germany Germany
Not recruiting
04.10.2022
Italy Italy
Not recruiting
04.10.2022
Spain Spain
Not recruiting
04.10.2022
The Netherlands The Netherlands
Not recruiting
04.10.2022

Trial locations

Investigated drugs:

Treprostinil is a medication used in this clinical trial to help people with idiopathic pulmonary fibrosis. It is administered through inhalation, which means it is breathed in directly into the lungs. The goal of using treprostinil in this study is to see if it can improve lung function over a period of time, specifically by measuring changes in lung capacity from the start of the trial to one year later. This medication works by helping to open up the blood vessels in the lungs, which can improve breathing and reduce symptoms associated with the disease.

Investigated diseases:

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis is a chronic lung disease characterized by the thickening and scarring of lung tissue. This scarring, known as fibrosis, leads to a progressive decline in lung function. The exact cause of the disease is unknown, which is why it is termed “idiopathic.” Over time, the scarring makes it difficult for the lungs to transfer oxygen into the bloodstream. Patients may experience symptoms such as shortness of breath, a persistent dry cough, and fatigue. The disease typically progresses over several years, with symptoms gradually worsening.

Trial ID:
2024-514761-19-00
Protocol code:
RIN-PF-303
NCT ID:
NCT05255991
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of MTX-463 compared to placebo to assess its safety and effectiveness in adults with idiopathic pulmonary fibrosis

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Croatia France Ireland The Netherlands Spain

  • Study of BI 765423 given by intravenous infusion for patients with idiopathic pulmonary fibrosis with or without standard treatment

    Recruiting

    2 1
    Investigated diseases:
    Belgium Germany Italy Spain