Study on Long-Term Safety of Inhaled Treprostinil for Patients with Fibrotic Lung Disease

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What is this study about?

This clinical trial is focused on studying a condition known as Fibrotic Lung Disease, which involves scarring of the lung tissue that can make breathing difficult. The treatment being tested in this study is called Treprostinil, which is administered as a nebuliser solution. A nebuliser is a device that turns liquid medicine into a mist, making it easier to inhale directly into the lungs. The purpose of this study is to evaluate the long-term safety and tolerability of inhaled Treprostinil in individuals with this lung condition.

Participants in the study will use the Treprostinil nebuliser solution with a device known as the TD-300/A (TD-300), which is part of the Tyvaso Inhalation System. This system includes nebulisers and necessary accessories to help deliver the medication effectively. The study will observe participants over a period to monitor how well they tolerate the treatment and to gather information on any potential side effects.

Throughout the study, researchers will assess various health parameters, such as lung function and overall survival, to understand the effects of continued long-term therapy with Treprostinil. The study aims to provide valuable insights into the treatment’s impact on the progression of Fibrotic Lung Disease and its potential benefits for patients living with this condition.

1 entry into the study

Upon joining the study, the participant will begin by providing informed consent, confirming their understanding and agreement to participate.

A urine pregnancy test will be conducted for women of childbearing potential to confirm non-pregnancy.

2 initial assessment

An initial assessment will be conducted to evaluate the participant’s current health status. This includes reviewing medical history and conducting necessary tests to establish a baseline for the study.

3 medication administration

Participants will begin treatment with Treprostinil, administered as a nebulizer solution for inhalation. The dosage and frequency will be determined by the study protocol and adjusted as necessary based on individual response and tolerability.

4 regular follow-up visits

Participants will attend regular follow-up visits to monitor the effects of the medication. These visits will include assessments of lung function, overall health, and any side effects experienced.

Vital signs, including oxygen levels, will be checked, and additional tests such as electrocardiograms (ECGs) may be performed.

5 long-term monitoring

The study aims to evaluate the long-term safety and tolerability of inhaled Treprostinil. Participants will be monitored for changes in lung function, time to clinical worsening, and overall survival.

Safety will be assessed through the review of adverse events, laboratory parameters, and other clinical evaluations.

6 completion of study

The study is estimated to conclude by May 31, 2027. Upon completion, participants will undergo a final assessment to evaluate the overall impact of the treatment.

Who Can Join the Study?

  • The patient must give their voluntary informed consent to join the study. This means they agree to participate after being fully informed about the study.
  • The patient must have participated in one of the previous studies: RIN-PF-301, RIN-PF-303, or RIN-PF-305, and either completed all scheduled visits or was part of the study when it was stopped for reasons other than safety.
  • Women who can have children must not be pregnant, as confirmed by a urine pregnancy test, and must not be breastfeeding. They must agree to either not have intercourse or use two highly effective forms of birth control during the study and for at least 30 days after stopping the study drug. Birth control methods can include hormonal contraceptives (like pills or injections) and barrier methods (like condoms or diaphragms) used with a spermicide. Women who are unable to have children or are postmenopausal do not need to follow these requirements.
  • Men with a partner who can have children must agree to use a condom during treatment and for at least 48 hours after stopping the study drug.
  • The patient must be able to communicate well with the study team and be considered reliable, willing, and likely to follow the study requirements, including attending all study visits.

Who Cannot Join the Study?

  • Patients with other types of lung diseases that are not related to fibrosis cannot participate.
  • Individuals who have not been diagnosed with either IPF (Idiopathic Pulmonary Fibrosis) or PPF (Progressive Pulmonary Fibrosis) are excluded.
  • Participants who are not within the specified age range for the study are not eligible.
  • People who are unable to follow the study procedures or take the study medication as required will be excluded.
  • Individuals who are part of a vulnerable population, which means they might have difficulty giving informed consent or understanding the study, 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
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Hospital Clinico San Carlos Madrid Spain
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Zentralklinik Bad Berka GmbH Bad Berka Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Gentofte Hospital Hellerup Denmark
Romed Klinikum Rosenheim Rosenheim Germany
GWT-Tud GmbH Coswig Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Toulouse Toulouse France
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Assistance Publique Hopitaux De Paris Paris France
Hospices Civils De Lyon Lyon France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Servei De Salut De Les Illes Balears Palma Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Hospital Universitario Virgen De Las Nieves Granada Spain
Multimedica S.p.A. Milan Italy
Odense University Hospital Odense Denmark
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hôpital Pontchaillou-CHU Rennes Rennes France
Assistance Publique Hopitaux De Paris Creteil France
Hospital Universitario Virgen De La Victoria Malaga Spain
Ospedale “Morgagni – Pierantoni” di Forlì Forli' Italy
Hcp Zpvldtftbakfnijgq Akoyxsltv Antwerp Belgium
Oupqggiamgaurykoncsuhkimaw Aalst Belgium
Cuuizhzni Uzudpyivdncgay Srcmrjpcy Woluwe-Saint-Lambert Belgium
Azvnwckvrn Pgkjnmjs Hbctyidq Dh Malewrfjc Marseille France
Ellvzha Uxnogiknpfnn Msudrkl Cfgmbxp Rgzlfkgmd (zrblyzc Miz Rotterdam The Netherlands
Ancpeup Ohnflqiwnfd Ulifqjgzbhpcz Sgqkun Siena Italy
Asscxk Uroauxjqfn Hxocjlpe Aarhus Denmark
Cwuaak Hxgkaisrtqj Rxpuxyhr Uiqlaluahtbby Dc Tuqbe Tours France
Kgoiijac dpd Utxlceysbwri Mmkwycnk Avk Munich Germany
Crzgdp Hnmcyugrmbr Uoxoherpgkbhn Rkvkw Reims France
Htzjbzee Umaebcsmwxteq Dz Lf Pcbsyhtq Madrid Spain
Hicitdhz Uuqyaidhhvljt Mojinjg Dx Vvksgvzgkl Santander Spain
Hvjnryvr Vvlv ddckuuku 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
Recruiting
25.01.2024
Denmark Denmark
Not recruiting
25.01.2024
France France
Recruiting
25.01.2024
Germany Germany
Recruiting
25.01.2024
Italy Italy
Recruiting
25.01.2024
Spain Spain
Recruiting
25.01.2024
The Netherlands The Netherlands
Not recruiting
25.01.2024

Trial locations

Investigated drugs:

Treprostinil is a medication used in this clinical trial to help manage fibrotic lung diseases. It is administered through inhalation, which means it is breathed directly into the lungs. The main goal of using this medication in the trial is to assess its long-term safety and how well patients can tolerate it. Treprostinil works by helping to improve blood flow in the lungs, which can help reduce symptoms and improve breathing in patients with conditions like idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).

Fibrotic Lung Disease – This condition involves the thickening and scarring of lung tissue, which can lead to a gradual decline in lung function. The disease often starts with symptoms like shortness of breath and a persistent dry cough. Over time, the scarring can make it increasingly difficult for the lungs to transfer oxygen into the bloodstream. As the disease progresses, individuals may experience fatigue, unexplained weight loss, and clubbing of the fingers. The exact cause of the fibrosis can vary, and in some cases, it may be linked to environmental factors or other underlying health conditions. The progression of the disease can vary significantly from person to person.

Trial ID:
2023-504471-25-00
Protocol code:
RIN-PF-302
NCT ID:
NCT04905693
Trial Phase:
Therapeutic confirmatory (Phase III)

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