A study to evaluate the safety and effectiveness of inhaled treprostinil in patients with pulmonary hypertension associated with interstitial lung disease

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What is this study about?

This study is being conducted to evaluate the safety and effectiveness of a new inhaled medication called L606, which contains treprostinil liposome, for people living with Pulmonary Hypertension associated with Interstitial Lung Disease. This condition is a type of high blood pressure in the lungs that occurs in individuals who also have scarring or inflammation of the lung tissue. The treatment is delivered through inhalation, which means the medication is breathed in through the lungs.

Participants in the study will be assigned to receive either L606 or a placebo. This research involves a randomized and double-blind process, meaning that neither the participants nor the researchers know which specific treatment is being administered until the study is finished. The study will monitor how the medication affects the ability to walk and other health factors over a period of time.

Who Can Join the Study?

  • You must be between 18 and 80 years old.
  • You must have a confirmed diagnosis of interstitial lung disease (ILD), which is a condition where scarring or inflammation makes it difficult for the lungs to work properly, as seen on a special detailed chest scan called a High Resolution Computed Tomography (HRCT).
  • You must show signs of pulmonary hypertension, which is high blood pressure in the arteries of the lungs, confirmed through a procedure called Right Heart Catheterization (RHC) where a thin tube is used to measure pressure in the heart.
  • Your pulmonary vascular resistance (PVR), which measures how much force is needed to push blood through the lung vessels, must be 320 dynes.sec/cm5 or higher.
  • Your mean Pulmonary Artery Pressure (mPAP), which is the average amount of pressure in the main artery of the lungs, must be 25 mmHg or higher.
  • Your pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP), which are measurements used to check the pressure inside the left side of the heart, must be 15 mmHg or lower.
  • Your FEV1/FVC ratio, which is a calculation used to check how much air you can breathe out quickly compared to the total amount of air you can hold, must be greater than 0.70.
  • You must be able to walk at least 150 meters during a six-minute walk test, which is a test used to measure how much exercise you can handle.

Who Cannot Join the Study?

  • You cannot participate if your pulmonary hypertension (high blood pressure in the lung arteries) is categorized into other specific groups (Groups 1, 2, 4, or 5) according to the official medical classification.
  • You cannot participate if an echocardiogram (an ultrasound used to look at the heart) shows significant problems with the left side of your heart.
  • You cannot participate if you have a history of atrial fibrillation (an irregular or uneven heartbeat) that is constant or cannot be controlled with medicine.
  • You cannot participate if you have severe obstructive sleep apnea (a condition where your breathing repeatedly stops and starts while you are sleeping).
  • You cannot participate if you have recently had a sudden worsening of your lung condition or an active lung infection that requires antibiotics (medicine used to kill bacteria).
  • You cannot participate if you have recently started pulmonary rehabilitation (a specialized program of exercise and education designed to help people with lung disease).
  • You cannot participate if you have severe coronary heart disease (serious damage to the blood vessels that supply the heart), unstable angina (chest pain that is unpredictable or worsening), or have had a myocardial infarction (a heart attack) within the last 180 days.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Unidade Local De Saude De Almada-Seixal E.P.E. Almada Portugal
Universitair Ziekenhuis Gent Gent Belgium
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie Lublin Poland
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Justus-Liebig-Universitaet Giessen Giessen Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. Palermo Italy
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Krankenhaus Neuwittelsbach Munich Germany
Uvidkrhpeb Msvyryg Cqtwka Hgprejitmhvppsknn Hamburg Germany
Oqgaxtepsxkdrl Lcnr Gtud Linz Austria
Hgdbpyif Ufzksgqlsmnaa Mkfebhj Dy Vlxbywcvmm Santander Spain
Ueiefchkmc Hjpubqih Cnggjla Cologne Germany
Aqlidcmbis Plxcdbmm Hoydefui Du Mvdbqegda Marseille France
Cehd Dm Nvufn Vandoeuvre Les Nancy France
Kgbfjuny dep Ukfytsefvhnk Mewfvuth Ayk Munich Germany
Umnqyehxop Dolbs Sekzc Dm Ryun Ln Sugeenfu Rome Italy
Huvlhxnh Vbxr digisqls Barcelona Spain
Kutuimncd Slulvcy Shkqchkkqjgmiqn in Jgoe Picki Ir Cracow Poland
Hsupedma Utlrjccpvmzsfr Stooasbugo &qlwagf Hfoikxf dv Hacqgtfchvp STRASBOURG, Alsace France
Csakvw Hiwnksqrvm E Umpbqzgznjgcg Do Cnombzc Ewwxel Coimbra Portugal

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

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.05.2026
Belgium Belgium
Not yet recruiting
01.05.2026
Czechia Czechia
Not yet recruiting
01.05.2026
France France
Recruiting
01.05.2026
Germany Germany
Recruiting
01.05.2026
Italy Italy
Not yet recruiting
01.05.2026
Latvia Latvia
Recruiting
01.05.2026
Poland Poland
Not yet recruiting
01.05.2026
Portugal Portugal
Not yet recruiting
01.05.2026
Spain Spain
Recruiting
01.05.2026

Trial locations

Investigated drugs:

Treprostinil is an inhaled medication used to treat pulmonary hypertension, a condition where the blood pressure in the lungs is too high. In this study, it is delivered as an inhalation powder or solution to help improve how well a person can walk and to manage the symptoms of high blood pressure in the lungs associated with lung disease.

Pulmonary hypertension associated with interstitial lung disease – This condition occurs when there is high blood pressure in the arteries of the lungs caused by underlying lung tissue damage. The interstitial lung disease causes scarring or inflammation within the lung tissue, making it difficult for the lungs to expand and transfer oxygen. As the lung tissue becomes stiffer, the blood vessels in the lungs are compressed or damaged. This resistance forces the heart to work harder to pump blood through the lungs. Over time, the increased pressure in the lung arteries can lead to further changes in the blood vessels. The condition typically progresses as the lung damage and vascular resistance increase.

Trial ID:
2024-517943-29-00
Protocol code:
L606-301
Trial Phase:
Therapeutic confirmatory (Phase III)

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