Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Inhaled drug shows promise for managing tough Lung-Heart condition

NCT ID NCT05649722

Disease control Sponsor: Insmed Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of an inhaled medication called treprostinil palmitil (TPIP) for people with pulmonary hypertension caused by interstitial lung disease. Thirty-one adults who completed a previous study took part. The main goal was to check for side effects over time, not to cure the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

31 people

The number who actually took part.

Started

May 2023

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants who completed the end of treatment visit in Study INS1009-211 (NCT05176951). Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit. * Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-211, or any other lead-in PH-ILD TPIP study. * Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: * Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an unreasonable risk for the participant. * Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of Study INS1009-211 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE \[Tyvaso\] or iloprost) and oral prostacyclin analogues (eg, TRE \[Orenitram\]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration. Pregnant or breastfeeding. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug. \- Any medical or psychological condition, including relevant laboratory abnormalities at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Interstitial lung disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

interstitial lung disease pulmonary hypertension pulmonary hypertension owing to lung disease and/or hypoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Interstitial lung disease Pulmonary hypertension

Contacts and locations

Locations

  • ARG001

    Rosario, Santa Fe Province, S2013KDS, Argentina

  • ARG003

    Autonomus City of Buenos Aires, Buenos Aires, C1280AEB, Argentina

  • AUS005

    Macquarie Park, New South Wales, 2109, Australia

  • BEL002

    Liège, 4000, Belgium

  • ESP003

    Palma, Balearic Islands, 07120, Spain

  • ESP005

    Barcelona, 08907, Spain

  • ESP007

    Oviedo, Principality of Asturias, 33011, Spain

  • ESP009

    Santiago de Compostela, Galicia, 15706, Spain

  • ESP010

    Barcelona, 8035, Spain

  • GBR001

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • GBR003

    Clydebank, Glasgow, G81 4DY, United Kingdom

  • GER001

    Dresden, Saxony, 01307, Germany

  • GER002

    Berlin, 13125, Germany

  • GER003

    Essen, North Rhine-Westphalia, 45239, Germany

  • GER004

    München, Bavaria, 81377, Germany

  • GER006

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • GER010

    Giessen, Hesse, 35392, Germany

  • GER012

    Berlin, 14050, Germany

  • ITA001

    Palermo, Sicily, 90127, Italy

  • ITA002

    Monza, Lombardy, 20900, Italy

  • ITA003

    Naples, 80131, Italy

  • ITA004

    Milan, Lombardy, 20123, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.