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New hope for sarcoidosis patients: inhaled drug targets lung and heart strain

NCT ID NCT03814317

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an inhaled medication called treprostinil in 5 people with sarcoidosis who also have lung scarring and high blood pressure in the lungs. The goal was to see if the drug could improve blood flow and heart function. Participants took the drug and were monitored with heart tests, walking tests, and breathing tests over time.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

5 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 99 years

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: * Study participant willing and able to provide informed consent * Negative urine pregnancy test at baseline for females of childbearing potential * Established diagnosis of sarcoidosis by ATS/ERS/WASOG 1999 Statement on of Sarcoidosis * Presence of interstitial lung disease by Scadding Stage IV chest radiograph or extensive fibrosis on chest computed tomography * Right heart catheterization within six months of baseline visit showing precapillary pulmonary hypertension (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg, and PVR \> 3 WU) * Patient on stable sarcoidosis therapy for at least three months prior to screening * If patients are on oral PAH therapy (PDE5i/SCGS and/or ERA) then dose should be stable for at least three months prior to screening * A 6MWT within three months of screening visit of \> 100 meters Exclusion Criteria: * Pregnant patients or those who are actively lactating * Patient not willing to use form of birth control (if applicable) during the study * Inability to undergo 6MWT, RHC, PFTs or CMRI * Predicted survival \< 6 months * Patient on any prostanoid or prostanoid analog therapy * Patients with left sided heart disease as defined by either a PCWP \> 15 mmHg and/or left ventricular ejection fraction \< 40% * Use of any investigational drug/device, or participation in any investigational study with therapeutic intent within 30 days prior to randomization.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Florida, Division of Pulmonary and Critical Care Medicine

    Gainesville, Florida, 32610, United States

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