New hope for sarcoidosis patients: inhaled drug targets lung and heart strain
NCT ID NCT03814317
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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Jan 2020
- Finished
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Dec 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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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Other studies related to the condition(s) this trial covers.
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