Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension
Completed · Phase 2
Conditions studied: Sarcoidosis, Precapillary Pulmonary Hypertension, Interstitial Lung Disease
In brief
This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.
Key facts
- Study ID
- NCT03814317
- Run by
- University of Florida
- People needed
- 5
- Starts
- 2020-01-30
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2026-02-06
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Florida, Division of Pulmonary and Critical Care Medicine — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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