Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension (NCT03814317) | Clinical Trial Compass
CompletedPhase 2
Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension
United States5 participantsStarted 2020-01-30
Plain-language summary
This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.
Who can participate
Age range18 Years – 99 Years
SexALL
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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.