Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: United Therapeutics
• Treatments: Treprostinil

Criteria

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.