Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension

Description

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

Conditions

Sarcoidosis, Precapillary Pulmonary Hypertension, Interstitial Lung Disease

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Study Overview

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Study Details

Study overview

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

An Open-Label Study of Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension and Interstitial Lung Disease (SAPPHIRE)

Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension

Condition
Sarcoidosis
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Division of Pulmonary and Critical Care Medicine, Gainesville, Florida, United States, 32610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Florida,

Ali Ataya, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

2025-07-29