Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension
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
🗓️ Study Start (Actual) 30 January 2020
🗓️ Primary Completion (Estimated) 30 January 2025
✅ Study Completion (Estimated) 29 July 2025
👥 Enrollment (Estimated) 10
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Gainesville, Florida, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 99 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 January 2019
  • First Submitted that Met QC Criteria 22 January 2019
  • First Posted 24 January 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 May 2024
  • Last Update Posted 28 May 2024
  • Last Verified May 2024