Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension

Launched by UNIVERSITY OF FLORIDA · Jan 22, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called inhaled treprostinil in patients who have sarcoidosis-related lung disease and a specific type of high blood pressure in the lungs, known as precapillary pulmonary hypertension. The goal is to see if this treatment is both effective and safe for improving the health of these patients.

To participate in this trial, you need to be between the ages of 18 and 75 and have a confirmed diagnosis of sarcoidosis, along with significant lung issues. You'll also need to have had tests showing elevated pressure in your lungs. If you are eligible and decide to join, you can expect to undergo various assessments to monitor your health, and you'll need to be on stable medication for your sarcoidosis for at least three months before starting the trial. It's important to know that pregnant women or those who are breastfeeding cannot participate, and you must agree to use birth control if applicable. Overall, this study aims to find new ways to help people manage their symptoms and improve their quality of life.

Gender

ALL

Eligibility 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.