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 range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.