Inhaled treprostinil for treating pulmonary hypertension in sarcoidosis patients
An Open-Label Study of Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension and Interstitial Lung Disease (SAPPHIRE)
This study is testing if inhaled treprostinil can help people with pulmonary hypertension caused by sarcoidosis breathe better and improve their exercise ability.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT03814317 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of inhaled treprostinil in patients with pulmonary hypertension associated with sarcoidosis-related interstitial lung disease. It targets a unique population that may benefit from this therapy while minimizing side effects linked to systemic treatments. The study involves administering inhaled treprostinil and monitoring its effects on pulmonary vascular resistance and exercise capacity over a 12-week period. Participants will undergo right heart catheterization to confirm their condition before enrollment.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with sarcoidosis who also have interstitial lung disease and precapillary pulmonary hypertension.
Not a fit: Patients who are pregnant, lactating, or unable to comply with study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve exercise capacity and overall quality of life for patients with sarcoidosis-associated pulmonary hypertension.
How similar studies have performed: Previous studies have shown inhaled treprostinil to be effective in other forms of pulmonary hypertension, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- University of Florida, Division of Pulmonary and Critical Care Medicine — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Ali Ataya, MD — University of Florida
- Study coordinator: Christina M Eagan, DNP
- Email: christina.eagan@medicine.ufl.edu
- Phone: 352-273-8990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.