Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

Enrolling by invitation · Phase 3

Conditions studied: Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Progressive Pulmonary Fibrosis

In brief

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.

Key facts

Study ID

NCT04905693

Run by

United Therapeutics

People needed

1850

Starts

2022-09-06

Expected to finish

2029-12-01

Last updated by the study team

2026-07-28

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject gives voluntary informed consent to participate in the study.
• The subject participated in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 at the time that the study or study subject was discontinued by the Sponsor for reasons other than safety.
• Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit) and non-lactating, and will agree to abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
• Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
• In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

You may not qualify if…

• Subject is pregnant or lactating.
• In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.
• Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement). Subjects participating in non-interventional, observational, or registry studies are eligible.

Where it is running

• Clinical Trials Center of Middle Tennessee — Franklin, Arizona, United States
• Banner University Medical Center-Phoenix — Phoenix, Arizona, United States
• St. Joseph's Hospital and Medical Center - Norton Thoracic Institute — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• UC San Diego Health — La Jolla, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• NewportNativeMD, Inc — Newport Beach, California, United States
• Palmtree Clinical Research, Inc. — Palm Springs, California, United States
• UC Davis Health Medical Center — Sacramento, California, United States
• University of California San Francisco — San Francisco, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• National Jewish Health — Denver, Colorado, United States
• University of Florida Health at Shands — Gainesville, Florida, United States
• Ascension St. Vincent's — Jacksonville, Florida, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Pulmonary Disease Specialists, PA d/b/a PDS Research — Kissimmee, Florida, United States
• Central Florida Pulmonary Group, PA — Orlando, Florida, United States
• Coastal Pulmonary & Critical Care PLC — St. Petersburg, Florida, United States
• University of South Florida Health — Tampa, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Piedmont Healthcare Atlanta — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• The University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.