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Clinical Trials in the USA / NCT04905693
Enrolling by invitation Phase 3

Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

NCT04905693 · tracked via the Priya Life Science USA tracker
Sponsor
United Therapeutics
Phase
Phase 3
Started
2022-09-06
Last updated
2026-09-03

Condition(s) studied

Idiopathic Pulmonary FibrosisInterstitial Lung DiseaseProgressive Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

Inhaled TreprostinilTreprostinil Ultrasonic Nebulizer

Inhaled Treprostinil: Inhaled Treprostinil (6 mcg/breath) administered QID

Treprostinil Ultrasonic Nebulizer: Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Subject gives voluntary informed consent to participate in the study. 2. 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. 3. 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. 4. 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. 5. 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. Exclusion Criteria: 1. Subject is pregnant or lactating. 2. In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health. 3. 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.

Primary outcome measure(s)

Trial sites (193)

FacilityCityRegionStatus
The University of Alabama at Birmingham Birmingham Alabama
Clinical Trials Center of Middle Tennessee Franklin Arizona
Banner University Medical Center-Phoenix Phoenix Arizona
St. Joseph's Hospital and Medical Center - Norton Thoracic Institute Phoenix Arizona
University of Arizona Tucson Arizona
UC San Diego Health La Jolla California
David Geffen School of Medicine at UCLA Los Angeles California
NewportNativeMD, Inc Newport Beach California
Palmtree Clinical Research, Inc. Palm Springs California
UC Davis Health Medical Center Sacramento California
University of California San Francisco San Francisco California
Stanford University School of Medicine Stanford California
National Jewish Health Denver Colorado
University of Florida Health at Shands Gainesville Florida
Ascension St. Vincent's Jacksonville Florida
Mayo Clinic Florida Jacksonville Florida
Pulmonary Disease Specialists, PA d/b/a PDS Research Kissimmee Florida
Central Florida Pulmonary Group, PA Orlando Florida
Coastal Pulmonary & Critical Care PLC St. Petersburg Florida
University of South Florida Health Tampa Florida
Cleveland Clinic Florida Weston Florida
Piedmont Healthcare Atlanta Atlanta Georgia
Emory University Atlanta Georgia
Northwestern Memorial Hospital Chicago Illinois
Loyola University Medical Center Maywood Illinois
Community Health Network Indianapolis Indiana
University of Kansas Medical Center Kansas City Kansas
Norton Pulmonary Specialists Louisville Kentucky
University of Louisville Healthcare Outpatient Center Louisville Kentucky
Tulane University Medical Center New Orleans Louisiana
LSU Health Science Center Shreveport Shreveport Louisiana
Johns Hopkins Asthma and Allergy Center Baltimore Maryland
Adventist Healthcare White Oak Medical Center Silver Spring Maryland
Tufts Medical Center Boston Massachusetts
Massachusetts General Hospital Boston Massachusetts
Brigham and Women's Hospital Boston Massachusetts
University of Michigan Int Med Pulmonary and critical care Ann Arbor Michigan
Corewell Health William Beaumont Hospital Royal Oak Michigan
University of Minnesota Minneapolis Minnesota
Mayo Clinic, Division of Pulmonary and Critical Care Medicine Rochester Minnesota

+ 153 more sites — see the full list on the official registry below.

More United Therapeutics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04905693 on ClinicalTrials.gov ↗ ← All trials in the USA