Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)

Stopped early · Phase 3

Conditions studied: Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

In brief

This open-label study will evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blind, adaptive study 'A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)(RIN-PH-304).

Key facts

Study ID

NCT03794583

Run by

United Therapeutics

People needed

41

Starts

2018-12-21

Expected to finish

2022-11-29

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant voluntarily gives informed consent to participate in the study.
• Participant completed Study RIN-PH-304.
• Women of childbearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must agree to practice abstinence or use 2 highly effective methods of contraception (defined as a method of birth control that results in a low failure rate, [less than 1% per year], such as approved hormonal contraceptives, barrier methods [such as condom or diaphragm] used with a spermicide, or an intrauterine device) for the duration of study treatment and for 48 hours after discontinuing study drug.
• Males with a partner of childbearing potential must agree to use a barrier method (condom) with a spermicide for the duration of treatment and for at least 48 hours after discontinuing study drug.

You may not qualify if…

• The participant is pregnant or lactating.
• The participant was prematurely discontinued from Study RIN-PH-304.
• The participant is intolerant to inhaled prostanoid therapy.
• The participant is unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device).
• The participant is scheduled to receive another investigational drug, device, or therapy during the course of this study.
• Any other clinically significant illness or abnormal laboratory value(s) that, in the opinion of the Investigator, might adversely affect the interpretation of the study data.

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California Davis Medical Center — Sacramento, California, United States
• St. Francis Sleep Allergy & Lung Institute — Clearwater, Florida, United States
• St. Vincent's Lung, Sleep, and Criticial Care Specialists — Jacksonville, Florida, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• University of Miami Hospital — Miami, Florida, United States
• Pulmonary & Critical Care of Atlanta — Atlanta, Georgia, United States
• Georgia Clinical Research — Austell, Georgia, United States
• University of Illinois Medical Center — Chicago, Illinois, United States
• St. Vincent Medical Group, Inc. — Indianapolis, Indiana, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Memorial Hospital at Gulfport — Gulfport, Mississippi, United States
• Albany Medical Center — Albany, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• The Carl and Edyth Lindner Research Center at The Christ Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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