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Inhaled treprostinil safety trial for PH-COPD ends early

NCT ID NCT03794583

Disease control Sponsor: United Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of an inhaled drug called treprostinil in people who have both pulmonary hypertension (high blood pressure in the lungs) and COPD. It included 41 adults who had already completed a previous study. The trial was terminated early, and the main goal was to track side effects. Results may help understand if this treatment is safe to use over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inhaled treprostinil
What this could lead to
If successful, this could support the use of inhaled treprostinil as a safe long-term treatment for pulmonary hypertension related to COPD.
What could go wrong
The study was terminated early with only 41 participants, so results are limited. It was an open-label extension, meaning no placebo group for comparison, and safety data may not be conclusive.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

41 people

The number who actually took part.

Started

Dec 2018

Finished

Nov 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant voluntarily gives informed consent to participate in the study. 2. Participant completed Study RIN-PH-304. 3. 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. 4. 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. Exclusion Criteria: 1. The participant is pregnant or lactating. 2. The participant was prematurely discontinued from Study RIN-PH-304. 3. The participant is intolerant to inhaled prostanoid therapy. 4. The participant is unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device). 5. The participant is scheduled to receive another investigational drug, device, or therapy during the course of this study. 6. 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.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease hypertensive disorder lung disorder pulmonary hypertension pulmonary hypertension owing to lung disease and/or hypoxia vascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease Pulmonary hypertension

Contacts and locations

Locations

  • "Azienda Unita Sanitaria Locale Della Romagna Ospedale ""Gian Battista Morgagni"" - Luigi Pierantoni"" di Forli"

    Forlì, Forli, 47121, Italy

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Carilion Clinic

    Roanoke, Virginia, 24014, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Georgia Clinical Research

    Austell, Georgia, 30106, United States

  • Hadassah-Hebrew University Hospital

    Jerusalem, 9112001, Israel

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Kentuckiana Pulmonary Associates

    Louisville, Kentucky, 40202, United States

  • Lady Davis Carmel Medical Centre

    Haifa, 34362, Israel

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Hospital at Gulfport

    Gulfport, Mississippi, 39501, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Pulmonary & Critical Care of Atlanta

    Atlanta, Georgia, 30342, United States

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230, United States

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Spectrum Health

    Grand Rapids, Michigan, 49546, United States

  • St. Francis Sleep Allergy & Lung Institute

    Clearwater, Florida, 33765, United States

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana, 46260, United States

  • St. Vincent's Lung, Sleep, and Criticial Care Specialists

    Jacksonville, Florida, 32204, United States

  • The Carl and Edyth Lindner Research Center at The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Illinois Medical Center

    Chicago, Illinois, 60612, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Miami Hospital

    Miami, Florida, 33136, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Medical Center

    Rochester, New York, 14623, United States

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53792, United States

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