Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
NCT ID: NCT03794583
Last Updated: 2025-12-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
41 participants
INTERVENTIONAL
2018-12-21
2022-11-29
Brief Summary
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Detailed Description
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Participants who provide informed consent for this open-label extension study on or prior to the final study visit of RIN-PH-304 may participate in the study, provided all other eligibility criteria are met. The RIN-PH-304 final study visit and the RIN-PH-305 Enrollment Visit will occur on the same day.
All participants will reinitiate inhaled treprostinil at 3 breathes (18 micrograms \[mcg\]) 4 times daily (QID) during waking hours. Study drug doses should be maximized to tolerability throughout the study, and dose titrations should occur as rapidly as possible (as directed by the Investigator) with a target dosing regimen of 15 breaths QID or the maximum tolerated dose.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Inhaled Treprostinil Solution
Inhaled treprostinil solution (0.6 milligrams per milliliter \[mg/mL\], 6 mcg/breath) QID during waking hours.
Inhaled treprostinil solution
Inhaled treprostinil solution per dose and schedule specified in the arm
Interventions
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Inhaled treprostinil solution
Inhaled treprostinil solution per dose and schedule specified in the arm
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Lung Biotechnology PBC
INDUSTRY
Responsible Party
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Locations
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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
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
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
Carilion Clinic
Roanoke, Virginia, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Lady Davis Carmel Medical Centre
Haifa, , Israel
Hadassah-Hebrew University Hospital
Jerusalem, , Israel
Rabin Medical Center
Petah Tiva, , Israel
"Azienda Unita Sanitaria Locale Della Romagna Ospedale ""Gian Battista Morgagni"" - Luigi Pierantoni"" di Forli"
Forlì, Forli, Italy
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RIN-PH-305
Identifier Type: -
Identifier Source: org_study_id
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