Status:
TERMINATED
Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
Lead Sponsor:
United Therapeutics
Collaborating Sponsors:
Lung Biotechnology PBC
Conditions:
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
This is a multi-center, open-label study for eligible participants who completed all scheduled study visits during the Treatment Period of Study RIN-PH-304. Participants who provide informed consent ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03794583
Start Date
December 21 2018
End Date
November 29 2022
Last Update
December 11 2025
Active Locations (31)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of California Davis Medical Center
Sacramento, California, United States, 95817
3
St. Francis Sleep Allergy & Lung Institute
Clearwater, Florida, United States, 33765
4
St. Vincent's Lung, Sleep, and Criticial Care Specialists
Jacksonville, Florida, United States, 32204