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

Phase 3

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
• Interventions: Drug: Inhaled treprostinil solution

• Registration Number: NCT03794583
• Lead Sponsor: United Therapeutics

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 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).

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 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.

Study Timeline

• Study Start: 2018-12-21
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Primary Completion: 2022-11-29
• Study Completion: 2022-11-29
• Status Verified: 2023-11
• Results First Submitted: 2023-11-27
• Results First Submitted QC: 2023-11-27
• Last Update Submitted: 2023-11-27
• Results First Posted: 2023-12-18
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inhaled Treprostinil Solution	Inhaled treprostinil solution	Inhaled treprostinil solution (0.6 milligrams per milliliter \[mg/mL\], 6 mcg/breath) QID during waking hours.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Up to 4 years	An adverse event (AE) can be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent was defined as any AE occurring/worsening at any time after a participant was exposed to study drug up until 7 days after the last dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 6 in Borg Dyspnea Score	Baseline, Week 6	The Borg Dyspnea Score was a 11-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (no dyspnea at all) to 10 (very, very severe dyspnea), with lower scores indicating less exertion (a better outcome). The Borg Dyspnea Score was to be evaluated immediately after the 6MWT.
Change From Baseline to Week 6 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)	Baseline, Week 6	The NT-proBNP concentration is a biomarker associated with changes in right heart morphology and function. Improvement is defined as a decrease in the NT-proBNP plasma concentration.
Change From Baseline to Week 6 in 6-Minute Walk Distance (6MWD)	Baseline, Week 6	6MWD was calculated at peak exposure (10 to 60 minutes after dosing). 6-minute walk test (6MWT) was performed by standardized procedures for all participants. Participants were asked to walk a set course for 6 minutes (timed) and the distance walked (in meters) was recorded.

Trial Locations

Locations (30)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Illinois Medical Center; 🇺🇸 Chicago, Illinois, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

St. Vincent's Lung, Sleep, and Criticial Care Specialists; 🇺🇸 Jacksonville, Florida, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Wisconsin School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States

St. Francis Sleep Allergy & Lung Institute; 🇺🇸 Clearwater, Florida, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Lady Davis Carmel Medical Centre; 🇮🇱 Haifa, Israel

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Rabin Medical Center; 🇮🇱 Petah Tiva, Israel

University of Miami Hospital; 🇺🇸 Miami, Florida, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

St. Vincent Medical Group, Inc.; 🇺🇸 Indianapolis, Indiana, United States

The Carl and Edyth Lindner Research Center at The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Georgia Clinical Research; 🇺🇸 Austell, Georgia, United States

Pulmonary & Critical Care of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States

Albany Medical Center; 🇺🇸 Albany, New York, United States

Carilion Clinic; 🇺🇸 Roanoke, Virginia, United States

Hadassah-Hebrew University Hospital; 🇮🇱 Jerusalem, Israel

Kentuckiana Pulmonary Associates; 🇺🇸 Louisville, Kentucky, United States

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Pulmonary Associates of Richmond, Inc.; 🇺🇸 Richmond, Virginia, United States