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

Chronic Obstructive Pulmonary Disease Clinical Trial

— PERFECT OLE  

Official title:

An Open-Label Extension Study of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03794583
• Other study ID #: RIN-PH-305
• Status: Terminated
• Phase: Phase 3
• Start date: December 21, 2018
• Est. completion date: November 29, 2022

Study information

• Verified date: November 2023
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Hypertension

Intervention

Drug:
• Inhaled treprostinil solution
Inhaled treprostinil solution per dose and schedule specified in the arm

Locations

Country	Name	City	State
Israel	Lady Davis Carmel Medical Centre	Haifa
Israel	Hadassah-Hebrew University Hospital	Jerusalem
Israel	Rabin Medical Center	Petah Tiva
United States	Albany Medical Center	Albany	New York
United States	Pulmonary & Critical Care of Atlanta	Atlanta	Georgia
United States	Georgia Clinical Research	Austell	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
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	University of Illinois Medical Center	Chicago	Illinois
United States	The Carl and Edyth Lindner Research Center at The Christ Hospital	Cincinnati	Ohio
United States	St. Francis Sleep Allergy & Lung Institute	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Spectrum Health	Grand Rapids	Michigan
United States	St. Vincent Medical Group, Inc.	Indianapolis	Indiana
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	St. Vincent's Lung, Sleep, and Criticial Care Specialists	Jacksonville	Florida
United States	Kentuckiana Pulmonary Associates	Louisville	Kentucky
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	University of Miami Hospital	Miami	Florida
United States	Mount Sinai Medical Center	New York	New York
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Pulmonary Associates of Richmond, Inc.	Richmond	Virginia
United States	Carilion Clinic	Roanoke	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
United Therapeutics	Lung Biotechnology PBC

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	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.	Up to 4 years
Secondary	Change From Baseline to Week 6 in 6-Minute Walk Distance (6MWD)	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.	Baseline, Week 6
Secondary	Change From Baseline to Week 6 in Borg Dyspnea Score	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.	Baseline, Week 6
Secondary	Change From Baseline to Week 6 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)	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.	Baseline, Week 6