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

Primary Purpose

Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Inhaled treprostinil solution

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Treprostinil, Lung Diseases, Hypertension, Vascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

The University of Alabama at Birmingham
University of California Davis Medical Center
St. Francis Sleep Allergy & Lung Institute
St. Vincent's Lung, Sleep, and Criticial Care Specialists
Mayo Clinic - Jacksonville
University of Miami Hospital
Pulmonary & Critical Care of Atlanta
Georgia Clinical Research
University of Illinois Medical Center
St. Vincent Medical Group, Inc.
Kentuckiana Pulmonary Associates
University of Maryland Medical Center
Brigham and Women's Hospital
Spectrum Health
Albany Medical Center
Mount Sinai Medical Center
University of Rochester Medical Center
University of North Carolina at Chapel Hill
The Carl and Edyth Lindner Research Center at The Christ Hospital
Cleveland Clinic
Allegheny General Hospital
University of Pittsburgh Medical Center
Medical University of South Carolina
Inova Fairfax Hospital
Pulmonary Associates of Richmond, Inc.
Carilion Clinic
University of Wisconsin School of Medicine and Public Health
Lady Davis Carmel Medical Centre
Hadassah-Hebrew University Hospital
Rabin Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inhaled Treprostinil Solution

Arm Description

Inhaled treprostinil solution (0.6 milligrams per milliliter [mg/mL], 6 mcg/breath) QID during waking hours.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

6 Minute Walk Distance (6MWD)

Participants will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.

Borg Dyspnea Score

The modified 0-10 category-ratio Borg scale is one in which the participants rate the maximum level of dyspnea they experienced during the Six Minute Walk Test (6MWT). Scores range from 0 (for the best condition) and 10 (for the worst condition).

N-terminal Pro-brain Natriuretic Peptide (NT-pro-BNP)

The NT-proBNP concentration is a biomarker associated with changes in right heart morphology and function.

Saturation Peripheral Capillary Oxygenation (SpO2)

SpO2 will be assessed via pulse oximetry.

Heart Rate

Heart rate will be assessed via pulse oximetry

Change in Baseline in Patient Global Assessment (PGA)

The PGA is used to rate participant fatigue and shortness of breath. Participants will use the Sponsor-provided smart device for at-home capture of PGA data.

Change from Baseline in Actigraphy

Daily physical activity, including overall, non-sedentary, and moderate to vigorous physical activity will be measured via a wrist-worn medical grade physical activity monitor (actigraph).

Full Information

NCT ID

NCT03794583

First Posted

January 2, 2019

Last Updated

March 22, 2023

Sponsor

United Therapeutics

Collaborators

Lung Biotechnology PBC

1. Study Identification

Unique Protocol Identification Number

NCT03794583

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Terminated

Why Stopped

Sponsor's decision

Study Start Date

December 21, 2018 (Actual)

Primary Completion Date

November 29, 2022 (Actual)

Study Completion Date

November 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United Therapeutics

Collaborators

Lung Biotechnology PBC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

Keywords

Treprostinil, Lung Diseases, Hypertension, Vascular Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

This trial is not blinded. All participants will begin titration of study drug once all entry criteria have been met.

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inhaled Treprostinil Solution

Arm Type

Experimental

Arm Description

Inhaled treprostinil solution (0.6 milligrams per milliliter [mg/mL], 6 mcg/breath) QID during waking hours.

Intervention Type

Drug

Intervention Name(s)

Inhaled treprostinil solution

Intervention Description

Inhaled treprostinil solution per dose and schedule specified in the arm

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time Frame

From enrollment to end of study, estimated up to 2 years.

Secondary Outcome Measure Information:

Title

6 Minute Walk Distance (6MWD)

Description

Time Frame