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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03794583
Other study ID # RIN-PH-305
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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