An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE

Pulmonary Hypertension Clinical Trial

Official title:

An Open-Label Extension Study of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02633293
• Other study ID #: RIN-PH-202
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 15, 2016
• Est. completion date: August 1, 2021

Study information

• Verified date: November 2022
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available for patients with PH associated with ILD including CPFE (whichever is sooner).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 243
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject voluntarily gives informed consent to participate in the study.

2. The subject participated in study RIN-PH-201, remained on study drug, was compliant with RIN-PH-201 study procedures or was enrolled in study RIN-PH-201 at the time that the study was discontinued by the sponsor.

3. Females of reproductive potential must be non-pregnant (as confirmed by a urine pregnancy test at Baseline) and non-lactating, and will:

• Either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or

• Use two medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug.

4. Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.

Exclusion Criteria:

1. The subject is pregnant or lactating.

2. The subject was prematurely discontinued from study RIN-PH-201.

3. The subject developed a concurrent illness or condition during the conduct of RIN-PH-201 which, in the opinion of the Investigator, would represent a risk to overall health if they enrolled in this study.

Related Conditions & MeSH terms

• Combined Pulmonary Fibrosis and Emphysema
• Emphysema
• Hypertension
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis
• Pulmonary Hypertension

Intervention

Drug:
• Inhaled Treprostinil
Inhaled treprostinil up to 15 breaths (90 mcg) four times daily

Locations

Country	Name	City	State
Puerto Rico	Alliance Cardio Pulmonary Research Group, Inc.	Guaynabo
United States	Albany Medical College	Albany	New York
United States	The University of New Mexico	Albuquerque	New Mexico
United States	AnMed Health Pulmonary and Sleep Medicine	Anderson	South Carolina
United States	The Emory Clinic	Atlanta	Georgia
United States	University of Colorado Hospital - Cardiac and Vascular Center	Aurora	Colorado
United States	Piedmont - Georgia Lung Associates	Austell	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Cedars-Sinai Medical Center	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	New York Methodist Hospital	Brooklyn	New York
United States	Florida Lung, Asthma & Sleep Specialists, P.A.	Celebration	Florida
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	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Illinois at Chicago Hospital	Chicago	Illinois
United States	The Carl and Edyth Lindner Research Center at The Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati Health	Cincinnati	Ohio
United States	St. Francis Sleep, Allergy and Lung Institute	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	University of Vermont, Vermont Lung Center	Colchester	Vermont
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Baylor University Medical Center at Dallas	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	Inova Fairfax Hospital	Fairfax	Virginia
United States	University of California, San Francisco-Fresno	Fresno	California
United States	University of Florida Clinical Research Center	Gainesville	Florida
United States	Spectrum Health Medical Center	Grand Rapids	Michigan
United States	Houston Methodist	Houston	Texas
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Community Heart and Vascular Hospital	Indianapolis	Indiana
United States	Indiana University Hospital	Indianapolis	Indiana
United States	St. Vincent Medical Group, Inc.	Indianapolis	Indiana
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	St. Vincent's Lung, Sleep, and Critical Care Specialists	Jacksonville	Florida
United States	University of Florida College of Medicine, Jacksonville	Jacksonville	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Statcare Pulmonary Consultants	Knoxville	Tennessee
United States	University of California San Diego	La Jolla	California
United States	VA Long Beach Healthcare System	Long Beach	California
United States	Department of Veterans Affairs Greater Los Angeles Healthcare System	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	University of Louisville Physicians Outpatient Center	Louisville	Kentucky
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	Wellstar Medical Group	Marietta	Georgia
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Miami	Miami	Florida
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Medical College of Wisconsin/Froedtert Hospital	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	IMC-Diagnostic & Medical Clinic	Mobile	Alabama
United States	Northwell Health	New Hyde Park	New York
United States	Louisiana State University Health Sciences Center New Orleans	New Orleans	Louisiana
United States	NYU Langone Medical Center	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Hospital of University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Pulmonary Specialists, Ltd.	Phoenix	Arizona
United States	Pinehurst Medical Clinic, Inc.	Pinehurst	North Carolina
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Pulmonary Associates of Richmond	Richmond	Virginia
United States	Pacific Pulmonary Medical Group	Riverside	California
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California Davis Medical Center	Sacramento	California
United States	Washington University Hospital	Saint Louis	Missouri
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Kaiser Permanente	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Maine Medical Center	South Portland	Maine
United States	University of South Florida	Tampa	Florida
United States	University of Arizona	Tucson	Arizona
United States	Georgetown University Hospital	Washington	District of Columbia
United States	MedStar Heart & Vascular Institute	Washington	District of Columbia
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak 6-Minute Walk Distance (6MWD) From Baseline	The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for 6 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. Peak exposure 6MWD will occur by conducting 6MWT within 10 to 60 minutes after the most recent dose of study drug dose.	Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202)
Secondary	Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline	The N-terminal pro-BNP (NT-proBNP) serum concentration is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and each visit through Week 124. Blood for NT-proBNP assessment must be drawn prior to conducting the 6-minute walk test (6MWT).	Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202)
Secondary	Change in Percent Predicted Forced Vital Capacity (FVC) From Baseline	Change in pulmonary function following inhaled treprostinil therapy will be measured by Forced Vital Capacity (FVC), calculated from a Pulmonary Function Test (PFT) performed at Baseline and Weeks 12, 48, and 108.	Baseline and Weeks 12, 48, and 108