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Pulmonary HypertensionPhase 2/3NCT02633293

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

A Phase 2/3 study testing Inhaled Treprostinil in people with Pulmonary Hypertension and Interstitial Lung Disease, run by United Therapeutics at 92 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Inhaled Treprostinil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
92 sitesin 2 countries
Study dates
15 Sep 2016to 1 Aug 2021
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject voluntarily gives informed consent to participate in the study.
  • 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.
  • 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.
  • Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.

Who cannot join

  • The subject is pregnant or lactating.
  • The subject was prematurely discontinued from study RIN-PH-201.
  • 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.

Trial locations and contacts

92 sites in 2 countries.

92 sites in 2 countries

United States91 sites

  • Albany Medical College

    Albany, New York, 12208

  • The University of New Mexico

    Albuquerque, New Mexico, 87131

  • AnMed Health Pulmonary and Sleep Medicine

    Anderson, South Carolina, 29621

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • University of Colorado Hospital - Cardiac and Vascular Center

    Aurora, Colorado, 80045

  • Piedmont - Georgia Lung Associates

    Austell, Georgia, 30106

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Cedars-Sinai Medical Center

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Florida Lung, Asthma & Sleep Specialists, P.A.

    Celebration, Florida, 34747

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago Hospital

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The Carl and Edyth Lindner Research Center at The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati Health

    Cincinnati, Ohio, 45267

  • St. Francis Sleep, Allergy and Lung Institute

    Clearwater, Florida, 33765

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Vermont, Vermont Lung Center

    Colchester, Vermont, 05446

  • The Ohio State University Medical Center

    Columbus, Ohio, 43221

  • Baylor University Medical Center at Dallas

    Dallas, Texas, 75246

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22042

  • University of California, San Francisco-Fresno

    Fresno, California, 93701

  • University of Florida Clinical Research Center

    Gainesville, Florida, 32610

  • Spectrum Health Medical Center

    Grand Rapids, Michigan, 49503

  • Houston Methodist

    Houston, Texas, 77030

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Indiana University Hospital

    Indianapolis, Indiana, 46202

  • Community Heart and Vascular Hospital

    Indianapolis, Indiana, 46250

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Florida College of Medicine, Jacksonville

    Jacksonville, Florida, 32209

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • St. Vincent's Lung, Sleep, and Critical Care Specialists

    Jacksonville, Florida, 33204

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Statcare Pulmonary Consultants

    Knoxville, Tennessee, 37919

  • University of California San Diego

    La Jolla, California, 92093

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • University of Southern California

    Los Angeles, California, 90033

  • Department of Veterans Affairs Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • University of Louisville Physicians Outpatient Center

    Louisville, Kentucky, 40202

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53792

  • Wellstar Medical Group

    Marietta, Georgia, 30060

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami

    Miami, Florida, 33136

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin/Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • IMC-Diagnostic & Medical Clinic

    Mobile, Alabama, 36604

  • Northwell Health

    New Hyde Park, New York, 11040

  • Louisiana State University Health Sciences Center New Orleans

    New Orleans, Louisiana, 70112

  • NYU Langone Medical Center

    New York, New York, 10016

  • The Mount Sinai Hospital

    New York, New York, 10029

  • Weill Cornell Medical Center

    New York, New York, 10065

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Florida Hospital

    Orlando, Florida, 32804

  • Hospital of University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Arizona Pulmonary Specialists, Ltd.

    Phoenix, Arizona, 85012

  • Pinehurst Medical Clinic, Inc.

    Pinehurst, North Carolina, 28374

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Pulmonary Associates of Richmond

    Richmond, Virginia, 23229

  • Pacific Pulmonary Medical Group

    Riverside, California, 92505

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Kaiser Permanente

    San Francisco, California, 94115

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Maine Medical Center

    South Portland, Maine, 04106

  • Washington University Hospital

    St Louis, Missouri, 63110

  • University of South Florida

    Tampa, Florida, 33606

  • University of Arizona

    Tucson, Arizona, 85724

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • MedStar Heart & Vascular Institute

    Washington D.C., District of Columbia, 20010

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

Puerto Rico1 site

  • Alliance Cardio Pulmonary Research Group, Inc.

    Guaynabo, 00968

Other trials in Puerto Rico

About this study

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

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).

Being tested
Inhaled Treprostinil
Keywords
Treprostinil, PH, ILD, CPFE, 6 Minute Walk Test
Medical subject headings
Hypertension, Pulmonary, Lung Diseases, Interstitial, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled TreprostinilDrug

    Also called Tyvaso

    Inhaled treprostinil up to 15 breaths (90 mcg) four times daily

Study groups in NCT02633293
Study groupRoleWhat they receive
Inhaled TreprostinilExperimentalOpen-label access
Receives: Drug: Inhaled Treprostinil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (2)

  1. 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).

    Measured: 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)

  2. 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.

    Measured: Baseline and Weeks 12, 48, and 108

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2015 (estimated)
  2. Study start15 Sep 2016
  3. Primary completion1 Aug 2021
  4. Study completion1 Aug 2021

Why it stopped: Inhaled treprostinil became commercially available in the US following its approval for PH-ILD

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02633293
Sponsor's protocol ID
RIN-PH-202
Status last verified
Nov 2022
First submitted
11 Dec 2015
Last updated
2 Dec 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Inhaled Treprostinil in people with Pulmonary Hypertension and Interstitial Lung Disease, run by United Therapeutics at 92 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Peak 6-Minute Walk Distance (6MWD) From Baseline (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02633293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022; AzTrials last refreshed its copy on 1 Nov 2026.

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