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NCT04708782

PHASE3

Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Sponsor: United Therapeutics

View on ClinicalTrials.gov

Summary

Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.

Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-1)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

598

Start Date

2021-06-01

Completion Date

2026-02-02

Last Updated

2026-05-05

Healthy Volunteers

Conditions

Idiopathic Pulmonary Fibrosis Interstitial Lung Disease

Interventions

DRUG

Placebo

Placebo administered QID

DRUG

Inhaled Treprostinil

Inhaled treprostinil (6 mcg/breath) administered QID

DEVICE

Treprostinil Ultrasonic Nebulizer

Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

Inclusion Criteria: 1. Subject gives voluntary informed consent to participate in the study. 2. Subject is ≥40 years of age, inclusive, at the time of signing informed consent. 3. The subject has a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu 2018) and confirmed by central review of high-resolution computed tomography (HRCT) (performed within the previous 12 months), and if available, surgical lung biopsy. 4. FVC ≥45% predicted at Screening. 5. Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for ≥30 days prior to Baseline. Concomitant use of both pirfenidone and nintedanib is not permitted. 6. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug. 7. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug. 8. In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits. Exclusion Criteria: 1. Subject is pregnant or lactating. 2. Subject has primary obstructive airway physiology: FEV1/FVC \<0.70 at Screening. 3. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy. 4. The subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5-Is), or soluble guanylate cyclase stimulators within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours of any study-related efficacy assessments. 5. Use of any of the following medications: azathioprine (AZA), cyclosporine, mycophenolate mofetil, tacrolimus, oral corticosteroids (OCS) \>20 mg/day or the combination of OCS+AZA+N-acetylcysteine within 30 days prior to Baseline; cyclophosphamide within 60 days prior to Baseline; or rituximab within 6 months prior to Baseline. 6. The subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline. 7. Exacerbation of IPF or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of IPF or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible. 8. Uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline. 9. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation. 10. Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Screening. Subjects participating in non-interventional, observational, or registry studies are eligible. 11. Life expectancy \<6 months due to IPF or a concomitant illness. 12. Acute pulmonary embolism within 90 days prior to Baseline.

Locations (98)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner University Medical Center-Phoenix

Phoenix, Arizona, United States

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, United States

St. Joseph's Hospital and Medical Center - Norton Thoracic Institute

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

UC San Diego Health

La Jolla, California, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

NewportNativeMD, Inc

Newport Beach, California, United States

University of California, Irvine

Orange, California, United States

Palmtree Clinical Research, Inc.

Palm Springs, California, United States

UC Davis Health Medical Center

Sacramento, California, United States

University of California - San Francisco

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

National Jewish Health

Denver, Colorado, United States

St. Francis Sleep Allergy & Lung Institute

Clearwater, Florida, United States

University of Florida Health at Shands

Gainesville, Florida, United States

Ascension St. Vincent's

Jacksonville, Florida, United States

University of Florida

Jacksonville, Florida, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Pulmonary Disease Specialists, PA d/b/a PDS Research

Kissimmee, Florida, United States

Central Florida Pulmonary Group, PA

Orlando, Florida, United States

Coastal Pulmonary & Critical Care PLC

St. Petersburg, Florida, United States

University of South Florida Health

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Piedmont Healthcare Atlanta

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Rush University Medical Center Outpatient Pulmonary Clinic

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Community Health Network

Indianapolis, Indiana, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

Norton Pulmonary Specialists

Louisville, Kentucky, United States

University of Louisville

Louisville, Kentucky, United States

LSU Health Sciences Center New Orleans

New Orleans, Louisiana, United States

Tulane University Medical Center

New Orleans, Louisiana, United States

LSU Health Science Center Shreveport

Shreveport, Louisiana, United States

Johns Hopkins Asthma & Allergy Center

Baltimore, Maryland, United States

Adventist Healthcare White Oak Medical CEnter

Silver Spring, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan Int Med Pulmonary and critical care

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Corewell Health William Beaumont Hospital

Royal Oak, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

The Lung Research Center

Chesterfield, Missouri, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Creighton University Clinical Research Office

Omaha, Nebraska, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

St Joseph's Physician's Pulmonary Health

Liverpool, New York, United States

Northwell Health

New Hyde Park, New York, United States

University of Rochester Medical center

Rochester, New York, United States

Stony Brook Advanced Specialty Care

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

PulmonIx, LLC

Greensboro, North Carolina, United States

East Carolina University and Leo Jenkins Cancer Center

Greenville, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

The Oregon Clinic, PC

Portland, Oregon, United States

Penn State Milton S. Hershey Medical Center/Penn State College of Medicine

Hershey, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thoams Jefferson,Hospital University

Philadelphia, Pennsylvania, United States

Temple Lung Center

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health Midlands

Columbia, South Carolina, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Statecare Pulmonary Consultants

Knoxville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

Univrsity of Texas Southwestern Medical Center

Dallas, Texas, United States

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, United States

Baylor Clinic-Baylor College of Medicine

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

A & A Research Consultants, LLC

McAllen, Texas, United States

Metroplex Pulmonary and Sleep Center PA

McKinney, Texas, United States

Renovatio Clinical Consultants, LLC

The Woodlands, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah Health

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, United States

University of Wisconsin School of Medicine and Public health

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

St.Paul's Hospital

Vancouver, British Columbia, Canada

Dynamic Drug Advancement Limited

Ajax, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Centre d'investigation Clinique Mauricie

Trois-Rivières, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite

Québec, Canada

Fundacion Medica San Cristobal

Santiago, Santiago Metropolitan, Chile

Centro Respiratorio Integral LTDA. (CENRESIN)

Quillota, Valparaiso, Chile

Clinical Research Directory

Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (98)