Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
NCT ID: NCT04708782
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
576 participants
INTERVENTIONAL
2021-06-01
2026-01-31
Brief Summary
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Detailed Description
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Efficacy assessments include spirometry (FVC), time to clinical worsening, time to first acute exacerbation of IPF, overall survival, King's Brief Interstitial Lung Disease (K-BILD) questionnaire, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, supplemental oxygen use, and lung diffusion capacity (DLCO). Safety assessments include the development of adverse events (AEs)/serious adverse events (SAEs), vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters.
Subjects who complete the Week 52 Visit may be offered the opportunity to enter an open-label extension (OLE) study after completing the final study visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching placebo inhaled using an ultrasonic nebulizer QID
Placebo
Placebo administered QID
Treprostinil Ultrasonic Nebulizer
Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Inhaled Treprostinil
Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated up to a target of 12 breaths QID or until the subject reaches their maximum clinically tolerated dose.
Inhaled Treprostinil
Inhaled treprostinil (6 mcg/breath) administered QID
Treprostinil Ultrasonic Nebulizer
Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Interventions
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Placebo
Placebo administered QID
Inhaled Treprostinil
Inhaled treprostinil (6 mcg/breath) administered QID
Treprostinil Ultrasonic Nebulizer
Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 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
Centro Respiratorio Integral LTDA. (CENRESIN)
Quillota, Región de Valparaíso, Chile
Fundacion Medica San Cristobal
Santiago, Santiago Metropolitan, Chile
Countries
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Other Identifiers
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RIN-PF-301
Identifier Type: -
Identifier Source: org_study_id
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