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Inhaled treprostinil aims to slow IPF lung damage in major trial

NCT ID NCT04708782

Disease control Sponsor: United Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested whether an inhaled drug called treprostinil (Tyvaso) could slow the loss of lung function in 598 adults with idiopathic pulmonary fibrosis (IPF), a progressive lung disease. Participants inhaled the drug or a placebo four times daily for 52 weeks. The main goal was to measure changes in forced vital capacity (FVC), a key breathing test. The study is complete, and results will show if treprostinil helps preserve lung function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inhaled treprostinil (Tyvaso)
What this could lead to
If it works, this could offer a new inhaled treatment to slow lung function decline in people with idiopathic pulmonary fibrosis.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not significantly slow disease progression, and side effects from inhaled treprostinil can include cough, headache, and throat irritation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

598 people

The number who actually took part.

Started

Jun 2021

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis interstitial lung disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis Interstitial lung disease

Contacts and locations

Locations

  • A & A Research Consultants, LLC

    McAllen, Texas, 78503, United States

  • Adventist Healthcare White Oak Medical CEnter

    Silver Spring, Maryland, 20904, United States

  • Arizona Pulmonary Specialists, Ltd.

    Phoenix, Arizona, 85012, United States

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204, United States

  • Banner University Medical Center-Phoenix

    Phoenix, Arizona, 85006, United States

  • Baylor Clinic-Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Central Florida Pulmonary Group, PA

    Orlando, Florida, 32803, United States

  • Centre d'investigation Clinique Mauricie

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Centro Respiratorio Integral LTDA. (CENRESIN)

    Quillota, Valparaiso, 2260000, Chile

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732, United States

  • Coastal Pulmonary & Critical Care PLC

    St. Petersburg, Florida, 33704, United States

  • Community Health Network

    Indianapolis, Indiana, 46250, United States

  • Corewell Health William Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

  • Creighton University Clinical Research Office

    Omaha, Nebraska, 68124, United States

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095, United States

  • Dynamic Drug Advancement Limited

    Ajax, Ontario, L1S 2J5, Canada

  • East Carolina University and Leo Jenkins Cancer Center

    Greenville, North Carolina, 27834, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Fundacion Medica San Cristobal

    Santiago, Santiago Metropolitan, 7630226, Chile

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite

    Québec, G1V 4G5, Canada

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Johns Hopkins Asthma & Allergy Center

    Baltimore, Maryland, 21224, United States

  • LSU Health Science Center Shreveport

    Shreveport, Louisiana, 71103, United States

  • LSU Health Sciences Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Metroplex Pulmonary and Sleep Center PA

    McKinney, Texas, 75069, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • NewportNativeMD, Inc

    Newport Beach, California, 92663, United States

  • Northwell Health

    New Hyde Park, New York, 11040, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Norton Pulmonary Specialists

    Louisville, Kentucky, 40202, United States

  • Palmtree Clinical Research, Inc.

    Palm Springs, California, 92262, United States

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

    Hershey, Pennsylvania, 17033, United States

  • Piedmont Healthcare Atlanta

    Atlanta, Georgia, 30309, United States

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texas, 75020, United States

  • Prisma Health Midlands

    Columbia, South Carolina, 29203, United States

  • PulmonIx, LLC

    Greensboro, North Carolina, 27403, United States

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230, United States

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

    Kissimmee, Florida, 34741, United States

  • Renovatio Clinical Consultants, LLC

    The Woodlands, Texas, 77380, United States

  • Rush University Medical Center Outpatient Pulmonary Clinic

    Chicago, Illinois, 60612, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103, United States

  • St Joseph's Physician's Pulmonary Health

    Liverpool, New York, 13088, United States

  • St. Francis Sleep Allergy & Lung Institute

    Clearwater, Florida, 33765, United States

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6, Canada

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

    Phoenix, Arizona, 85013, United States

  • St.Paul's Hospital

    Vancouver, British Columbia, V6Z1Y6, Canada

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Statecare Pulmonary Consultants

    Knoxville, Tennessee, 37919, United States

  • Stony Brook Advanced Specialty Care

    Stony Brook, New York, 11725, United States

  • Temple Lung Center

    Philadelphia, Pennsylvania, 19140, United States

  • The Lung Research Center

    Chesterfield, Missouri, 63017, United States

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

    Columbus, Ohio, 43221, United States

  • The Oregon Clinic, PC

    Portland, Oregon, 97220, United States

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Thoams Jefferson,Hospital University

    Philadelphia, Pennsylvania, 19107, United States

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112, United States

  • UC Davis Health Medical Center

    Sacramento, California, 95817, United States

  • UC San Diego Health

    La Jolla, California, 92037, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of California - San Francisco

    San Francisco, California, 94143, United States

  • University of California, Irvine

    Orange, California, 92868, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Florida

    Jacksonville, Florida, 32209, United States

  • University of Florida Health at Shands

    Gainesville, Florida, 32610, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Michigan Int Med Pulmonary and critical care

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87106, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medical center

    Rochester, New York, 14642, United States

  • University of South Florida Health

    Tampa, Florida, 33606, United States

  • University of Utah Health

    Salt Lake City, Utah, 84108, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin School of Medicine and Public health

    Madison, Wisconsin, 53792, United States

  • Univrsity of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8550, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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