RecruitingPhase 3

Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)

United Therapeutics · NCT05943535

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation: Not posted. Ask the study team before screening.
Who can join: Ages 18+ · All sexes
Healthy volunteers: Not accepted (a condition is required)
Study type: Interventional · Phase 3
Target enrollment: 698
US sites recruiting: 74
Study start: October 30, 2023
Record last updated: July 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.

Being studied: Placebo; Inhaled Treprostinil; Treprostinil Ultrasonic Nebulizer

Conditions: Progressive Pulmonary Fibrosis; Interstitial Lung Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

Subject gives voluntary informed consent to participate in the study.
Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
Subject has radiological evidence of pulmonary fibrosis of >10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
Subject has a diagnosis of PPF (other than IPF) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator:

Clinically significant decline in % predicted FVC based on ≥10% relative decline
Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms
Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with increasing extent of fibrotic changes on chest imaging
Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
FVC ≥45% predicted at Screening (confirmed by central review).
Subjects must be on 1 of the following:

On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study
Not on treatment with nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, not planning to initiate either treatment during the study.

Concomitant use of both nintedanib and pirfenidone is not permitted.

Subjects treated with immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids, rituximab) need to be on treatment for at least 120 days prior to Baseline and, in the Investigator's clinical opinion, must be refractory to treatment.
Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will agree to do 1 of the following:

Abstain from intercourse (when it is in line with their preferred and usual lifestyle)
Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.

i. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide.

Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential.

Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
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

Subject is pregnant or lactating.
Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC \<0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).
Subject has a diagnosis of IPF.
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.
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), soluble guanylate cyclase stimulators, or activin signaling inhibitors (sotatercept) 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 prior to any study-related efficacy assessments.
Subject is receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
Exacerbation of ILD 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 ILD or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible.
Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
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.
Acute pulmonary embolism within 90 days prior to Baseline.
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.
In the opinion of the Investigator, life expectancy \<12 months due to ILD or a concomitant illness.
Subject has received nerandomilast within 60 days prior to Baseline.

Recruiting US locations

UAB Lung Health Center
Birmingham, AL 35233
Site contact: Melessia Wells · 205-975-9332 · mrasheed@uabmc.edu
Banner University Medical Center Phoenix Lung Institute
Phoenix, AZ 85006
Site contact: Surya Olguin · 602-521-3300 · suryaolguin@arizona.edu
Norton Thoracic Institute
Phoenix, AZ 85013
Site contact: Gabrielle Ambrose · 602-406-3825 · gabrielle.ambrose@commonspirit.org
Peter Morton Medical Building
Los Angeles, CA 90095
Site contact: Jennifer Perez · 310-825-5800 · jsperez@mednet.ucla.edu
NewportNativeMD, Inc.
Newport Beach, CA 92663
Site contact: Grace Harvey · 949-791-8599 · grace@newportnativemd.com
University of California Irvine Medical Center
Orange, CA 92868
Site contact: Jordan Perkins · 714-456-6875 · jperkin3@hs.uci.edu
Paradigm Clinical Research
Redding, CA 45227
Site contact: Mandy Swanson · 530-247-7049 · mswanson@paradigm-research.com
UC Davis Health Medical Center
Sacramento, CA 95817
Site contact: Sarah Natera · 916-734-1820 · srnatera@ucdavis.edu
Paradigm Clinical Research
San Diego, CA 92108
Site contact: Chery Bolovits · 858-274-4226 · cbolovits@paradigm-research.com
Stanford University Medical Center
Stanford, CA 94305
Site contact: Jannet Estrada · janestr@stanford.edu
Georgetown University Hospital
Washington D.C., DC 20007
Site contact: Amen Hamed · 202-444-0895 · amen.m.hamed@gunet.georgetown.edu
Ascension Medical Group St. Vincent's Lung Institute
Jacksonville, FL 32204
Site contact: Jennifer McWilliams · 904-308-5764 · jennifer.mcwilliams@ascension.org
Mayo Clinic
Jacksonville, FL 32224
Site contact: Inna Dawson · 904-953-3855 · dawson.inna@mayo.edu
TGH/USF Center for Advanced Lung Disease and Lung Transplant
Tampa, FL 33606
Site contact: Brenda Farlow · 813-844-3430 · bfarlow@tgh.org
Cleveland Clinic Florida
Weston, FL 33331
Site contact: Osvaldo Perez · 954-659-5570 · perezo4@ccf.org
The Emory Clinic
Atlanta, GA 45227
Site contact: Mitzi Near · 404-712-9603 · mnear@emory.edu
Northwestern Memorial Hospital, Clinical Research Unit
Chicago, IL 60611
Site contact: Aaron Gundersheimer · 312-503-7475 · aaron.gundersheimer@northwestern.edu
Rush University Medical Center Outpatient Pulmonary Clinic
Chicago, IL 60612
Site contact: Kimberly Saulsberry · 312-996-6275 · Kimberly_P_Saulsberry@rush.edu
UI Health Hospital
Chicago, IL 60612
Site contact: Hannah Carlson · hrc@uic.edu
Loyola University Medical Center
Maywood, IL 60153
Site contact: Adriana Martinez · 708-216-2057 · amartinez59@luc.edu
University of Kansas Medical Center
Kansas City, KS 66160
Site contact: Kimberly Lovell · 913-588-6067 · klovell@kumc.edu
University of Kentucky
Lexington, KY 45227
Site contact: Srushan Shankara bhaktula · 859-562-0882 · ssh486@uky.edu
University of Louisville Healthcare Outpatient Research Clinic
Louisville, KY 40202
Site contact: Belica Graf · 502-852-3184 · belica.graf@louisville.edu
Tulane Medical Center
New Orleans, LA 45227
Site contact: Sandy Ditta · 504-988-4040 · sditta@tulane.edu
Johns Hopkins Asthma and Allergy Center
Baltimore, MD 21224
Site contact: Sarah Collins · 410-550-2062 · shirsh1@jhmi.edu
University of Maryland Medical Center
Baltimore, MD 45227
Site contact: Maura Deeley · 410-328-4535 · madeeley@som.umaryland.edu
Adventist Healthcare White Oak Medical Center
Silver Spring, MD 20904
Site contact: Jennifer Hernandez · 240-637-5024 · jhernandez1@adventisthealthcare.com
Tufts Medical Center
Boston, MA 02111
Site contact: Mary Hays · 617-636-1334 · Mary.M.Hays@tuftsmedicine.org
Massachusetts General Hospital
Boston, MA 02114
Site contact: Layla Rahimi · 617-724-5548 · layla.rahimi@mgh.harvard.edu
Infinity Medical Center
North Dartmouth, MA 02747
Site contact: Cheryl O'Neil · 508-998-3041 · coneil@infinitymedicalresearch.com
Corewell Health Grand Rapids Hospitals - Butterworth
Grand Rapids, MI 49503
Site contact: Kendra Selby · 616-488-0281 · kendra.selby@helendevoschildrens.org
Beaumont Hospital, Royal Oak
Royal Oak, MI 48073
Site contact: Beverly Mauer · 248-551-2581 · beverly.maurer@corewellhealth.org
University of Minnesota Health Clinical Research Unit (CRU)
Minneapolis, MN 55455
Site contact: Amanda DeGrote · carl1032@umn.edu
Mayo Clinic
Rochester, MN 55905
Site contact: Teng Moua · 507-284-5398 · moua.teng@mayo.edu
Memorial Hospital at Gulfport
Gulfport, MS 39501
Site contact: Bobby W Tullos, MD
The Lung Research Center, LLC
Chesterfield, MO 63017
Site contact: Anna Shipp · 314-682-3653 · Anna.Shipp@stlukes-stl.com
Saint Luke's Hospital of Kansas City
Kansas City, MO 64111
Site contact: Rosann Gans · 816-304-1561 · rgans@saint-lukes.org
Washington University School of Medicine
St Louis, MO 63110
Site contact: Megan Baldenweck · 314-362-3705 · meganbaldenweck@wustl.edu
University of New Mexico
Albuquerque, NM 87131
Site contact: Frederick Gentry · 505-272-1160 · fgentry@salud.unm.edu
Northwell Health
New Hyde Park, NY 11042
Site contact: Sara Khan · 516-465-5437 · skhan109@northwell.edu
Weill Cornell Medicine, New York-Presbyterian Hospital
New York, NY 10065
Site contact: Christine Wu · 646-962-2833 · chw4019@med.cornell.edu
Stony Brook Advanced Specialty Care
Stony Brook, NY 11794-8172
Site contact: Jacqueline Skarre · 631-444-9033 · jacqueline.skarre@stonybrookmedicine.edu
Montefiore Medical Center
The Bronx, NY 10467
Site contact: Jane Wilson · 718-920-7916 · jwilson4@montefiore.org
Duke University Medical Center
Durham, NC 27710
Site contact: Lisa Holmes · 919-684-8726 · lisa1.holmes@duke.edu
PulmonIx LLC
Greensboro, NC 27403
Site contact: Lauren Hinshaw · 336-522-8870 · lauren.hinshaw@pulmonix.com
East Carolina University
Greenville, NC 27834
Site contact: Shravya Dharambhat · 252-744-1116 · dharambhats22@ecu.edu
Wake Forest Baptist Health
Winston-Salem, NC 27104
Site contact: Bob Hmieleski · 336-713-8555 · bhmieles@wakehealth.edu
University of Cincinnati Medical Center
Cincinnati, OH 45219
Site contact: Emillie Hoh · 513-584-1999 · hohek@ucmail.uc.edu
St. Luke's Univeristy Health Network-Pulmonary & Critical Care
Cincinnati, OH 45227
Site contact: Jena Hagerty · 484-526-3890 · Jena.hagerty@sluhn.org
The Ohio State University Wexner Medical CEnter
Columbus, OH 43201
Site contact: Benjamin Hood · 614-293-3351 · benjamin.hood2@osumc.edu
Mercy Health St.Vincent Medical Center LLC
Toledo, OH 43608
Site contact: Joseph Bandi · 419-251-4919 · jbandi@mercy.com
Pennsylvania State Hershey Medical Center and College of Medicine
Hershey, PA 17033
Site contact: Timothy Sheehan · 717-531-0003 · tsheehan@pennstatehealth.psu.edu
Hospital of the University of Pennsylvania
Philadelphia, PA 19104
Site contact: Sarah Alam · 609-668-7771 · sarah.alam@pennmedicine.upenn.edu
Jefferson Honickman Center
Philadelphia, PA 19107
Site contact: Ramya priya Talluri · 215-955-9792 · ramyapriya.talluri@jefferson.edu
Temple University Hospital
Philadelphia, PA 19140
Site contact: Kim Selwood · 215-707-1359 · kim.selwood@tuhs.temple.edu
Medical University of South Carolina-Nexus
Charleston, SC 29425
Site contact: Angela Francisco · 843-792-3710 · millare@musc.edu
Prisma Health Pulmonology-Richland
Columbia, SC 29203
Site contact: Keera McKenna · 803-434-8262 · keera.mckenna2@prismahealth.org
Clinical Trials Center of Middle Tennessee, LLC
Franklin, TN 37067
Site contact: Lindsey Robbs · 615-205-8350 · lrobbs@ctcmidtn.com
StatCare Pulmonary Consultants, PLLC
Knoxville, TN 37919
Site contact: Tabitha McCauley · 865-934-2672 · tabitha.mccauley@biomed-research.com
The Vanderbilt Lung Institute
Nashville, TN 37204
Site contact: Phyllis Young · 615-322-0368 · phyllis.d.young@vumc.org

+ 14 more on the official record.

Study contacts (from the official record)

United Therapeutics Global Medical Information · 919-485-8350 · clinicaltrials@unither.com