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

March 1, 2024 updated by: United Therapeutics

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study RIN-PF-301 is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute FVC in subjects with IPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will titrate to a target dosing regimen of 12 breaths QID. Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. Once eligible, 6 Treatment Period visits to the clinic will be required at Weeks 4, 8, 16, 28, 40, and 52.

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.

Study Type

Interventional

Enrollment (Estimated)

576

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Recruiting
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite
        • Principal Investigator:
          • Steeve Provencher, MD
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • Recruiting
        • St.Paul's Hospital
        • Contact:
        • Principal Investigator:
          • Christopher Ryerson, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H3A7
        • Recruiting
        • Queen Elizabeth II Health Sciences Centre
        • Principal Investigator:
          • Paul Hernandez, MD
        • Contact:
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Not yet recruiting
        • St. Joseph's Healthcare Hamilton
        • Principal Investigator:
          • Nathan Hambly, MD
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • The University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Tejaswini Kulkarni, MD
      • Jasper, Alabama, United States, 35501
        • Withdrawn
        • Jasper Summit Research, LLC
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • St. Joseph's Hospital and Medical Center - Norton Thoracic Institute
        • Contact:
        • Principal Investigator:
          • Rajat Walia, MD
      • Phoenix, Arizona, United States, 85012
        • Terminated
        • Arizona Pulmonary Specialists, Ltd.
      • Phoenix, Arizona, United States, 85006
        • Not yet recruiting
        • Banner University Medical Center-Phoenix
        • Contact:
        • Principal Investigator:
          • Sally Suliman, MD
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
        • Contact:
        • Principal Investigator:
          • Sachin Chaudhary, MD
    • California
      • La Jolla, California, United States, 92037
        • Not yet recruiting
        • UC San Diego Health
        • Contact:
        • Principal Investigator:
          • Gordon Yung, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • David Geffen School of Medicine at UCLA
        • Contact:
        • Principal Investigator:
          • Samuel Weigt, MD
      • Newport Beach, California, United States, 92663
        • Recruiting
        • NewportNativeMD, Inc
        • Contact:
        • Principal Investigator:
          • Ryan Klein, MD
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine
        • Principal Investigator:
          • Bassam Yaghmour, MD
        • Contact:
      • Palm Springs, California, United States, 92262
        • Recruiting
        • Palmtree Clinical Research, Inc.
        • Contact:
        • Principal Investigator:
          • Ziad Tannous, MD
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • UC Davis Health Medical Center
        • Principal Investigator:
          • Namita Sood, MD
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California - San Francisco
        • Contact:
        • Principal Investigator:
          • Jeffrey Golden, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University Medical Center
        • Contact:
        • Principal Investigator:
          • Rishi Raj, MD
    • Colorado
      • Denver, Colorado, United States, 80206
        • Recruiting
        • National Jewish Health
        • Principal Investigator:
          • Joshua Solomon, MD
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Hospital
        • Principal Investigator:
          • Tunay Kuru, MD
        • Contact:
    • Florida
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • St. Francis Sleep Allergy & Lung Institute
        • Contact:
        • Principal Investigator:
          • Francis Averill, MD
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Health at Shands
        • Contact:
        • Principal Investigator:
          • Ibrahim Faruqi, MD
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Contact:
        • Principal Investigator:
          • Augustine Lee, MD
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Vandana Seeram, MD
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • Ascension St. Vincent's
        • Contact:
        • Principal Investigator:
          • Harish Bhaskar, MD
      • Kissimmee, Florida, United States, 34741
        • Terminated
        • Pulmonary Disease Specialists, PA d/b/a PDS Research
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Central Florida Pulmonary Group, PA
        • Principal Investigator:
          • Syed Mobin, MD
        • Contact:
      • Palm Beach, Florida, United States, 33470
        • Recruiting
        • Advanced Pulmonary Research Institute
        • Contact:
        • Principal Investigator:
          • Neal Warshoff, MD
      • Saint Petersburg, Florida, United States, 33704
        • Terminated
        • Coastal Pulmonary & Critical Care PLC
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida Health
        • Principal Investigator:
          • Debabrata Bandyopadhyay, MD
        • Contact:
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida
        • Principal Investigator:
          • Jinesh Mehta, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Principal Investigator:
          • Srihari Veeraraghavan, MD
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Healthcare Atlanta
        • Contact:
        • Principal Investigator:
          • Amy Case, MD
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • The Queen's Medical Center
        • Contact:
        • Principal Investigator:
          • Nishal Brahmbhatt, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Jane Dematte D'Amico, MD
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Principal Investigator:
          • Dustin Fraidenburg, MD
        • Contact:
          • Hannah Carlson
          • Phone Number: 312-355-5895
          • Email: hrc@uic.edu
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center Outpatient Pulmonary Clinic
        • Contact:
        • Principal Investigator:
          • Xiaoping Wu, MD
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Principal Investigator:
          • Daniel Dilling, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network
        • Contact:
        • Principal Investigator:
          • Sasikanth Adigopula, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Medical Center
        • Principal Investigator:
          • Sahil Pandya, MD
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Contact:
        • Principal Investigator:
          • Mohammed Saad, MD
      • Louisville, Kentucky, United States, 40202
      • Louisville, Kentucky, United States, 40207
        • Withdrawn
        • Louisville Pulmonary Care,PLLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph Lasky, MD
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • LSU Health Sciences Center New Orleans
        • Principal Investigator:
          • Amita Krishnan, MD
        • Contact:
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • LSU Health Science Center Shreveport
        • Principal Investigator:
          • Prangthip Charoenpong, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins Asthma & Allergy Center
        • Contact:
        • Principal Investigator:
          • Sonye Danoff, MD
      • Silver Spring, Maryland, United States, 20904
        • Recruiting
        • Adventist Healthcare White Oak Medical Center
        • Contact:
        • Principal Investigator:
          • Jonathan B Cohen, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Gary Hunninghake, MD
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Principal Investigator:
          • Nicholas Hill, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Int Med Pulmonary and critical care
        • Contact:
        • Principal Investigator:
          • Elizabeth Belloli, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Krishna Thavarajah, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Hyun Kim, MD
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Teng Moua, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Principal Investigator:
          • Andrew Wilhelm, MD
        • Contact:
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • The Lung Research Center
        • Contact:
        • Principal Investigator:
          • Neil Ettinger, MD
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital of Kansas City
        • Contact:
        • Principal Investigator:
          • Mark Yagan, MD
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Tonya Russell, MD
      • Saint Louis, Missouri, United States, 72032
        • Withdrawn
        • J&L Research, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • Creighton University Clinical Research Office
        • Contact:
        • Principal Investigator:
          • Lee Morrow, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Ali Mansour, MD
      • Liverpool, New York, United States, 13088
        • Recruiting
        • St Joseph's Physician's Pulmonary Health
        • Principal Investigator:
          • Sherif El Bayadi, MD
        • Contact:
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Northwell Health
        • Principal Investigator:
          • Arunabh Talwar, MD
        • Contact:
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
        • Principal Investigator:
          • Mathew R Kottmann, MD
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Recruiting
        • PulmonIx, LLC
        • Contact:
        • Principal Investigator:
          • Murali Ramaswamy, MD
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University and Leo Jenkins Cancer Center
        • Contact:
        • Principal Investigator:
          • Shehabaldin M Alqalyoobi, MD
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • Pinehurst Medical Clinic, Inc.
        • Principal Investigator:
          • Michael Pritchett, DO
        • Contact:
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Contact:
        • Principal Investigator:
          • Nishant Gupta, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Joseph Parambil, MD
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion
        • Contact:
        • Principal Investigator:
          • Nitin Bhatt, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Principal Investigator:
          • Jad Kebbe, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97220
        • Recruiting
        • The Oregon Clinic, PC
        • Contact:
        • Principal Investigator:
          • Granthem Farr, MD
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Milton S. Hershey Medical Center/Penn State College of Medicine
        • Contact:
        • Principal Investigator:
          • Rebecca Bascom, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Michaela Restivo Anderson, MD
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple Lung Center
        • Principal Investigator:
          • Parth Rali, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thoams Jefferson,Hospital University
        • Principal Investigator:
          • Gautam George, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Rachana Krishna, MD
      • Columbia, South Carolina, United States, 29203
        • Not yet recruiting
        • Prisma Health Midlands
        • Contact:
        • Principal Investigator:
          • Abhi Gupta, MD
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Clinical Research of Rock Hill
        • Contact:
        • Principal Investigator:
          • Michael Denenberg, MD
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Clinical Trials Center of Middle Tennessee
        • Principal Investigator:
          • Aaron Milstone, MD
        • Contact:
      • Knoxville, Tennessee, United States, 37919
      • Nashville, Tennessee, United States, 37204
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Justin Hewlett, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center
        • Contact:
        • Principal Investigator:
          • Yosafe Wakwaya, MD
      • Dallas, Texas, United States, 75390-8550
        • Not yet recruiting
        • Univrsity of Texas Southwestern Medical Center
        • Principal Investigator:
          • Traci Adams, MD
        • Contact:
      • Denison, Texas, United States, 75020
        • Recruiting
        • Premier Pulmonary Critical Care and Sleep Medicine
        • Principal Investigator:
          • Sanober Kable, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
        • Principal Investigator:
          • Rahat Hussain, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor Clinic-Baylor College of Medicine
        • Principal Investigator:
          • Ivan Rosas, MD
        • Contact:
      • McAllen, Texas, United States, 78503
        • Not yet recruiting
        • A & A Research Consultants, LLC
        • Contact:
        • Principal Investigator:
          • Alfredo Arauco Brown, MD
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Metroplex Pulmonary and Sleep Center PA
        • Principal Investigator:
          • Shahrukh Kureishy, MD
        • Contact:
      • The Woodlands, Texas, United States, 77380
        • Active, not recruiting
        • Renovatio Clinical Consultants, LLC
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Contact:
        • Principal Investigator:
          • Peter Crossno, MD
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah Health
        • Principal Investigator:
          • Mary Beth Scholand, MD
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Health System
        • Contact:
        • Principal Investigator:
          • Hannah Mannem, MD
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Hospital
        • Contact:
        • Principal Investigator:
          • Christopher King, MD
      • Richmond, Virginia, United States, 23230
        • Recruiting
        • Pulmonary Associates of Richmond, Inc.
        • Contact:
        • Principal Investigator:
          • Shilpa Johri, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin School of Medicine and Public Health
        • Contact:
        • Principal Investigator:
          • Stephen J Halliday, MD
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Mark Barash, DO
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo inhaled using an ultrasonic nebulizer QID
Drug: Placebo
Placebo administered QID
Device: Treprostinil Ultrasonic Nebulizer
Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Experimental: 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.
Device: Treprostinil Ultrasonic Nebulizer
Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Drug: Inhaled Treprostinil
Inhaled treprostinil (6 mcg/breath) administered QID
Other Names:
  • Tyvaso

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Absolute FVC from Baseline to Week 52
Time Frame: Baseline to Week 52
The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.
Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Clinical Worsening
Time Frame: Baseline to Week 52
Clinical worsening was monitored from randomization until 1 of the following criteria were met: death (all causes), hospitalization due to a respiratory indication, or 10% relative decline in % predicted FVC.
Baseline to Week 52
Time to First Acute Exacerbation of IPF
Time Frame: Baseline to Week 52
An exacerbation of IPF is defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality.
Baseline to Week 52
Change in % Predicted FVC from Baseline to Week 52
Time Frame: Baseline to Week 52
The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath. Percent predicted FVC is calculated based on factors such as ethnicity, sex, age, height, and weight.
Baseline to Week 52
Change in K-BILD Questionnaire Score from Baseline to Week 52
Time Frame: Baseline to Week 52
The K-BILD is a self-administered, 15-item questionnaire validated for patients with interstitial lung disease (ILD) consisting of 3 domains (breathlessness and activities, psychological, and chest symptoms).
Baseline to Week 52
Overall Survival at Week 52
Time Frame: Week 52
Vital status will be assessed for all subjects at Week 52, including those who discontinue the study prematurely or who withdraw consent.
Week 52
Change in DLCO from Baseline to Week 52
Time Frame: Baseline to Week 52
The DLCO measurement measures how well oxygen moves from the lungs to the blood.
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIN-PF-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Pulmonary Fibrosis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe