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Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 40 Years and Over |
| Gender | All |
Inclusion Criteria:
1. Subject gives voluntary informed consent to participate in the study. 2. Subject is ā„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 ā„45% predicted at Screening. 5. Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for ā„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.Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04708782 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
United Therapeutics |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Canada, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease |
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.
Arms
Placebo Comparator: Placebo
Matching placebo inhaled using an ultrasonic nebulizer QID
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.
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
Status
Withdrawn
Address
Jasper Summit Research, LLC
Jasper, Alabama, 35501
Status
Not yet recruiting
Address
Banner University Medical Center-Phoenix
Phoenix, Arizona, 85006
Status
Terminated
Address
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, 85012
Status
Recruiting
Address
St. Joseph's Hospital and Medical Center - Norton Thoracic Institute
Phoenix, Arizona, 85013
Status
Recruiting
Address
University of Arizona
Tucson, Arizona, 85724
Status
Not yet recruiting
Address
UC San Diego Health
La Jolla, California, 92037
Status
Recruiting
Address
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Status
Recruiting
Address
NewportNativeMD, Inc
Newport Beach, California, 92663
Status
Recruiting
Address
University of California, Irvine
Orange, California, 92868
Status
Recruiting
Address
Palmtree Clinical Research, Inc.
Palm Springs, California, 92262
Status
Not yet recruiting
Address
UC Davis Health Medical Center
Sacramento, California, 95817
Status
Recruiting
Address
University of California - San Francisco
San Francisco, California, 94143
Status
Recruiting
Address
Stanford University Medical Center
Stanford, California, 94305
Status
Recruiting
Address
National Jewish Health
Denver, Colorado, 80206
Status
Recruiting
Address
Georgetown University Hospital
Washington, District of Columbia, 20007
Status
Recruiting
Address
St. Francis Sleep Allergy & Lung Institute
Clearwater, Florida, 33765
Status
Recruiting
Address
University of Florida Health at Shands
Gainesville, Florida, 32610
Status
Recruiting
Address
Ascension St. Vincent's
Jacksonville, Florida, 32204
Status
Recruiting
Address
University of Florida
Jacksonville, Florida, 32209
Status
Recruiting
Address
Mayo Clinic Florida
Jacksonville, Florida, 32224
Status
Terminated
Address
Pulmonary Disease Specialists, PA d/b/a PDS Research
Kissimmee, Florida, 34741
Status
Recruiting
Address
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803
Status
Recruiting
Address
Advanced Pulmonary Research Institute
Palm Beach, Florida, 33470
Status
Terminated
Address
Coastal Pulmonary & Critical Care PLC
Saint Petersburg, Florida, 33704
Status
Recruiting
Address
University of South Florida Health
Tampa, Florida, 33606
Status
Recruiting
Address
Cleveland Clinic Florida
Weston, Florida, 33331
Status
Recruiting
Address
Piedmont Healthcare Atlanta
Atlanta, Georgia, 30309
Status
Recruiting
Address
Emory University Hospital
Atlanta, Georgia, 30322
Status
Recruiting
Address
The Queen's Medical Center
Honolulu, Hawaii, 96813
Status
Recruiting
Address
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Status
Recruiting
Address
Rush University Medical Center Outpatient Pulmonary Clinic
Chicago, Illinois, 60612
Status
Recruiting
Address
University of Illinois at Chicago
Chicago, Illinois, 60612
Status
Recruiting
Address
Loyola University Medical Center
Maywood, Illinois, 60153
Status
Recruiting
Address
Community Health Network
Indianapolis, Indiana, 46250
Status
Recruiting
Address
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
Norton Pulmonary Specialists
Louisville, Kentucky, 40202
Status
Recruiting
Address
University of Louisville
Louisville, Kentucky, 40202
Status
Withdrawn
Address
Louisville Pulmonary Care,PLLC
Louisville, Kentucky, 40207
Status
Recruiting
Address
LSU Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
Status
Recruiting
Address
Tulane University Medical Center
New Orleans, Louisiana, 70112
Status
Recruiting
Address
LSU Health Science Center Shreveport
Shreveport, Louisiana, 71103
Status
Recruiting
Address
Johns Hopkins Asthma & Allergy Center
Baltimore, Maryland, 21224
Status
Recruiting
Address
Adventist Healthcare White Oak Medical CEnter
Silver Spring, Maryland, 20904
Status
Recruiting
Address
Tufts Medical Center
Boston, Massachusetts, 02111
Status
Recruiting
Address
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Status
Recruiting
Address
University of Michigan Int Med Pulmonary and critical care
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Henry Ford Hospital
Detroit, Michigan, 48202
Status
Recruiting
Address
University of Minnesota
Minneapolis, Minnesota, 55455
Status
Recruiting
Address
Mayo Clinic
Rochester, Minnesota, 55902
Status
Recruiting
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Recruiting
Address
The Lung Research Center
Chesterfield, Missouri, 63017
Status
Recruiting
Address
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Withdrawn
Address
J&L Research, LLC
Saint Louis, Missouri, 72032
Status
Recruiting
Address
Creighton University Clinical Research Office
Omaha, Nebraska, 68124
Status
Recruiting
Address
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106
Status
Recruiting
Address
Montefiore Medical Center
Bronx, New York, 10467
Status
Recruiting
Address
St Joseph's Physician's Pulmonary Health
Liverpool, New York, 13088
Status
Recruiting
Address
Northwell Health
New Hyde Park, New York, 11040
Status
Recruiting
Address
University of Rochester Medical center
Rochester, New York, 14642
Status
Recruiting
Address
PulmonIx, LLC
Greensboro, North Carolina, 27403
Status
Recruiting
Address
East Carolina University and Leo Jenkins Cancer Center
Greenville, North Carolina, 27834
Status
Recruiting
Address
Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina, 28374
Status
Recruiting
Address
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Status
Recruiting
Address
University of Cincinnati
Cincinnati, Ohio, 45267
Status
Recruiting
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Recruiting
Address
The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion
Columbus, Ohio, 43221
Status
Recruiting
Address
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Status
Recruiting
Address
The Oregon Clinic, PC
Portland, Oregon, 97220
Status
Recruiting
Address
Penn State Milton S. Hershey Medical Center/Penn State College of Medicine
Hershey, Pennsylvania, 17033
Status
Recruiting
Address
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Thoams Jefferson,Hospital University
Philadelphia, Pennsylvania, 19107
Status
Recruiting
Address
Temple Lung Center
Philadelphia, Pennsylvania, 19140
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Not yet recruiting
Address
Prisma Health Midlands
Columbia, South Carolina, 29203
Status
Recruiting
Address
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Status
Recruiting
Address
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 37067
Status
Recruiting
Address
Statecare Pulmonary Consultants
Knoxville, Tennessee, 37919
Status
Recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
Status
Recruiting
Address
Baylor University Medical Center
Dallas, Texas, 75246
Status
Not yet recruiting
Address
Univrsity of Texas Southwestern Medical Center
Dallas, Texas, 75390-8550
Status
Recruiting
Address
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020
Status
Recruiting
Address
Baylor Clinic-Baylor College of Medicine
Houston, Texas, 77030
Status
Recruiting
Address
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Status
Not yet recruiting
Address
A & A Research Consultants, LLC
McAllen, Texas, 78503
Status
Recruiting
Address
Metroplex Pulmonary and Sleep Center PA
McKinney, Texas, 75069
Status
Active, not recruiting
Address
Renovatio Clinical Consultants, LLC
The Woodlands, Texas, 77380
Status
Recruiting
Address
Intermountain Medical Center
Murray, Utah, 84107
Status
Recruiting
Address
University of Utah Health
Salt Lake City, Utah, 84108
Status
Recruiting
Address
University of Virginia Health System
Charlottesville, Virginia, 22903
Status
Recruiting
Address
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Status
Recruiting
Address
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23230
Status
Recruiting
Address
University of Wisconsin School of Medicine and Public health
Madison, Wisconsin, 53792
Status
Not yet recruiting
Address
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
Status
Recruiting
Address
St.Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
Status
Recruiting
Address
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H3A7
Status
Not yet recruiting
Address
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Status
Recruiting
Address
Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite
Quebec, , G1V 4G5
