English
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SpanishStudy 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 ≥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.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 | Active, not recruiting |
| Countries | Canada, Chile, 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
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The University of Alabama at Birmingham
Birmingham, Alabama, 35233
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Banner University Medical Center-Phoenix
Phoenix, Arizona, 85006
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Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, 85012
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St. Joseph's Hospital and Medical Center - Norton Thoracic Institute
Phoenix, Arizona, 85013
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University of Arizona
Tucson, Arizona, 85724
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UC San Diego Health
La Jolla, California, 92037
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David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
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NewportNativeMD, Inc
Newport Beach, California, 92663
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University of California, Irvine
Orange, California, 92868
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Palmtree Clinical Research, Inc.
Palm Springs, California, 92262
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UC Davis Health Medical Center
Sacramento, California, 95817
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University of California - San Francisco
San Francisco, California, 94143
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Stanford University Medical Center
Stanford, California, 94305
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National Jewish Health
Denver, Colorado, 80206
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St. Francis Sleep Allergy & Lung Institute
Clearwater, Florida, 33765
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University of Florida Health at Shands
Gainesville, Florida, 32610
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Ascension St. Vincent's
Jacksonville, Florida, 32204
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University of Florida
Jacksonville, Florida, 32209
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Mayo Clinic Florida
Jacksonville, Florida, 32224
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Pulmonary Disease Specialists, PA d/b/a PDS Research
Kissimmee, Florida, 34741
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Lakeland Regional Health
Lakeland, Florida, 33805
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Central Florida Pulmonary Group, PA
Orlando, Florida, 32803
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Coastal Pulmonary & Critical Care PLC
Saint Petersburg, Florida, 33704
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University of South Florida Health
Tampa, Florida, 33606
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Cleveland Clinic Florida
Weston, Florida, 33331
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Piedmont Healthcare Atlanta
Atlanta, Georgia, 30309
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Emory University Hospital
Atlanta, Georgia, 30322
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The Queen's Medical Center
Honolulu, Hawaii, 96813
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Northwestern Memorial Hospital
Chicago, Illinois, 60611
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Rush University Medical Center Outpatient Pulmonary Clinic
Chicago, Illinois, 60612
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University of Illinois at Chicago
Chicago, Illinois, 60612
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Loyola University Medical Center
Maywood, Illinois, 60153
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Community Health Network
Indianapolis, Indiana, 46250
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The University of Kansas Medical Center
Kansas City, Kansas, 66160
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Norton Pulmonary Specialists
Louisville, Kentucky, 40202
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University of Louisville
Louisville, Kentucky, 40202
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LSU Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
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Tulane University Medical Center
New Orleans, Louisiana, 70112
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LSU Health Science Center Shreveport
Shreveport, Louisiana, 71103
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Johns Hopkins Asthma & Allergy Center
Baltimore, Maryland, 21224
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Adventist Healthcare White Oak Medical CEnter
Silver Spring, Maryland, 20904
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Tufts Medical Center
Boston, Massachusetts, 02111
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Massachusetts General Hospital
Boston, Massachusetts, 02114
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Brigham and Women's Hospital
Boston, Massachusetts, 02115
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University of Michigan Int Med Pulmonary and critical care
Ann Arbor, Michigan, 48109
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Henry Ford Hospital
Detroit, Michigan, 48202
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Corewell Health William Beaumont Hospital
Royal Oak, Michigan, 48073
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University of Minnesota
Minneapolis, Minnesota, 55455
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Mayo Clinic
Rochester, Minnesota, 55902
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University of Mississippi Medical Center
Jackson, Mississippi, 39216
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The Lung Research Center
Chesterfield, Missouri, 63017
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Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
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Washington University School of Medicine
Saint Louis, Missouri, 63110
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Creighton University Clinical Research Office
Omaha, Nebraska, 68124
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University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106
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Montefiore Medical Center
Bronx, New York, 10467
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St Joseph's Physician's Pulmonary Health
Liverpool, New York, 13088
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Northwell Health
New Hyde Park, New York, 11040
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University of Rochester Medical center
Rochester, New York, 14642
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Stony Brook Advanced Specialty Care
Stony Brook, New York, 11725
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PulmonIx, LLC
Greensboro, North Carolina, 27403
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East Carolina University and Leo Jenkins Cancer Center
Greenville, North Carolina, 27834
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Southeastern Research Center
Winston-Salem, North Carolina, 27103
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University of Cincinnati
Cincinnati, Ohio, 45267
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Cleveland Clinic
Cleveland, Ohio, 44195
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The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion
Columbus, Ohio, 43221
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
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The Oregon Clinic, PC
Portland, Oregon, 97220
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Penn State Milton S. Hershey Medical Center/Penn State College of Medicine
Hershey, Pennsylvania, 17033
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104
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Thoams Jefferson,Hospital University
Philadelphia, Pennsylvania, 19107
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Temple Lung Center
Philadelphia, Pennsylvania, 19140
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Medical University of South Carolina
Charleston, South Carolina, 29425
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Prisma Health Midlands
Columbia, South Carolina, 29203
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Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
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Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 37067
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Statecare Pulmonary Consultants
Knoxville, Tennessee, 37919
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Vanderbilt University Medical Center
Nashville, Tennessee, 37204
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Baylor University Medical Center
Dallas, Texas, 75246
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Univrsity of Texas Southwestern Medical Center
Dallas, Texas, 75390-8550
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Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020
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Baylor Clinic-Baylor College of Medicine
Houston, Texas, 77030
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The University of Texas Health Science Center at Houston
Houston, Texas, 77030
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A & A Research Consultants, LLC
McAllen, Texas, 78503
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Metroplex Pulmonary and Sleep Center PA
McKinney, Texas, 75069
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Renovatio Clinical Consultants, LLC
The Woodlands, Texas, 77380
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Intermountain Medical Center
Murray, Utah, 84107
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University of Utah Health
Salt Lake City, Utah, 84108
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University of Virginia Health System
Charlottesville, Virginia, 22903
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Inova Fairfax Hospital
Falls Church, Virginia, 22042
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Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23230
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University of Wisconsin School of Medicine and Public health
Madison, Wisconsin, 53792
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
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St.Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
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Dynamic Drug Advancement Limited
Ajax, Ontario, L1S 2J5
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St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
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Toronto General Hospital
Toronto, Ontario, M5G 2C4
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Centre d'investigation Clinique Mauricie
Trois-Rivières, Quebec, G8T 7A1
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Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite
Quebec, , G1V 4G5
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Fundacion Medica San Cristobal
Santiago, Region Metropolitana, 7630226
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Centro Respiratorio Integral LTDA. (CENRESIN)
Quillota, Valparaiso, 2260000
