Idiopathic Pulmonary Fibrosis Clinical Trial
— TETONOfficial title:
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
NCT number | NCT04708782 |
Other study ID # | RIN-PF-301 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | June 2025 |
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.
Status | Recruiting |
Enrollment | 576 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Dynamic Drug Advancement Limited | Ajax | Ontario |
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | St. Joseph's Healthcare Hamilton | Hamilton | Ontario |
Canada | Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite | Quebec | |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | Centre d'investigation Clinique Mauricie | Trois-Rivières | Quebec |
Canada | St.Paul's Hospital | Vancouver | British Columbia |
United States | University of New Mexico Health Sciences Center | Albuquerque | New Mexico |
United States | University of Michigan Int Med Pulmonary and critical care | Ann Arbor | Michigan |
United States | Emory University Hospital | Atlanta | Georgia |
United States | Piedmont Healthcare Atlanta | Atlanta | Georgia |
United States | Johns Hopkins Asthma & Allergy Center | Baltimore | Maryland |
United States | The University of Alabama at Birmingham | Birmingham | Alabama |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Virginia Health System | Charlottesville | Virginia |
United States | The Lung Research Center | Chesterfield | Missouri |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | Rush University Medical Center Outpatient Pulmonary Clinic | Chicago | Illinois |
United States | University of Illinois at Chicago | Chicago | Illinois |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | St. Francis Sleep Allergy & Lung Institute | Clearwater | Florida |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Prisma Health Midlands | Columbia | South Carolina |
United States | The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion | Columbus | Ohio |
United States | Baylor University Medical Center | Dallas | Texas |
United States | Univrsity of Texas Southwestern Medical Center | Dallas | Texas |
United States | Premier Pulmonary Critical Care and Sleep Medicine | Denison | Texas |
United States | National Jewish Health | Denver | Colorado |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | Clinical Trials Center of Middle Tennessee | Franklin | Tennessee |
United States | University of Florida Health at Shands | Gainesville | Florida |
United States | PulmonIx, LLC | Greensboro | North Carolina |
United States | East Carolina University and Leo Jenkins Cancer Center | Greenville | North Carolina |
United States | Penn State Milton S. Hershey Medical Center/Penn State College of Medicine | Hershey | Pennsylvania |
United States | The Queen's Medical Center | Honolulu | Hawaii |
United States | Baylor Clinic-Baylor College of Medicine | Houston | Texas |
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
United States | Community Health Network | Indianapolis | Indiana |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Ascension St. Vincent's | Jacksonville | Florida |
United States | Mayo Clinic Florida | Jacksonville | Florida |
United States | University of Florida | Jacksonville | Florida |
United States | Jasper Summit Research, LLC | Jasper | Alabama |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | The University of Kansas Medical Center | Kansas City | Kansas |
United States | Pulmonary Disease Specialists, PA d/b/a PDS Research | Kissimmee | Florida |
United States | Statecare Pulmonary Consultants | Knoxville | Tennessee |
United States | UC San Diego Health | La Jolla | California |
United States | St Joseph's Physician's Pulmonary Health | Liverpool | New York |
United States | David Geffen School of Medicine at UCLA | Los Angeles | California |
United States | Louisville Pulmonary Care,PLLC | Louisville | Kentucky |
United States | Norton Pulmonary Specialists | Louisville | Kentucky |
United States | University of Louisville | Louisville | Kentucky |
United States | University of Wisconsin School of Medicine and Public health | Madison | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | A & A Research Consultants, LLC | McAllen | Texas |
United States | Metroplex Pulmonary and Sleep Center PA | McKinney | Texas |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Intermountain Medical Center | Murray | Utah |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Northwell Health | New Hyde Park | New York |
United States | LSU Health Sciences Center New Orleans | New Orleans | Louisiana |
United States | Tulane University Medical Center | New Orleans | Louisiana |
United States | NewportNativeMD, Inc | Newport Beach | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Creighton University Clinical Research Office | Omaha | Nebraska |
United States | University of California, Irvine | Orange | California |
United States | Central Florida Pulmonary Group, PA | Orlando | Florida |
United States | Advanced Pulmonary Research Institute | Palm Beach | Florida |
United States | Palmtree Clinical Research, Inc. | Palm Springs | California |
United States | Temple Lung Center | Philadelphia | Pennsylvania |
United States | Thoams Jefferson,Hospital University | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Arizona Pulmonary Specialists, Ltd. | Phoenix | Arizona |
United States | Banner University Medical Center-Phoenix | Phoenix | Arizona |
United States | St. Joseph's Hospital and Medical Center - Norton Thoracic Institute | Phoenix | Arizona |
United States | Pinehurst Medical Clinic, Inc. | Pinehurst | North Carolina |
United States | The Oregon Clinic, PC | Portland | Oregon |
United States | Pulmonary Associates of Richmond, Inc. | Richmond | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Rochester Medical center | Rochester | New York |
United States | Clinical Research of Rock Hill | Rock Hill | South Carolina |
United States | UC Davis Health Medical Center | Sacramento | California |
United States | J&L Research, LLC | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Coastal Pulmonary & Critical Care PLC | Saint Petersburg | Florida |
United States | University of Utah Health | Salt Lake City | Utah |
United States | University of California - San Francisco | San Francisco | California |
United States | LSU Health Science Center Shreveport | Shreveport | Louisiana |
United States | Adventist Healthcare White Oak Medical CEnter | Silver Spring | Maryland |
United States | Stanford University Medical Center | Stanford | California |
United States | University of South Florida Health | Tampa | Florida |
United States | Renovatio Clinical Consultants, LLC | The Woodlands | Texas |
United States | University of Arizona | Tucson | Arizona |
United States | Georgetown University Hospital | Washington | District of Columbia |
United States | Cleveland Clinic Florida | Weston | Florida |
United States | Southeastern Research Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
United Therapeutics |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Absolute FVC from 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 | Time to Clinical Worsening | 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 | |
Secondary | Time to First Acute Exacerbation of IPF | 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 | |
Secondary | Overall Survival at 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 | |
Secondary | Change in % Predicted FVC from 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 | |
Secondary | Change in K-BILD Questionnaire Score from 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 | |
Secondary | Change in DLCO from Baseline to Week 52 | The DLCO measurement measures how well oxygen moves from the lungs to the blood. | Baseline to Week 52 |
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