Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- United Therapeutics
- Study ID
- NCT05943535
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Interstitial Lung Disease
- Progressive Pulmonary Fibrosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Placebo — DRUGPlacebo administered QID
- Inhaled Treprostinil — DRUGInhaled treprostinil (6 mcg/breath) administered QID
- Treprostinil Ultrasonic Nebulizer — DEVICETreprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Study Details
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.
Key Dates
- Start date
- Oct 30, 2023
- Status verified
- Jun 2026
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 698 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: PlaceboMatching placebo inhaled using an ultrasonic nebulizer QID
- Experimental: Inhaled TreprostinilTreprostinil 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.
Primary Outcome Measure
Change in Absolute FVC from Baseline to Week 52 [ Time Frame: Baseline to Week 52 ]
Central Contacts
- United Therapeutics Global Medical Information919-485-8350
Locations (70)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UAB Lung Health Center | Birmingham | Alabama | 35233 | Tejaswini Kulkarni, MD (PRINCIPAL_INVESTIGATOR) |
| Banner University Medical Center Phoenix Lung Institute | Phoenix | Arizona | 85006 | Sally Suliman, MD (PRINCIPAL_INVESTIGATOR) |
| Norton Thoracic Institute | Phoenix | Arizona | 85013 | Rajat Walia, MD (PRINCIPAL_INVESTIGATOR) |
| Peter Morton Medical Building | Los Angeles | California | 90095 | Stephen S Weigt, MD (PRINCIPAL_INVESTIGATOR) |
| NewportNativeMD, Inc. | Newport Beach | California | 92663 | Ryan Klein, MD (PRINCIPAL_INVESTIGATOR) |
| University of California Irvine Medical Center | Orange | California | 92868 | Bassam Yaghmour, MD (PRINCIPAL_INVESTIGATOR) |
| Paradigm Clinical Research | Redding | California | 45227 | Rafael Lupercio, MD (PRINCIPAL_INVESTIGATOR) |
| UC Davis Health Medical Center | Sacramento | California | 95817 | Namita Sood, MD (PRINCIPAL_INVESTIGATOR) |
| Paradigm Clinical Research | San Diego | California | 92108 | Daniel Jones, MD (PRINCIPAL_INVESTIGATOR) |
| Stanford University Medical Center | Stanford | California | 94305 | Jannet Estrada Rishi Raj, MD (PRINCIPAL_INVESTIGATOR) |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | Cristina Reichner, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension Medical Group St. Vincent's Lung Institute | Jacksonville | Florida | 32204 | Akram Shibani, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Jacksonville | Florida | 32224 | Augustine S Lee, MD (PRINCIPAL_INVESTIGATOR) |
| TGH/USF Center for Advanced Lung Disease and Lung Transplant | Tampa | Florida | 33606 | Debabrata Bandyopadhyay, MD (PRINCIPAL_INVESTIGATOR) |
| The Emory Clinic | Atlanta | Georgia | 45227 | Srihari Veeraraghavan, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern Memorial Hospital, Clinical Research Unit | Chicago | Illinois | 60611 | Bradford Bemiss, MD (PRINCIPAL_INVESTIGATOR) |
| Rush University Medical Center Outpatient Pulmonary Clinic | Chicago | Illinois | 60612 | Mark Yoder, MD (PRINCIPAL_INVESTIGATOR) |
| UI Health Hospital | Chicago | Illinois | 60612 | Hannah Carlson Dustin Fraidenburg, MD (PRINCIPAL_INVESTIGATOR) |
| Loyola University Medical Center | Maywood | Illinois | 60153 | Daniel Dilling, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Sahil Pandya, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kentucky | Lexington | Kentucky | 45227 | Parijat Sen, MD (PRINCIPAL_INVESTIGATOR) |
| University of Louisville Healthcare Outpatient Research Clinic | Louisville | Kentucky | 40202 | Mohamed A Saad, MD (PRINCIPAL_INVESTIGATOR) |
| Tulane Medical Center | New Orleans | Louisiana | 45227 | Joseph Lasky, MD (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins Asthma and Allergy Center | Baltimore | Maryland | 21224 | Mathew Lammi, MD (PRINCIPAL_INVESTIGATOR) |
| University of Maryland Medical Center | Baltimore | Maryland | 45227 | Sarah R Williams (PRINCIPAL_INVESTIGATOR) |
| Adventist Healthcare White Oak Medical Center | Silver Spring | Maryland | 20904 | Jonathan Cohen, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Leo C Ginns, MD (PRINCIPAL_INVESTIGATOR) |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Nicholas Hill, MD (PRINCIPAL_INVESTIGATOR) |
| Infinity Medical Center | North Dartmouth | Massachusetts | 02747 | Curtis J Mello, MD (PRINCIPAL_INVESTIGATOR) |
| Corewell Health Grand Rapids Hospitals - Butterworth | Grand Rapids | Michigan | 49503 | Pranav Kidambi, MD (PRINCIPAL_INVESTIGATOR) |
| Beaumont Hospital, Royal Oak | Royal Oak | Michigan | 48073 | Enrique Calvo-Ayala, MD (PRINCIPAL_INVESTIGATOR) |
| University of Minnesota Health Clinical Research Unit (CRU) | Minneapolis | Minnesota | 55455 | Amanda DeGrote Hyun Kim, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55905 | Teng Moua, MD (PRINCIPAL_INVESTIGATOR) |
| Memorial Hospital at Gulfport | Gulfport | Mississippi | 39501 | Bobby W Tullos, MD (PRINCIPAL_INVESTIGATOR) |
| The Lung Research Center, LLC | Chesterfield | Missouri | 63017 | Neil Ettinger, MD (PRINCIPAL_INVESTIGATOR) |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | Mark Yagan, MD (PRINCIPAL_INVESTIGATOR) |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Tonya D. Russell, MD (PRINCIPAL_INVESTIGATOR) |
| University of New Mexico | Albuquerque | New Mexico | 87131 | Nour Assad, MD (PRINCIPAL_INVESTIGATOR) |
| Northwell Health | New Hyde Park | New York | 11042 | Arunabh Talwar, MD (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medicine, New York-Presbyterian Hospital | New York | New York | 10065 | Anna Podolanczuk, MD (PRINCIPAL_INVESTIGATOR) |
| Stony Brook Advanced Specialty Care | Stony Brook | New York | 11794-8172 | Alpa Desai, MD (PRINCIPAL_INVESTIGATOR) |
| Montefiore Medical Center | The Bronx | New York | 10467 | Ali Mansour, MD (PRINCIPAL_INVESTIGATOR) |
| Duke University Medical Center | Durham | North Carolina | 27710 | Lake Morrison, MD (PRINCIPAL_INVESTIGATOR) |
| PulmonIx LLC | Greensboro | North Carolina | 27403 | Murali Ramaswamy, MD (PRINCIPAL_INVESTIGATOR) |
| East Carolina University | Greenville | North Carolina | 27834 | Veeranna Maddipati, MD (PRINCIPAL_INVESTIGATOR) |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27104 | Heather Clark (PRINCIPAL_INVESTIGATOR) |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | Nishant Gupta, MD (PRINCIPAL_INVESTIGATOR) |
| The Ohio State University Wexner Medical CEnter | Columbus | Ohio | 43201 | Nitin Bhatt, MD (PRINCIPAL_INVESTIGATOR) |
| Mercy Health St.Vincent Medical Center LLC | Toledo | Ohio | 43608 | Vinod Khatri, MD (PRINCIPAL_INVESTIGATOR) |
| Pennsylvania State Hershey Medical Center and College of Medicine | Hershey | Pennsylvania | 17033 | Rebecca Bascom, MD (PRINCIPAL_INVESTIGATOR) |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Michaela Anderson, MD (PRINCIPAL_INVESTIGATOR) |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | Rali Parth, MD (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina-Nexus | Charleston | South Carolina | 29425 | Rachana Krishna, MD (PRINCIPAL_INVESTIGATOR) |
| Prisma Health Pulmonology-Richland | Columbia | South Carolina | 29203 | Abhinav Gupta, MD (PRINCIPAL_INVESTIGATOR) |
| Clinical Trials Center of Middle Tennessee, LLC | Franklin | Tennessee | 37067 | Aaron Milstone, MD (PRINCIPAL_INVESTIGATOR) |
| StatCare Pulmonary Consultants, PLLC | Knoxville | Tennessee | 37919 | Eric Weaver, MD (PRINCIPAL_INVESTIGATOR) |
| The Vanderbilt Lung Institute | Nashville | Tennessee | 37204 | Justin Hewlett, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor University Medical Center | Dallas | Texas | 75246 | Yosafe Wakwaya, MD (PRINCIPAL_INVESTIGATOR) |
| UT Southwestern Medical Center-Advanced Lung Clinic | Dallas | Texas | 75390 | Margaret Kypreos, MD (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist Outpatient Center | Houston | Texas | 77030 | Sandeep Sahay, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Texas Health Science Center at Houston, McGovern Medical School | Houston | Texas | 77030 | Rodeo Abrencillo, MD (PRINCIPAL_INVESTIGATOR) |
| A & A Research Consultants, LLC | McAllen | Texas | 78503 | Alfredo Renzo Arauco Brown, MD (PRINCIPAL_INVESTIGATOR) |
| Metroplex Pulmonary and Sleep Center | McKinney | Texas | 75069 | Shahrukh Kureishy, MD (PRINCIPAL_INVESTIGATOR) |
| Intermountain Medical Center | Murray | Utah | 84107 | Peter Crossno, MD (PRINCIPAL_INVESTIGATOR) |
| University of Utah Health | Salt Lake City | Utah | 84108 | Mary Scholand, MD (PRINCIPAL_INVESTIGATOR) |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | Hannah C Mannem, MD (PRINCIPAL_INVESTIGATOR) |
| Christopher King, MD | Falls Church | Virginia | 22042 | Christopher King, MD (PRINCIPAL_INVESTIGATOR) |
| Pulmonary Associates of Richmond, Inc. | Richmond | Virginia | 23230 | Shilpa Johri, MD (PRINCIPAL_INVESTIGATOR) |
| University Hospital and UW Health Clinics | Madison | Wisconsin | 53792 | Stephen J Halliday, MD (PRINCIPAL_INVESTIGATOR) |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-1222 | Mark Barash, MD (PRINCIPAL_INVESTIGATOR) |
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