Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Start Date
10/30/2023
Completion Date
11/1/2027
Summary
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.
Detailed Description
Study RIN-PF-305 is a Phase 3, multinational, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of inhaled treprostinil in subjects with PPF 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 (forced vital capacity \[FVC\]), time to clinical worsening, time to first acute exacerbation of interstitial lung disease (ILD), 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Placebo
Inhaled Treprostinil
Treprostinil Ultrasonic Nebulizer
Conditions
Locations
UAB Lung Health Center
Birmingham, Alabama 35233
United States
Banner University Medical Center Phoenix Lung Institute
Phoenix, Arizona 85006
United States
Norton Thoracic Institute
Phoenix, Arizona 85013
United States
Peter Morton Medical Building
Los Angeles, California 90095
United States
NewportNativeMD, Inc.
Newport Beach, California 92663
United States
University of California Irvine Medical Center
Orange, California 92868
United States
Paradigm Clinical Research
Redding, California 45227
United States
UC Davis Health Medical Center
Sacramento, California 95817
United States
Paradigm Clinical Research
San Diego, California 92108
United States
Stanford University Medical Center
Stanford, California 94305
United States
Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
Ascension Medical Group St. Vincent's Lung Institute
Jacksonville, Florida 32204
United States
Mayo Clinic
Jacksonville, Florida 32224
United States
TGH/USF Center for Advanced Lung Disease and Lung Transplant
Tampa, Florida 33606
United States
Cleveland Clinic Florida
Weston, Florida 33331
United States
The Emory Clinic
Atlanta, Georgia 45227
United States
Northwestern Memorial Hospital, Clinical Research Unit
Chicago, Illinois 60611
United States
Rush University Medical Center Outpatient Pulmonary Clinic
Chicago, Illinois 60612
United States
UI Health Hospital
Chicago, Illinois 60612
United States
Loyola University Medical Center
Maywood, Illinois 60153
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
University of Kentucky
Lexington, Kentucky 45227
United States
University of Louisville Healthcare Outpatient Research Clinic
Louisville, Kentucky 40202
United States
Tulane Medical Center
New Orleans, Louisiana 45227
United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland 21224
United States
University of Maryland Medical Center
Baltimore, Maryland 45227
United States
Adventist Healthcare White Oak Medical Center
Silver Spring, Maryland 20904
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Infinity Medical Center
North Dartmouth, Massachusetts 02747
United States
Corewell Health Grand Rapids Hospitals - Butterworth
Grand Rapids, Michigan 49503
United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan 48073
United States
University of Minnesota Health Clinical Research Unit (CRU)
Minneapolis, Minnesota 55455
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Memorial Hospital at Gulfport
Gulfport, Mississippi 39501
United States
The Lung Research Center, LLC
Chesterfield, Missouri 63017
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
University of New Mexico
Albuquerque, New Mexico 87131
United States
Northwell Health
New Hyde Park, New York 11042
United States
Weill Cornell Medicine, New York-Presbyterian Hospital
New York, New York 10065
United States
Stony Brook Advanced Specialty Care
Stony Brook, New York 11794-8172
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
PulmonIx LLC
Greensboro, North Carolina 27403
United States
East Carolina University
Greenville, North Carolina 27834
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina 27104
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
St. Luke's Univeristy Health Network-Pulmonary & Critical Care
Cincinnati, Ohio 45227
United States
The Ohio State University Wexner Medical CEnter
Columbus, Ohio 43201
United States
Mercy Health St.Vincent Medical Center LLC
Toledo, Ohio 43608
United States
Pennsylvania State Hershey Medical Center and College of Medicine
Hershey, Pennsylvania 17033
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Jefferson Honickman Center
Philadelphia, Pennsylvania 19107
United States
Temple University Hospital
Philadelphia, Pennsylvania 19140
United States
Medical University of South Carolina-Nexus
Charleston, South Carolina 29425
United States
Prisma Health Pulmonology-Richland
Columbia, South Carolina 29203
United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee 37067
United States
StatCare Pulmonary Consultants, PLLC
Knoxville, Tennessee 37919
United States
The Vanderbilt Lung Institute
Nashville, Tennessee 37204
United States
Baylor University Medical Center
Dallas, Texas 75246
United States
UT Southwestern Medical Center-Advanced Lung Clinic
Dallas, Texas 75390
United States
Houston Methodist Outpatient Center
Houston, Texas 77030
United States
The University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas 77030
United States
A & A Research Consultants, LLC
McAllen, Texas 78503
United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069
United States
Methodist Hospital
San Antonio, Texas 78229
United States
Intermountain Medical Center
Murray, Utah 84107
United States
University of Utah Health
Salt Lake City, Utah 84108
United States
University of Virginia Health System
Charlottesville, Virginia 22903
United States
Christopher King, MD
Falls Church, Virginia 22042
United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia 23230
United States
University Hospital and UW Health Clinics
Madison, Wisconsin 53792
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226-1222
United States
Instituto Ave Pulmo - Fundacion enfisema
Mar del Plata, Buenos Aires 7600
Argentina
Instituto Medico Rio Cuarto
Río Cuarto, Córdoba Province 5800
Argentina
Sanatorio Parque de Rosario - Consultorios Externos
Rosario, Santa Fe Province 2000
Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province 4000
Argentina
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Tucumán Province
Argentina
CINME Centro de Investigaciones Metabolicas
Buenos Aires, C1056ABI
Argentina
Fundación Respirar
Buenos Aires, C1426ABP
Argentina
Instituto de Medicina Respiratoria
Córdoba, 5003
Argentina
Sanatorio Allende Cerro
Córdoba, 5021
Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
Australia
St George Hospital
Kogarah, New South Wales 2217
Australia
The Prince Charles Hospital
Brisbane, Queensland Australia
Australia
Lung Research QLD
Chermside, Queensland 4032
Australia
Eastern Health Box Hill Hospital
Box Hill, Victoria 3128
Australia
Monash Health-Monash Medical Centre
Clayton, Victoria 3168
Australia
Austin Health
Heidelberg, Victoria 3084
Australia
Institute for Respiratory Health - Midland
Midland, Western Australia 6056
Australia
Institute for Respiratory Health
Nedlands, Western Australia 6009
Australia
AZORG
Aalst, 9300
Belgium
ZAS Middelheim
Antwerp, 2020
Belgium
CUB Hopital Erasmde
Brussels, 1070
Belgium
Cliniques Universitaires St.-Luc
Brussels, 1200
Belgium
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
UZ Leuven
Leuven, 3000
Belgium
CHU de Liège
Liège, 4000
Belgium
St.Paul's Hospital
Vancouver, British Columbia V6Z 176
Canada
Dynamic Drug Advancement Limited
Ajax, Ontario L1S 2J5
Canada
St.Joseph's Healthcare Hamilton
Hamilton, Ontario L8N 4A6
Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec H1T 2M4
Canada
CIC Mauricie inc.
Québec, Quebec G8T 7A1
Canada
Diex Recherche Inc. - Division Sherbrooke Est
Sherbrooke, Quebec J1E 0N8
Canada
Royal University Hospital
Saskatoon, Saskatchewan S7N 0W8
Canada
Centro de Investigacion Curico
Curicó, Maule Region 3341643
Chile
CEC Centro Estudios Clinicos
Santiago, Santiago Metropolitan 7550495
Chile
Fundacion Medica San Cristobal
Santiago, Santiago Metropolitan 7630226
Chile
Biocinetic Ltda.
Santiago, Santiago Metropolitan 8320000
Chile
Centro Respiratorio Integral LTDA. (CENRESIN)
Quillota, Valparaiso 2260000
Chile
Centro de Investigación de Enfermedades Respiratorias e Inmunológicas (CIERI)
Viña del Mar, Valparaiso 2520000
Chile
Hôpital Avicennes
Bobigny, 93000
France
Hospices civils de Lyon - Hôpital Louis Pradel
Bron, 69500
France
CHU Caen Normandie
Caen, 14000
France
Assistance Publique Hôpitaux de Marseille - centre Hospitalier Régional de Marseille
Marseille,
France
Rouen University Hospital
Rouen, 7600
France
Centre Hospitalier Régional Universitaire de Tours
Tours, Tours Cedex 9
France
RoMed Klinikum Rosenheim-Ellmaierstr. 23
Rosenheim, Bavaria 83022
Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony 30625
Germany
Zentralklinik Bad Berka GmbH Klinik für Pneumologie, Zentrum für Schlaf-und Beatmungsmedizin
Bad Berka, 99437
Germany
Prufstelle der GWT am Fachkrankenhaus Coswig
Coswig, 01640
Germany
uhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376
Germany
SLK Kliniken Heilbronn GmbH
Löwenstein, 74245
Germany
LMU Klinikum Medizinische Klinik und Poliklinik V
München, 81377
Germany
Barzilai Medical Center
Ashkelon, 7830604
Israel
Hillel Yaffe Medical Center
Hadera, 3846201
Israel
Rabin Medical Center
Haifa, 3436212
Israel
Shaare Zedek Medical Center
Jerusalem, 9103102
Israel
The Hadassah University Medical Center Ein Kerem Hospital
Jerusalem, 9112001
Israel
Meir Medical Center
Kfar Saba, 4428164
Israel
Rabin Medical Center
Petah Tikva, 4941492
Israel
Kaplan Medical Center
Rehovot, 7551041
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Israel
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Presidio Ospedaliero Gaspare Rodolico
Catania, 95123
Italy
Azienda Unita Sanitaria Locale Della Romagna Ospedale "Gian Battista Morgagni - Luigi Pierantoni" di Forlì
Forlì, 47121
Italy
Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena
Modena, 41124
Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza,
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 168
Italy
Azienda Ospedaliero-Universitaria Senese
Siena, 53100
Italy
Centro Ricerche Cliniche di Verona SrL Pneumology Unit
Verona, 37134
Italy
Canterbury Respiratory Research Group
Christchurch, Canterbury 8011
New Zealand
Aotearoa Clinical Trials Trust- Middlemore Hospital
Auckland,
New Zealand
Waikato Hospital
Hamilton, 3204
New Zealand
Hospital Nacional Adolfo Guevara Velasco
Cusco, 08002
Peru
Clinica Internacional - Sede Lima
Lima, 15001
Peru
Unidad de Investigacion de Enfermedades Respiratorias- Clinica San Pablo -Surco
Lima, 15023
Peru
Clinica Ricardo Palma
Lima, 15036
Peru
Hospital Central de la Fuerza Aerea del Peru
Lima, 15046
Peru
Centro de Investigacion de Enfermedades Respiratorias - Clinica Providencia
Lima, 15088
Peru
Gachon University Gil Medical Center
Incheon, 21565
South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620
South Korea
Korea University Anam Hospital
Seoul, 02841
South Korea
Asan Medical Center
Seoul, 05505
South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 3312
South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taiwan
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
Birmingham Heartlands Hospital
Birmingham,
United Kingdom
Royal Papworth Hospital
Cambridge, CB2 0AY
United Kingdom
NHS Lothian, Royal INfirmary of Edingburgh
Edinburgh, EH16 4SA
United Kingdom
Guy's Hospital
London, SE1 9RT
United Kingdom
Manchester University NHS Foundation Trust, North Manchester General Hospital
Manchester, M8 5RB
United Kingdom
NHS Tayside, Perth Royal Infirmary
Perth, PH1 1NX
United Kingdom