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NCT04905693Enrolling by invitationPhase 3

Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

An Open-label Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease (TETON-OLE)

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.

Status (registry)
Enrolling by invitation
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1850 (estimated)
First submitted
20 May 2021
Start date
Sept 2022
Primary completion date
Dec 2029
Lead sponsor
United Therapeutics
NCT number
NCT04905693

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1850
  • From Sept 2022 to the primary completion date, Dec 2029
  • 192 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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). Subjects participating in non-interventional, observational, or registry studies are eligible.

Other

  • Subject is pregnant or lactating.
  • In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.

Who the study is looking for

  • Subject gives voluntary informed consent to participate in the study.
  • The subject participated in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 at the time that the study or study subject was discontinued by the Sponsor for reasons other than safety.
  • Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit) and non-lactating, and will agree to 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.
  • Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
  • 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.

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (192)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Médico Dra de Salvo
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Buenos AiresArgentinaUnknown status
CINME S.A. - Centro de Investigaciones Metabólicas
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Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Sanatorio Allende Cerro
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CórdobaArgentinaUnknown status
Instituto Ave Pulmo-Fundacion Enfisema
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Mar del PlataArgentinaUnknown status
Centro Médico INSARES
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MendozaArgentinaUnknown status
Instituto Médico Río Cuarto
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Río CuartoArgentinaUnknown status
Sanatorio Parque de Rosario - Consultorios Externos
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RosarioArgentinaUnknown status
Investigaciones en Patologias Respiratorias
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San Miguel de TucumánArgentinaUnknown status
Centro Integral de Medicina Respiratoria - CIMER
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San Miguel de TucumánArgentinaUnknown status
Cairns Hospital
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CairnsAustraliaUnknown status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
Lung Research QLD
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ChermsideAustraliaUnknown status
The Prince Charles Hospital
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ChermsideAustraliaUnknown status
St George Hospital
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KogarahAustraliaUnknown status
Macquarie University
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Macquarie ParkAustraliaUnknown status
Alfred Health
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MelbourneAustraliaUnknown status
Mater Misericordiae Ltd
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South BrisbaneAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
vzw AZORG - Aalst - Moorselbaan
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AalstBelgiumUnknown status
Hopital Erasme
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AnderlechtBelgiumUnknown status
Ziekenhuis Aan De Stroom
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AntwerpBelgiumUnknown status
Cliniques universitaires Saint-Luc
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BrusselsBelgiumUnknown status
UZ Leuven
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LeuvenBelgiumUnknown status
CHU de Liège
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LiègeBelgiumUnknown status
CHR de la Citadelle
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LiègeBelgiumUnknown status
CHU UCL Namur - Site Godinne
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YvoirBelgiumUnknown status
Dynamic Drug Advancement Limited
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AjaxCanadaUnknown status
St. Joseph's Healthcare Hamilton
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HamiltonCanadaUnknown status
Institut universitaire de cardiologie et de pneumologie de Québec
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QuébecCanadaUnknown status
Toronto General Hospital
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TorontoCanadaUnknown status
Centre d'investigation Clinique Mauricie
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Trois-RivièresCanadaUnknown status
St. Paul's Hospital
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VancouverCanadaUnknown status
Centro Respiratorio Integral Limitada
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QuillotaChileUnknown status
CEC Centro de Estudios Clínicos
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SantiagoChileUnknown status
Instituto Nacional del Tórax
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SantiagoChileUnknown status
Fundacion Medica San Cristobal
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SantiagoChileUnknown status
Centro de Investigación del Maule SpA
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TalcaChileUnknown status
Zentralklinik Bad Berka GmbH Klinik für Pneumologie
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Bad BerkaGermanyUnknown status
Prufstelle der GWT am Fachkrankenhaus Coswig
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CoswigGermanyUnknown status
Universitätsmedizin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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EssenGermanyUnknown status
SLK Kliniken Heilbronn GmbH Standort Fachklink Löwenstein Med. Klinik I Pneumologie Beatmungsmedizin Intensivmedizin
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LöwensteinGermanyUnknown status
LMU Klinikum der Universität München
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MünchenGermanyUnknown status
RoMed Klinikum Rosenheim
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RosenheimGermanyUnknown status
Aarhus University Hospital - Department of Respiratory Diseases and Allergy, Research Unit
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Aarhus NDenmarkUnknown status
Gentofte Hospital - Lungemedicinsk forskningsafdeling
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HellerupDenmarkUnknown status
Odense University Hospital - Department of Respiratory Medicine
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Odense CDenmarkUnknown status
Hospital Universitario Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital Universitario Virgen de las Nieves
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GranadaSpainUnknown status
Hospital Universitario de Bellvitge
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Clínico San Carlos
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MadridSpainUnknown status
Hospital General Universitario Gregorio Marañón
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MadridSpainUnknown status
Hospital Universitario de la Princesa
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MadridSpainUnknown status
Hospital Universitario Virgen de la Victoria
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MálagaSpainUnknown status
Hospital Clínico Universitario Virgen de la Arrixaca
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MurciaSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Hospital Universitario Son Espases
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Palma de MallorcaSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
Hospital Clínico Universitario de Santiago de Compostela
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Santiago de CompostelaSpainUnknown status
Chu Amiens Picardie
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AmiensFranceUnknown status
AP-HP Hôpital Avicenne
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BobignyFranceUnknown status
Hospices Civils De Lyon - Université Hospital of Lyon
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BronFranceUnknown status
Chu Caen Normandie
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CaenFranceUnknown status
Hopital Nord AP-HM (Assistance Publique Hôpitaux De Marseille - Centre Hospitalier Régional de Marseille
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MarseilleFranceUnknown status
AP-HP Hopital Europeen Georges Pompidou
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ParisFranceUnknown status
Hôptial Bichat
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ParisFranceUnknown status
Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
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ReimsFranceUnknown status
Hôpital Pontchaillou
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RennesFranceUnknown status
CHU Rouen Hopital Charles Nicolle
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RouenFranceUnknown status
Hopital Larrey
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ToulouseFranceUnknown status
Hopital Bretonneau
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ToursFranceUnknown status
Barzilai Medical Center
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AshkelonIsraelUnknown status
Hillel Yaffe Medical Center
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HaderaIsraelUnknown status
Lady Davis Carmel Medical Center
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HaifaIsraelUnknown status
Hadassah Medical Center PPDS -
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JerusalemIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
Rabin Medical Center - PPDS
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Petah TikvaIsraelUnknown status
Sheba Medical Center - PPDS
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Ramat GanIsraelUnknown status
Kaplan Medical Center
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RehovotIsraelUnknown status
Tel Aviv Sourasky Medical Center PPDS
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyUnknown status
A.O.U. Policlinico Vittorio Emanuele presidio "G.Rodolico"
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CataniaItalyUnknown status
Presidio Ospedaliero GB Morgagni L Pierantoni
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ForlìItalyUnknown status
Gruppo MultiMedica SpA - Ospedale San Giuseppe
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MilanItalyUnknown status
Azienda Ospedaliero - Universitaria di Modena Policlinico
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ModenaItalyUnknown status
Fondazione PTV - POLICLINICO TOR VERGATA
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RomaItalyUnknown status
Fondazione Policlinico Universitario A Gemelli-Rome
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RomeItalyUnknown status
Azienda Ospedaliero Universitaria Senese
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SienaItalyUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
CHA Bundang Medical Center, CHA University
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Seongnam-siSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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SeoulSouth KoreaUnknown status
SMG-SNU Boramae Medical Center
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SeoulSouth KoreaUnknown status
Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas
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Mexico CityMexicoUnknown status
Unidad de Investigacion Clinica en Medicina, S.C.
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MonterreyMexicoUnknown status
Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas (CEPREP)
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MonterreyMexicoUnknown status
Zuyderland Medisch Centrum - Heerlen
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HeerlenNetherlandsUnknown status
Erasmus MC -Dr. Molewaterplein 40
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RotterdamNetherlandsUnknown status
Canterbury Respiratory Research Group
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ChristchurchNew ZealandUnknown status
Waikato Hospital
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HamiltonNew ZealandUnknown status
Hospital Nacional Adolfo Guevara Velasco - Red Asistencial Cusco
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CuscoPeruUnknown status
Clinica Ricardo Palma
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LimaPeruUnknown status
Hospital Central de la Fuerza Aerea del Peru
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LimaPeruUnknown status
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
E-DA Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Far Eastern Memorial Hospital
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New Taipei CityTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
University of New Mexico Health Sciences Center
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AlbuquerqueUnited StatesUnknown status
University of Michigan Int Med Pulmonary and Critical Care
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Ann ArborUnited StatesUnknown status
Piedmont Healthcare - Atlanta
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AtlantaUnited StatesUnknown status
Emory University
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AtlantaUnited StatesUnknown status
Johns Hopkins Asthma and Allergy Center
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BaltimoreUnited StatesUnknown status
The University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Tufts Medical Center
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BostonUnited StatesUnknown status
Brigham and Women's Hospital
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BostonUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
University of Virginia Health Systems
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CharlottesvilleUnited StatesUnknown status
The Lung Research Center, LLC
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ChesterfieldUnited StatesUnknown status
Northwestern Memorial Hospital
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ChicagoUnited StatesUnknown status
University of Cincinnati Medical Center
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CincinnatiUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Prisma Health Midlands
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ColumbiaUnited StatesUnknown status
The Ohio State University -Wexner Medical Center
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ColumbusUnited StatesUnknown status
Stony Brook Advanced Specialty Care
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CommackUnited StatesUnknown status
Baylor University Medical Center
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DallasUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
National Jewish Health
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DenverUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Inova Fairfax Hospital
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Falls ChurchUnited StatesUnknown status
Clinical Trials Center of Middle Tennessee
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FranklinUnited StatesUnknown status
University of Florida Health at Shands
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GainesvilleUnited StatesUnknown status
PulmonIx, LLC
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GreensboroUnited StatesUnknown status
East Carolina University
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GreenvilleUnited StatesUnknown status
Penn State Milton S. Hershey Medical Center
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HersheyUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
The University of Texas Health Science Center at Houston
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HoustonUnited StatesUnknown status
The University of Texas Health Science Center at Houston- McGovern Medical School
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HoustonUnited StatesUnknown status
Houston Methodist
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HoustonUnited StatesUnknown status
University Mississippi Medical Center
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JacksonUnited StatesUnknown status
Mayo Clinic Florida
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JacksonvilleUnited StatesUnknown status
Ascension St. Vincent's
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JacksonvilleUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
Pulmonary Disease Specialists, PA d/b/a PDS Research
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KissimmeeUnited StatesUnknown status
StatCare Pulmonary Consultants, PLLC
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KnoxvilleUnited StatesUnknown status
UC San Diego Health
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La JollaUnited StatesUnknown status
David Geffen School of Medicine at UCLA
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Los AngelesUnited StatesUnknown status
University of Louisville Healthcare Outpatient Center
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LouisvilleUnited StatesUnknown status
Norton Pulmonary Specialists
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LouisvilleUnited StatesUnknown status
University Hospital and UW Health Clinics
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MadisonUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
A & A Research Consultants, LLC
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McAllenUnited StatesUnknown status
Metroplex Pulmonary and Sleep Center, PA
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McKinneyUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
Intermountain Healthcare
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MurrayUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Northwell Health
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New Hyde ParkUnited StatesUnknown status
Tulane University Medical Center
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New OrleansUnited StatesUnknown status
NewportNativeMD, Inc.
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Newport BeachUnited StatesUnknown status
Weill Cornell Medical Center
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New YorkUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Creighton University Clinical Research Office
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OmahaUnited StatesUnknown status
Central Florida Pulmonary Group, PA
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OrlandoUnited StatesUnknown status
Hospital of the University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Thomas Jefferson,Hospital University
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PhiladelphiaUnited StatesUnknown status
Temple University Hospital
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PhiladelphiaUnited StatesUnknown status
Banner-University Medical Center Phoenix
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PhoenixUnited StatesUnknown status
St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
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PhoenixUnited StatesUnknown status
The Oregon Clinic
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PortlandUnited StatesUnknown status
Pulmonary Associates of Richmond, Inc.
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RichmondUnited StatesUnknown status
University of Rochester Medical Center
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RochesterUnited StatesUnknown status
Mayo Clinic, Division of Pulmonary and Critical Care Medicine
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RochesterUnited StatesUnknown status
Clinical Research of Rock Hill
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Rock HillUnited StatesUnknown status
Corewell Health William Beaumont Hospital
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Royal OakUnited StatesUnknown status
UC Davis Health Medical Center
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SacramentoUnited StatesUnknown status
University Of Utah Health
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Salt Lake CityUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
LSU Health Science Center Shreveport
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ShreveportUnited StatesUnknown status
Adventist HealthCare White Oak Medical Center
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Silver SpringUnited StatesUnknown status
Stanford University School of Medicine
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StanfordUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
University of South Florida Health
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TampaUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Renovatio Clinical
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The WoodlandsUnited StatesUnknown status
University of Arizona
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TucsonUnited StatesUnknown status
Cleveland Clinic Florida
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WestonUnited StatesUnknown status
Southeastern Research Center
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.