Inhaled treprostinil aims to slow lung decline in fibrosis trial
NCT ID NCT05943535
First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 4 times
Summary
This phase 3 study tests whether an inhaled drug called treprostinil can slow the worsening of lung function in people with progressive pulmonary fibrosis, a condition where lung scarring gets worse over time. About 698 adults will receive either the drug or a placebo four times daily for 52 weeks. The main goal is to see if the drug helps maintain the amount of air they can exhale forcefully.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inhaled treprostinil (Tyvaso)
- What this could lead to
- If it works, this could provide a new treatment to slow lung function decline and reduce hospitalizations in people with progressive pulmonary fibrosis.
- What could go wrong
- This is a phase 3 trial, but the drug may not prove effective or could cause side effects like cough or headache. Results may not apply to all forms of lung fibrosis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 698 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject gives voluntary informed consent to participate in the study. 2. Subject is ≥18 years of age, inclusive, at the time of signing informed consent. 3. Subject has radiological evidence of pulmonary fibrosis of \>10% extent on an HRCT scan in the previous 12 months (confirmed by central review). 4. Subject has a diagnosis of PPF (other than IPF) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator: 1. Clinically significant decline in % predicted FVC based on ≥10% relative decline 2. Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms 3. Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with increasing extent of fibrotic changes on chest imaging 4. Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging 5. FVC ≥45% predicted at Screening (confirmed by central review). 6. Subjects must be on 1 of the following: 1. On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study 2. Not on treatment with nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, not planning to initiate either treatment during the study. Concomitant use of both nintedanib and pirfenidone is not permitted. 7. Subjects treated with immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids, rituximab) need to be on treatment for at least 120 days prior to Baseline and, in the Investigator's clinical opinion, must be refractory to treatment. 8. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will agree to do 1 of the following: 1. Abstain from intercourse (when it is in line with their preferred and usual lifestyle) 2. Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug. i. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide. Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential. 9. 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. 10. 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 (forced expiratory volume in 1 second/FVC \<0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review). 3. Subject has a diagnosis of IPF. 4. 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. 5. 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), soluble guanylate cyclase stimulators, or activin signaling inhibitors (sotatercept) 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 prior to any study-related efficacy assessments. 6. Subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline. 7. Exacerbation of ILD 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 ILD or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible. 8. Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline. 9. 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. 10. Acute pulmonary embolism within 90 days prior to Baseline. 11. 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. 12. In the opinion of the Investigator, life expectancy \<12 months due to ILD or a concomitant illness. 13. Subject has received nerandomilast within 60 days prior to Baseline.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Interstitial lung disease are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
165 sites in 15 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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A & A Research Consultants, LLC
RECRUITINGMcAllen, Texas, 78503, United States
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AZORG
RECRUITINGAalst, 9300, Belgium
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Adventist Healthcare White Oak Medical Center
RECRUITINGSilver Spring, Maryland, 20904, United States
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Aotearoa Clinical Trials Trust- Middlemore Hospital
RECRUITINGAuckland, New Zealand
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Ascension Medical Group St. Vincent's Lung Institute
RECRUITINGJacksonville, Florida, 32204, United States
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Assistance Publique Hôpitaux de Marseille - centre Hospitalier Régional de Marseille
RECRUITINGMarseille, France
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Austin Health
RECRUITINGHeidelberg, Victoria, 3084, Australia
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Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Presidio Ospedaliero Gaspare Rodolico
RECRUITINGCatania, 95123, Italy
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Azienda Ospedaliero-Universitaria Senese
RECRUITINGSiena, 53100, Italy
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Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena
RECRUITINGModena, 41124, Italy
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Azienda Unita Sanitaria Locale Della Romagna Ospedale "Gian Battista Morgagni - Luigi Pierantoni" di Forlì
RECRUITINGForlì, 47121, Italy
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Banner University Medical Center Phoenix Lung Institute
RECRUITINGPhoenix, Arizona, 85006, United States
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Barzilai Medical Center
RECRUITINGAshkelon, 7830604, Israel
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Baylor University Medical Center
RECRUITINGDallas, Texas, 75246, United States
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Beaumont Hospital, Royal Oak
RECRUITINGRoyal Oak, Michigan, 48073, United States
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Biocinetic Ltda.
RECRUITINGSantiago, Santiago Metropolitan, 8320000, Chile
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Birmingham Heartlands Hospital
RECRUITINGBirmingham, United Kingdom
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CEC Centro Estudios Clinicos
RECRUITINGSantiago, Santiago Metropolitan, 7550495, Chile
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CHU Caen Normandie
RECRUITINGCaen, 14000, France
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CHU de Liège
RECRUITINGLiège, 4000, Belgium
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CIC Mauricie inc.
RECRUITINGQuébec, Quebec, G8T 7A1, Canada
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CIMER-Centro Integral de Medicina Respiratoria
RECRUITINGSan Miguel de Tucumán, Tucumán Province, Argentina
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CINME Centro de Investigaciones Metabolicas
RECRUITINGBuenos Aires, C1056ABI, Argentina
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CUB Hopital Erasmde
RECRUITINGBrussels, 1070, Belgium
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Canterbury Respiratory Research Group
RECRUITINGChristchurch, Canterbury, 8011, New Zealand
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Centre Hospitalier Régional Universitaire de Tours
RECRUITINGTours, Tours Cedex 9, France
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Centro Respiratorio Integral LTDA. (CENRESIN)
RECRUITINGQuillota, Valparaiso, 2260000, Chile
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Centro Ricerche Cliniche di Verona SrL Pneumology Unit
RECRUITINGVerona, 37134, Italy
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Centro de Investigacion Curico
RECRUITINGCuricó, Maule Region, 3341643, Chile
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Centro de Investigacion de Enfermedades Respiratorias - Clinica Providencia
RECRUITINGLima, 15088, Peru
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Centro de Investigación de Enfermedades Respiratorias e Inmunológicas (CIERI)
RECRUITINGViña del Mar, Valparaiso, 2520000, Chile
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Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
RECRUITINGKaohsiung City, 83301, Taiwan
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Christopher King, MD
RECRUITINGFalls Church, Virginia, 22042, United States
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Cleveland Clinic Florida
RECRUITINGWeston, Florida, 33331, United States
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Clinica Internacional - Sede Lima
RECRUITINGLima, 15001, Peru
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Clinica Ricardo Palma
RECRUITINGLima, 15036, Peru
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Clinical Trials Center of Middle Tennessee, LLC
RECRUITINGFranklin, Tennessee, 37067, United States
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Cliniques Universitaires St.-Luc
RECRUITINGBrussels, 1200, Belgium
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Corewell Health Grand Rapids Hospitals - Butterworth
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Diex Recherche Inc. - Division Sherbrooke Est
RECRUITINGSherbrooke, Quebec, J1E 0N8, Canada
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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Dynamic Drug Advancement Limited
RECRUITINGAjax, Ontario, L1S 2J5, Canada
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East Carolina University
RECRUITINGGreenville, North Carolina, 27834, United States
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Eastern Health Box Hill Hospital
RECRUITINGBox Hill, Victoria, 3128, Australia
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Fondazione IRCCS San Gerardo dei Tintori
RECRUITINGMonza, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITINGRoma, 168, Italy
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Fundacion Medica San Cristobal
RECRUITINGSantiago, Santiago Metropolitan, 7630226, Chile
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Fundación Respirar
RECRUITINGBuenos Aires, C1426ABP, Argentina
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Gachon University Gil Medical Center
RECRUITINGIncheon, 21565, South Korea
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Georgetown University Hospital
RECRUITINGWashington D.C., District of Columbia, 20007, United States
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Guy's Hospital
RECRUITINGLondon, SE1 9RT, United Kingdom
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Hillel Yaffe Medical Center
RECRUITINGHadera, 3846201, Israel
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Hospices civils de Lyon - Hôpital Louis Pradel
RECRUITINGBron, 69500, France
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Hospital Central de la Fuerza Aerea del Peru
RECRUITINGLima, 15046, Peru
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Hospital Nacional Adolfo Guevara Velasco
RECRUITINGCusco, 08002, Peru
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Hospital of the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Houston Methodist Outpatient Center
RECRUITINGHouston, Texas, 77030, United States
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Hôpital Avicennes
RECRUITINGBobigny, 93000, France
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Hôpital Maisonneuve-Rosemont
RECRUITINGMontreal, Quebec, H1T 2M4, Canada
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Infinity Medical Center
RECRUITINGNorth Dartmouth, Massachusetts, 02747, United States
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Institute for Respiratory Health
RECRUITINGNedlands, Western Australia, 6009, Australia
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Institute for Respiratory Health - Midland
RECRUITINGMidland, Western Australia, 6056, Australia
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Instituto Ave Pulmo - Fundacion enfisema
RECRUITINGMar del Plata, Buenos Aires, 7600, Argentina
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Instituto Medico Rio Cuarto
RECRUITINGRío Cuarto, Córdoba Province, 5800, Argentina
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Instituto de Medicina Respiratoria
RECRUITINGCórdoba, 5003, Argentina
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Intermountain Medical Center
RECRUITINGMurray, Utah, 84107, United States
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Investigaciones en Patologias Respiratorias
RECRUITINGSan Miguel de Tucumán, Tucumán Province, 4000, Argentina
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Jefferson Honickman Center
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Johns Hopkins Asthma and Allergy Center
RECRUITINGBaltimore, Maryland, 21224, United States
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Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITINGKaohsiung City, 807, Taiwan
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Kaplan Medical Center
RECRUITINGRehovot, 7551041, Israel
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Korea University Anam Hospital
RECRUITINGSeoul, 02841, South Korea
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LMU Klinikum Medizinische Klinik und Poliklinik V
RECRUITINGMünchen, 81377, Germany
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Loyola University Medical Center
RECRUITINGMaywood, Illinois, 60153, United States
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Lung Research QLD
RECRUITINGChermside, Queensland, 4032, Australia
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Lungenfachklinik Immenhausen
RECRUITINGImmenhausen, 34376, Germany
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Manchester University NHS Foundation Trust, North Manchester General Hospital
RECRUITINGManchester, M8 5RB, United Kingdom
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226-1222, United States
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Medical University of South Carolina-Nexus
RECRUITINGCharleston, South Carolina, 29425, United States
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Medizinische Hochschule Hannover
RECRUITINGHanover, Lower Saxony, 30625, Germany
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Meir Medical Center
RECRUITINGKfar Saba, 4428164, Israel
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Memorial Hospital at Gulfport
RECRUITINGGulfport, Mississippi, 39501, United States
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Mercy Health St.Vincent Medical Center LLC
RECRUITINGToledo, Ohio, 43608, United States
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Methodist Hospital
RECRUITINGSan Antonio, Texas, 78229, United States
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Metroplex Pulmonary and Sleep Center
RECRUITINGMcKinney, Texas, 75069, United States
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Monash Health-Monash Medical Centre
RECRUITINGClayton, Victoria, 3168, Australia
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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10467, United States
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NHS Lothian, Royal INfirmary of Edingburgh
RECRUITINGEdinburgh, EH16 4SA, United Kingdom
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NHS Tayside, Perth Royal Infirmary
RECRUITINGPerth, PH1 1NX, United Kingdom
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NewportNativeMD, Inc.
RECRUITINGNewport Beach, California, 92663, United States
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Northwell Health
RECRUITINGNew Hyde Park, New York, 11042, United States
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Northwestern Memorial Hospital, Clinical Research Unit
RECRUITINGChicago, Illinois, 60611, United States
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Norton Thoracic Institute
RECRUITINGPhoenix, Arizona, 85013, United States
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Paradigm Clinical Research
RECRUITINGRedding, California, 45227, United States
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Paradigm Clinical Research
RECRUITINGSan Diego, California, 92108, United States
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Pennsylvania State Hershey Medical Center and College of Medicine
RECRUITINGHershey, Pennsylvania, 17033, United States
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Peter Morton Medical Building
RECRUITINGLos Angeles, California, 90095, United States
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Prisma Health Pulmonology-Richland
RECRUITINGColumbia, South Carolina, 29203, United States
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Prufstelle der GWT am Fachkrankenhaus Coswig
RECRUITINGCoswig, 01640, Germany
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PulmonIx LLC
RECRUITINGGreensboro, North Carolina, 27403, United States
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Pulmonary Associates of Richmond, Inc.
RECRUITINGRichmond, Virginia, 23230, United States
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Rabin Medical Center
RECRUITINGHaifa, 3436212, Israel
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Rabin Medical Center
RECRUITINGPetah Tikva, 4941492, Israel
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RoMed Klinikum Rosenheim-Ellmaierstr. 23
RECRUITINGRosenheim, Bavaria, 83022, Germany
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Rouen University Hospital
RECRUITINGRouen, 7600, France
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Royal Papworth Hospital
RECRUITINGCambridge, CB2 0AY, United Kingdom
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Royal Prince Alfred Hospital
RECRUITINGCamperdown, New South Wales, 2050, Australia
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Royal University Hospital
RECRUITINGSaskatoon, Saskatchewan, S7N 0W8, Canada
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Rush University Medical Center Outpatient Pulmonary Clinic
RECRUITINGChicago, Illinois, 60612, United States
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SLK Kliniken Heilbronn GmbH
RECRUITINGLöwenstein, 74245, Germany
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Saint Luke's Hospital of Kansas City
RECRUITINGKansas City, Missouri, 64111, United States
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Sanatorio Allende Cerro
RECRUITINGCórdoba, 5021, Argentina
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Sanatorio Parque de Rosario - Consultorios Externos
RECRUITINGRosario, Santa Fe Province, 2000, Argentina
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Seoul National University Bundang Hospital
RECRUITINGSeongnam-si, 13620, South Korea
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Shaare Zedek Medical Center
RECRUITINGJerusalem, 9103102, Israel
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St George Hospital
RECRUITINGKogarah, New South Wales, 2217, Australia
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St. Luke's Univeristy Health Network-Pulmonary & Critical Care
RECRUITINGCincinnati, Ohio, 45227, United States
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St.Joseph's Healthcare Hamilton
RECRUITINGHamilton, Ontario, L8N 4A6, Canada
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St.Paul's Hospital
RECRUITINGVancouver, British Columbia, V6Z 176, Canada
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Stanford University Medical Center
RECRUITINGStanford, California, 94305, United States
-
StatCare Pulmonary Consultants, PLLC
RECRUITINGKnoxville, Tennessee, 37919, United States
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Stony Brook Advanced Specialty Care
RECRUITINGStony Brook, New York, 11794-8172, United States
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TGH/USF Center for Advanced Lung Disease and Lung Transplant
RECRUITINGTampa, Florida, 33606, United States
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Taichung Veterans General Hospital
RECRUITINGTaichung, 40705, Taiwan
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Tel Aviv Sourasky Medical Center
RECRUITINGTel Aviv, 6423906, Israel
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Temple University Hospital
RECRUITINGPhiladelphia, Pennsylvania, 19140, United States
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The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITINGSeoul, 3312, South Korea
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The Emory Clinic
RECRUITINGAtlanta, Georgia, 45227, United States
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The Hadassah University Medical Center Ein Kerem Hospital
RECRUITINGJerusalem, 9112001, Israel
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The Lung Research Center, LLC
RECRUITINGChesterfield, Missouri, 63017, United States
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The Ohio State University Wexner Medical CEnter
RECRUITINGColumbus, Ohio, 43201, United States
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The Prince Charles Hospital
RECRUITINGBrisbane, Queensland, Australia, Australia
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The University of Texas Health Science Center at Houston, McGovern Medical School
RECRUITINGHouston, Texas, 77030, United States
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The Vanderbilt Lung Institute
RECRUITINGNashville, Tennessee, 37204, United States
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Tufts Medical Center
RECRUITINGBoston, Massachusetts, 02111, United States
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Tulane Medical Center
RECRUITINGNew Orleans, Louisiana, 45227, United States
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UAB Lung Health Center
RECRUITINGBirmingham, Alabama, 35233, United States
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UC Davis Health Medical Center
RECRUITINGSacramento, California, 95817, United States
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UI Health Hospital
RECRUITINGChicago, Illinois, 60612, United States
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UT Southwestern Medical Center-Advanced Lung Clinic
RECRUITINGDallas, Texas, 75390, United States
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UZ Leuven
RECRUITINGLeuven, 3000, Belgium
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Unidad de Investigacion de Enfermedades Respiratorias- Clinica San Pablo -Surco
RECRUITINGLima, 15023, Peru
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Universitair Ziekenhuis Gent
RECRUITINGGhent, 9000, Belgium
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University Hospital and UW Health Clinics
RECRUITINGMadison, Wisconsin, 53792, United States
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University of California Irvine Medical Center
RECRUITINGOrange, California, 92868, United States
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University of Cincinnati Medical Center
RECRUITINGCincinnati, Ohio, 45219, United States
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University of Kansas Medical Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Kentucky
RECRUITINGLexington, Kentucky, 45227, United States
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University of Louisville Healthcare Outpatient Research Clinic
RECRUITINGLouisville, Kentucky, 40202, United States
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University of Maryland Medical Center
RECRUITINGBaltimore, Maryland, 45227, United States
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University of Minnesota Health Clinical Research Unit (CRU)
RECRUITINGMinneapolis, Minnesota, 55455, United States
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University of New Mexico
RECRUITINGAlbuquerque, New Mexico, 87131, United States
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University of Utah Health
RECRUITINGSalt Lake City, Utah, 84108, United States
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University of Virginia Health System
RECRUITINGCharlottesville, Virginia, 22903, United States
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Waikato Hospital
RECRUITINGHamilton, 3204, New Zealand
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Wake Forest Baptist Health
RECRUITINGWinston-Salem, North Carolina, 27104, United States
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
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Weill Cornell Medicine, New York-Presbyterian Hospital
RECRUITINGNew York, New York, 10065, United States
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ZAS Middelheim
RECRUITINGAntwerp, 2020, Belgium
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Zentralklinik Bad Berka GmbH Klinik für Pneumologie, Zentrum für Schlaf-und Beatmungsmedizin
RECRUITINGBad Berka, 99437, Germany
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uhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
RECRUITINGEssen, 45239, Germany
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