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NCT06961214RecruitingPhase 3

Depemokimab as an Extended Treatment Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab in Adult Participants With COPD With Type 2 Inflammation

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
961 (estimated)
First submitted
29 Apr 2025
Start date
23 Jun 2025
Primary completion date
13 Dec 2028
Lead sponsor
GlaxoSmithKline
Diseases
COPD
NCT number
NCT06961214
EU CT number
2024-520417-41-00
EudraCT number
2024-520417-41

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 961
  • From 23 Jun 2025 to the primary completion date, 13 Dec 2028
  • 174 sites in 16 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

  • Participants with a current or prior physician diagnosis of asthma
  • Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1
  • Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1

Other illness

  • Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease
  • Lung resection: Participants with a history of or plan for lung volume reduction surgery / endobronchial valve procedure.
  • Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension
  • Unstable cardiovascular disease or arrhythmia
  • Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)

Other

  • The following subjects are excluded:
  • Continuous oxygen: Participants requiring oxygen supplementation for more than 16 hours per day to maintain resting oxygen saturation greater than 88%
  • Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\])

Who the study is looking for

  • Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the Informed consent
  • Elevated Blood Eosinophil Count (BEC)
  • Moderate to severe COPD with frequent exacerbations, defined as:
    • A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
    • A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of \< 0.70 and a post-bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values
    • A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
  • COPD assessment test (CAT) score \>=10 at Visit 1
  • Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years.
  • Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1
  • Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2)
  • Male and eligible female participants

Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (174)

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

SiteCityCountrySite status
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BerazateguiArgentinaRecruiting
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Buenos AiresArgentinaRecruiting
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CórdobaArgentinaRecruiting
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LobosArgentinaRecruiting
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QuilmesArgentinaRecruiting
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RosarioArgentinaRecruiting
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Rosario Provincia de Santa FEArgentinaRecruiting
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San Miguel de TucumánArgentinaRecruiting
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Santa FeArgentinaRecruiting
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Sante FeArgentinaRecruiting
Medical University of Graz
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GrazAustriaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
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Klagenfurt Am WoertherseeAustriaRecruiting
Private Practice Dr. Michael Würtz - Pulmonologist
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LinzAustriaRecruiting
Ordensklinikum Linz GmbH
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LinzAustriaRecruiting
Johannes Kepler University Linz
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LinzAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
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Coffs HarbourAustraliaRecruiting
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MaroubraAustraliaRecruiting
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MidlandAustraliaRecruiting
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WestmeadAustraliaRecruiting
Asclepius Medical Center OOD
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DupnitsaBulgariaRecruiting
Medical Center Pulmo - 2018 EOOD
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HaskovoBulgariaRecruiting
Medical Centre Pratia Clinic EOOD
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LovechBulgariaRecruiting
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
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MontanaBulgariaRecruiting
Medical Center Hera EOOD
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MontanaBulgariaRecruiting
Specializirana Bolnica Za Aktivno Lechenie Na Pnevmo-Ftiziatrichni Zaboliavania Dr Nikola Penchev-Pazardzhik EOOD
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PazardzhikBulgariaRecruiting
Medical Center Medconsult Pleven OOD
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PlevenBulgariaRecruiting
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
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RuseBulgariaRecruiting
Medical Center Hermes Ruse Ltd.
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RuseBulgariaRecruiting
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
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SofiaBulgariaRecruiting
Medical Center Hera EOOD
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SofiyaBulgariaRecruiting
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD
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SofiyaBulgariaRecruiting
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaRecruiting
MEDITRIAL s.r.o.
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Jindrichuv Hradec IIICzechiaRecruiting
Nemocnice Nymburk s.r.o.
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NymburkCzechiaRecruiting
Synexus Czech s.r.o.
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PragueCzechiaRecruiting
Plicni ambulance Kralupy s.r.o.
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PragueCzechiaRecruiting
PNEUMOLOGIE VARNSDORF s.r.o.
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VarnsdorfCzechiaRecruiting
KPPK GmbH
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BendorfGermanyRecruiting
Praxis an der Oper
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BerlinGermanyRecruiting
MECS Research GmbH
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BerlinGermanyRecruiting
Pneumologisches Studienzentrum MVZ die Lungenärzte Gesundheitszentrum
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BerlinGermanyRecruiting
Clinical Studies Pankow Ishak Teber
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BerlinGermanyRecruiting
Lungenarztpraxis Hellersdorf
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BerlinGermanyRecruiting
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
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BerlinGermanyRecruiting
Lungenpraxis Hohenzollerndamm
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BerlinGermanyRecruiting
Pneumo Studien Darmstadt GmbH
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DarmstadtGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Praxis für Pneumologie
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FürstenwaldeGermanyRecruiting
Pneumologisches Forschungszentrum Hohegeest GbR
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GeesthachtGermanyRecruiting
Agaplesion Evangelisches Krankenhaus Mittelhessen gGmbH
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GiessenGermanyRecruiting
Pneumologicum Halle Dr. med. Peter-Uwe Haase
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HalleGermanyRecruiting
Universitaetsklinikum des Saarlandes AöR
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HomburgGermanyRecruiting
Lungenfachklinik Immenhausen
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ImmenhausenGermanyRecruiting
Salvus-Klinische Studien GmbH
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LeipzigGermanyRecruiting
POIS Sachsen GmbH
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LeipzigGermanyRecruiting
Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
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LeipzigGermanyRecruiting
Velocity Clinical Research Germany GmbH
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LuebeckGermanyRecruiting
Lungenärzte am Rundfunkplatz
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MünchenGermanyRecruiting
FutureMeds GmbH
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Offenbach Am MainGermanyRecruiting
framol-med GmbH
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RheineGermanyRecruiting
Siteworks GmbH
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SchleswigGermanyRecruiting
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BedfordUnited KingdomRecruiting
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CorbyUnited KingdomRecruiting
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DagenhamUnited KingdomRecruiting
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EdinburghUnited KingdomRecruiting
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GlasgowUnited KingdomRecruiting
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LlanelliUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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ManchesterUnited KingdomRecruiting
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OxfordUnited KingdomRecruiting
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PortsmouthUnited KingdomRecruiting
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SalfordUnited KingdomRecruiting
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UxbridgeUnited KingdomRecruiting
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceRecruiting
Athens Naval Hospital
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AthensGreeceRecruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceRecruiting
University General Hospital of Ioannina
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IoanninaGreeceRecruiting
Athens Medical Center S.A.
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MaroussiGreeceRecruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceRecruiting
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AshkelonIsraelRecruiting
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BeershebaIsraelRecruiting
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Beer-YaakovIsraelRecruiting
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HaderaIsraelRecruiting
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HaifaIsraelRecruiting
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JerusalemIsraelRecruiting
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Kfar SabaIsraelRecruiting
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Petah TikvaIsraelRecruiting
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Ramat GanIsraelRecruiting
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Tel AvivIsraelRecruiting
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
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BariItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyRecruiting
University Hospital Of Ferrara
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FerraraItalyRecruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyRecruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Università Campus Bio-Medico di Roma
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RomeItalyRecruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Istituti Clinici Scientifici Maugeri S.p.A. Societa' Benefit In Forma Abbreviata Istituti Clinici Scientifici Maugeri S.p.A. Sb O Anche Ics Maugeri S.p.A. Sb O Maugeri S.p.A. Sb
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Telese TermeItalyRecruiting
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DaeguSouth KoreaRecruiting
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IncheonSouth KoreaRecruiting
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JeonjuSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
Veselibas centru apvieniba AS
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DaugavpilsLatviaRecruiting
Pauls Stradins Clinical University Hospital
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RigaLatviaRecruiting
Rigas Austrumu kliniska universitates slimnica SIA
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RigaLatviaRecruiting
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AucklandNew ZealandRecruiting
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ChristchurchNew ZealandRecruiting
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EbdentownNew ZealandRecruiting
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HamiltonNew ZealandRecruiting
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RotoruaNew ZealandRecruiting
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TakapunaNew ZealandRecruiting
Spitalul De Pneumoftiziologie Bacau
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BacauRomaniaRecruiting
Anima Specialty Medical Services S.R.L.
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BucharestRomaniaRecruiting
Cabinet Medical de Pneumologie Bogdan Mihai Mincu
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Cluj NapocaRomaniaRecruiting
Spitalul Clinic de Pneumoftiziologie Leon Daniello
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Cluj-NapocaRomaniaRecruiting
Spital De Pneumologie Dr. Lavinia Davidescu S.R.L.
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OradeaRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta Bihor
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OradeaRomaniaRecruiting
Spitalul Clinic De Pneumoftiziologie Constanta
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Palazu MareRomaniaRecruiting
Cabinet Medical Pneumologie Pneumo Bronho Med Dr. Vancea Dorin
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Timisoara, TimisRomaniaRecruiting
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Chiang MaiThailandRecruiting
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AdairsvilleUnited StatesRecruiting
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Allen ParkUnited StatesRecruiting
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AtlantaUnited StatesRecruiting
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AuroraUnited StatesRecruiting
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AustinUnited StatesRecruiting
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BangorUnited StatesRecruiting
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Baton RougeUnited StatesRecruiting
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BoiseUnited StatesRecruiting
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BrooksvilleUnited StatesRecruiting
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ChicagoUnited StatesRecruiting
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CordeleUnited StatesRecruiting
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DallasUnited StatesRecruiting
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DetroitUnited StatesRecruiting
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DoralUnited StatesRecruiting
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DuBoisUnited StatesRecruiting
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El PasoUnited StatesRecruiting
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Fall RiverUnited StatesRecruiting
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Fort LauderdaleUnited StatesRecruiting
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Garden CityUnited StatesRecruiting
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HoustonUnited StatesRecruiting
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KnoxvilleUnited StatesRecruiting
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LafayetteUnited StatesRecruiting
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LampasasUnited StatesRecruiting
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Las VegasUnited StatesRecruiting
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MiamiUnited StatesRecruiting
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Miami LakesUnited StatesRecruiting
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MoorestownUnited StatesRecruiting
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MorgantownUnited StatesRecruiting
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MorrowUnited StatesRecruiting
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Mount KiscoUnited StatesRecruiting
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NaplesUnited StatesRecruiting
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New Port RicheyUnited StatesRecruiting
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New WindsorUnited StatesRecruiting
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OcalaUnited StatesRecruiting
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OrlandoUnited StatesRecruiting
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Ormond BeachUnited StatesRecruiting
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Palmetto BayUnited StatesRecruiting
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Pembroke PinesUnited StatesRecruiting
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PhiladelphiaUnited StatesRecruiting
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RichmondUnited StatesRecruiting
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RockvilleUnited StatesRecruiting
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San AntonioUnited StatesRecruiting
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SewellUnited StatesRecruiting
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SheffieldUnited StatesRecruiting
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ShelbyUnited StatesRecruiting
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ShreveportUnited StatesRecruiting
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SpartanburgUnited StatesRecruiting
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St. PetersburgUnited StatesRecruiting
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TroyUnited StatesRecruiting
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UnionUnited StatesRecruiting
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WebsterUnited StatesRecruiting

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