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NCT05037929CompletedPhase 2

A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
1334 (actual)
First submitted
31 Aug 2021
Start date
Oct 2021
Primary completion date
Feb 2025
Lead sponsor
Genentech, Inc.
Diseases
COPD
NCT number
NCT05037929

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 1334
  • From Oct 2021 to the primary completion date, Feb 2025
  • 192 sites in 24 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

  • Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
  • History of long-term treatment with oxygen at \>4.0 liters/minute
  • Lung volume reduction surgery or procedure within 12 months prior to screening
  • Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
  • Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
  • Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks prior to screening
  • Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

Other illness

  • History of clinically significant pulmonary disease other than COPD
  • History of lung transplant

Other

  • Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible

Who the study is looking for

  • Documented physician diagnosis of COPD for at least 12 months
  • History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
  • Post-bronchodilator FEV1 \>=20 and \<80% of predicted normal value at screening
  • Modified Medical Research Council (dyspnea scale) (mMRC) score \>=2
  • Current or former smoker with a minimum of 10 pack-year history
  • History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA

Age in the registry: 40 years to 90 years · 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
Fundacion Cidea
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Buenos AiresArgentinaUnknown status
Centro de Investigaciones Clínicas Belgrano
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Buenos AiresArgentinaUnknown status
Centro Médico Dra de Salvo
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Buenos AiresArgentinaUnknown status
Instituto de Investigaciones Clinicas-Mar del Plata
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Buenos AiresArgentinaUnknown status
Care: Centro de Alergia Y Enfermedades Respiratorias
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CABAArgentinaUnknown status
Instituto de Medicina Respiratoria - Imer
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CórdobaArgentinaUnknown status
Centro de Especialidades Medicas Lobos
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LobosArgentinaUnknown status
Instituto Ave Pulmo
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Mar del PlataArgentinaUnknown status
Centro de Investigaciones Medicas Mar Del Plata
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Mar del PlataArgentinaUnknown status
Fundacion Scherbovsky
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MendozaArgentinaUnknown status
INSARES
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MendozaArgentinaUnknown status
Centro Respiratorio Quilmes
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QuilmesArgentinaUnknown status
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
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RosarioArgentinaUnknown status
Centro Medico IPAM
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RosarioArgentinaUnknown status
Centro Médico Respire
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San FernandoArgentinaUnknown status
Instituto De Enfermedades Respiratorias E Investigacion Medica
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San Juan BautistaArgentinaUnknown status
Centro Integral de Medicina Respiratoria - CIMER
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San Miguel de TucumánArgentinaUnknown status
Investigaciones en Patologias Respiratorias
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San Miguel de TucumánArgentinaUnknown status
Flinders Medical Centre
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Bedford ParkAustraliaUnknown status
Box Hill Hospital
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Box HillAustraliaUnknown status
TrialsWest Pty Ltd
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SpearwoodAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
UZ Antwerpen
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EdegemBelgiumUnknown status
Private Practice Dr Jean Benoit Martinot
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ErpentBelgiumUnknown status
UZ Leuven Gasthuisberg
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LeuvenBelgiumUnknown status
AZ Sint Maarten
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MechelenBelgiumUnknown status
AZ Delta
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RoeselareBelgiumUnknown status
Office of Marc De Meulemeester
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ThuinBelgiumUnknown status
CHU UCL Namur asbl - Site Godinne
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YvoirBelgiumUnknown status
Medical Centre "Asklepii", OOD
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DupnitsaBulgariaUnknown status
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
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HaskovoBulgariaUnknown status
Medical center Vip Clinic OOD
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LovechBulgariaUnknown status
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Dr.Nikola Penchev-Paza
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PazardzhikBulgariaUnknown status
Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
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PernikBulgariaUnknown status
Medical Center Medconsult Pleven OOD
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PlevenBulgariaUnknown status
Medical center Unimed EOOD
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PlovdivBulgariaUnknown status
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
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PlovdivBulgariaUnknown status
Medical Centre Respiro OOD
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RazgradBulgariaUnknown status
Medical Center Hera EOOD
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SofiaBulgariaUnknown status
University Multiprofile Hospital for Active Treatment and Emergency Medicine N I Pirogov EAD
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SofiaBulgariaUnknown status
Medical Center New Rehabilitation Center EOOD
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Stara ZagoraBulgariaUnknown status
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa
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VratsaBulgariaUnknown status
Burlington Lung Clinic
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BurlingtonCanadaUnknown status
St. Joseph's Healthcare Hamilton - Charlton Campus
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HamiltonCanadaUnknown status
Clinique de pneumologie et du sommeil de Lanaudiere
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Saint-Charles-BorroméeCanadaUnknown status
Bluewater Clinical Research Group
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SarniaCanadaUnknown status
University of Saskatchewan, Royal University Hospital
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SaskatoonCanadaUnknown status
Centro de Investigación Curico
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CuricóChileUnknown status
MIRES/MYF estudios clinicos
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ÑuñoaChileUnknown status
Sociedad Médica SyG SpA
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ProvidenciaChileUnknown status
Centro de Investigaciones Medicas Respiratorias
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ProvidenciaChileUnknown status
Enroll SpA - PPDS
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ProvidenciaChileUnknown status
Meditek Ltda.
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SantiagoChileUnknown status
Centro de Investigacion del Maule
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TalcaChileUnknown status
Hospital Carlos Van Buren
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ValparaísoChileUnknown status
MediTrial s.r.o.
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Jind?ich?v HradecCzechiaUnknown status
Plicni Ambulance Kralupy nad Vltavou
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Kralupy nad VltavouCzechiaUnknown status
MUDr. Ilona Pavlisova s.r.o.
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MiroslavCzechiaUnknown status
Pneumologie Varnsdorf S.r.o.
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Nový BorCzechiaUnknown status
KASMED s.r.o.
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TáborCzechiaUnknown status
Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako
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AugsburgGermanyUnknown status
CIMS Studienzentrum Bamberg
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BambergGermanyUnknown status
KPPK Studienzentrum Kroker-Schmidt
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BendorfGermanyUnknown status
Praxis Dr. Med Evelin Liefring
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BerlinGermanyUnknown status
MECS Research GmbH
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BerlinGermanyUnknown status
Gemeinscharftspraxis Dres Jung - Deggingen
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DeggingenGermanyUnknown status
Medizentrum Essen Borbeck
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EssenGermanyUnknown status
Praxis Dr med Claus Keller
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Frankfurt am MainGermanyUnknown status
Universitätsklinikum Gießen und Marburg GmbH
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GiessenGermanyUnknown status
Asklepios MVZ Bayern GmbH
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LandsbergGermanyUnknown status
Salvus-Klinische Studien GmbH
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LeipzigGermanyUnknown status
IKF Pneumologie Mainz
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MainzGermanyUnknown status
Zentrum fuer ambulante pneumologische Forschung Marburg GbR
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MarburgGermanyUnknown status
Studienzentrum Dr Med Schlenska
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PeineGermanyUnknown status
Aalborg Universitetshospital
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AalborgDenmarkUnknown status
Gentofte Hospital
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HellerupDenmarkUnknown status
Hvidovre Hospital
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HvidovreDenmarkUnknown status
Odense Universitetshospital
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OdenseDenmarkUnknown status
Sygehus Lillebælt - Vejle
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VejleDenmarkUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital de San Pedro de Alcantara
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CáceresSpainUnknown status
Hospital Universitario Virgen de las Nieves
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GranadaSpainUnknown status
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainUnknown status
Hospital General Universitario Gregorio Marañón
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MadridSpainUnknown status
Hospital Universitario Virgen de la Victoria
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MálagaSpainUnknown status
Hospital de Mérida
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MéridaSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
CHUS - H. Clinico U. de Santiago
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Santiago de CompostelaSpainUnknown status
Hôpital de la Croix Rousse
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LyonFranceUnknown status
Hôpital Saint Joseph Marseille
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MarseilleFranceUnknown status
CHU de Nice
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NiceFranceUnknown status
Nouvel Hôpital Civil
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StrasbourgFranceUnknown status
Bradford Royal Infirmary
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BradfordUnited KingdomUnknown status
Cambridge University Hospitals NHS Foundation Trust
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CambridgeUnited KingdomUnknown status
Ninewells Hospital
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DundeeUnited KingdomUnknown status
Glenfield Hospital
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LeicesterUnited KingdomUnknown status
Queen Anne Street Medical Centre
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LondonUnited KingdomUnknown status
Tuen Mun Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Assuta Ashdod Medical Center
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AshdodIsraelUnknown status
Barzilai Medical Center
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AshkelonIsraelUnknown status
Shamir Medical Center Assaf Harofeh
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Beer JacobIsraelUnknown status
Tel Aviv Sourasky Medical Center PPDS
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JerusalemIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Rabin Medical Center
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Petach TiqwaIsraelUnknown status
Kaplan Medical Center
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RehovotIsraelUnknown status
Sheba Medical Center - PPDS
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Tel HaShomerIsraelUnknown status
Catholic Univ. of Incheon St.Mary's Hospital
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IncheonSouth KoreaUnknown status
jeonbuk National University Hospital
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JeonjuSouth KoreaUnknown status
Konkuk University Medical Center
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SeoulSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Centro de Investigacion y Atencion Integral Durango CIAID
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DurangoMexicoUnknown status
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
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GuadalajaraMexicoUnknown status
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
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GuadalajaraMexicoUnknown status
Unidad Medica de Occidente
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GuadalajaraMexicoUnknown status
CICUM San Miguel
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Guadalajara CentroMexicoUnknown status
Unidad de Investigacion Clinica En Medicina (Udicem) S.C.
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MonterreyMexicoUnknown status
Amphia Ziekenhuis
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BredaNetherlandsUnknown status
Catharina hospital
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EindhovenNetherlandsUnknown status
Dijklander Ziekenhuis - loc Hoorn
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HoornNetherlandsUnknown status
Isala Klinieken
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ZwolleNetherlandsUnknown status
NZ Respiratory & Sleep Institute
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AucklandNew ZealandUnknown status
Aotearoa Clinical Trials Trust
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AucklandNew ZealandUnknown status
Canterbury Respiratory Research Group
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ChristchurchNew ZealandUnknown status
Clinica Providencia (Inverconsult Sociedad Anonima)
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LimaPeruUnknown status
Clinica Ricardo Palma
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LimaPeruUnknown status
Clinica Internacional
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LimaPeruUnknown status
Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada
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Lima CercadoPeruUnknown status
Centrum Medyczne Bydgoszcz- PRATIA - PPDS
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BydgoszczPolandUnknown status
Indywidualna Specjalistyczna Praktyka Lekarska lek.
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KielcePolandUnknown status
Diamond Clinic
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KrakowPolandUnknown status
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
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KrakowPolandUnknown status
Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED
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KrakowPolandUnknown status
ETG Lodz
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LodzPolandUnknown status
ETG Lublin
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LublinPolandUnknown status
Twoja Przychodnia Centrum Medyczne Nowa Sól
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Nowa SólPolandUnknown status
Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik
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Ostrowiec SwietokrzyskPolandUnknown status
Centrum Alergologii Teresa Hofman
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PoznanPolandUnknown status
EMED Centrum Uslug Medycznych Ewa Smialek
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RzeszówPolandUnknown status
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
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SosnowiecPolandUnknown status
ETG Warszawa - PPDS
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WarsawPolandUnknown status
Ewa Pisarczyk-Bogacka Specjalistyczna Praktyka Lekarska
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WroclawPolandUnknown status
Neomed Out-Patient Treatment and Diagnosis Medical Center SRL
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BrasovRomaniaUnknown status
Dr. Victor Babes Foundation
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BucharestRomaniaUnknown status
Leon Daniello Pneumophthisiology Clinical Hospital
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Cluj-NapocaRomaniaUnknown status
Spitalul Clinic de Pneumoftiziologie Constanta
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ConstanțaRomaniaUnknown status
Sf. Ioan cel Nou Emergency County Hospital
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SuceavaRomaniaUnknown status
Fysikalisk Medicin i Stockholm AB
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LidingöSwedenUnknown status
ProbarE i Lund AB
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LundSwedenUnknown status
Pharmasite
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MalmöSwedenUnknown status
ProbarE i Stockholm AB
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StockholmSwedenUnknown status
South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
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BoerneUnited StatesUnknown status
Northern Pines Health Center PC
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BuckleyUnited StatesUnknown status
American Health Research Inc.
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CharlotteUnited StatesUnknown status
University of Virginia Health System
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CharlottesvilleUnited StatesUnknown status
Cardio-Pulmonary Associates
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ChesterfieldUnited StatesUnknown status
Northwestern Center for Clinical Research
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ChicagoUnited StatesUnknown status
St. Francis Sleep
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ClearwaterUnited StatesUnknown status
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
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DothanUnited StatesUnknown status
MediSphere Medical Research Center, LLC
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EvansvilleUnited StatesUnknown status
Exordia Medical Research Inc
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Fall RiverUnited StatesUnknown status
Clinical Research of Gastonia
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GastoniaUnited StatesUnknown status
Blessing Health Hannibal
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HannibalUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
Jasper Summit Research LLC
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JasperUnited StatesUnknown status
Sierra Clinical Research - ClinEdge - PPDS
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Las VegasUnited StatesUnknown status
Revive Research Institute
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Lathrup VillageUnited StatesUnknown status
Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS
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LeesburgUnited StatesUnknown status
Pulmonary Specialists of the Palm Beaches
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Loxahatchee GrovesUnited StatesUnknown status
Metroplex Pulmonology & Sleep Center
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McKinneyUnited StatesUnknown status
Pulmonary Associates of Mobile PC
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MobileUnited StatesUnknown status
Lowcountry Lung and Critical Care
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North CharlestonUnited StatesUnknown status
Florida Institute For Clinical Research, LLC
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OrlandoUnited StatesUnknown status
Temple University Hospital
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PhiladelphiaUnited StatesUnknown status
Cadena Care Institute, LLC
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PowayUnited StatesUnknown status
Clinical Research of Rock Hill
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Rock HillUnited StatesUnknown status
Midwest Chest Consultants
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Saint CharlesUnited StatesUnknown status
Inst. of Healthcare Assessment, Inc.
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San DiegoUnited StatesUnknown status
Carolina Research Center
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ShelbyUnited StatesUnknown status
Sherman Clinical Research - ClinEdge - PPDS
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ShermanUnited StatesUnknown status
Velocity Clinical Research - Spartanburg - PPDS
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SpartanburgUnited StatesUnknown status
CARE Clinical Research
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St LouisUnited StatesUnknown status
Midwest Clinical Research LLC
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St LouisUnited StatesUnknown status
Oakland Medical Research
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TroyUnited StatesUnknown status
Allianz Research Institute, Inc.
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WestminsterUnited StatesUnknown status
Southeastern Research Center
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Winston-SalemUnited StatesUnknown status
Clinical Site Partners - Winter Park - HyperCore - PPDS
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Winter ParkUnited StatesUnknown status
University of Cape Town Lung Institute
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Cape TownSouth AfricaUnknown status
Clinical Trial Systems
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City of TshwaneSouth AfricaUnknown status
St Augustines Hospital
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DurbanSouth AfricaUnknown status
Lakeview Hospital
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EkurhuleniSouth AfricaUnknown status
Dr A.C Wilhase practice-Reimed
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EkurhuleniSouth AfricaUnknown status
Langeberg Clinical Trials
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KraaifonteinSouth AfricaUnknown status

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