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NCT06883305RecruitingPhase 3

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
990 (estimated)
First submitted
3 Mar 2025
Start date
18 Mar 2025
Primary completion date
13 Mar 2029
Lead sponsor
AstraZeneca
Diseases
COPD
NCT number
NCT06883305
EU CT number
2024-517458-90-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 990
  • From 18 Mar 2025 to the primary completion date, 13 Mar 2029
  • 253 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

  • Tuberculosis requiring treatment within 12 months prior V2
  • Malignancies current or past
    • Concomitant therapies:
    • Macrolides (less than 6 months)
    • Systemic immuno-suppressive, -modulating medications

Other illness

  • Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
  • Any unstable disorder that can impact participants safety or study outcomes

Other

  • Asthma, incl. pediatric, or ACOS
  • LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Who the study is looking for

  • ≥40 to ≤80 years old
  • COPD diagnosis ≥1 year,
  • Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
  • Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
  • ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy
  • EOS ≥ 150 cells/μL during screening
  • CAT ≥15 at screening
  • Former or current smokers ≥10 pack-years

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

Full criteria on ClinicalTrials.gov

Sites (253)

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

SiteCityCountrySite status
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Bragança PaulistaBrazilRecruiting
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BrasíliaBrazilRecruiting
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CampinasBrazilRecruiting
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ChapecóBrazilRecruiting
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CuritibaBrazilRecruiting
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JaúBrazilRecruiting
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MossoróBrazilRecruiting
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Porto AlegreBrazilRecruiting
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SalvadorBrazilRecruiting
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São José do Rio PretoBrazilRecruiting
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VitóriaBrazilRecruiting
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AjaxCanadaRecruiting
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BurlingtonCanadaRecruiting
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CalgaryCanadaRecruiting
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MontrealCanadaWithdrawn
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QuébecCanadaRecruiting
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Saint-Charles-BorroméeCanadaRecruiting
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Saint-LaurentCanadaRecruiting
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SaskatoonCanadaRecruiting
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Scarborough VillageCanadaRecruiting
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TorontoCanadaWithdrawn
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Trois-RivièresCanadaRecruiting
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VancouverCanadaRecruiting
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WinchesterCanadaRecruiting
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WindsorCanadaRecruiting
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ChileChileRecruiting
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ConcepciónChileRecruiting
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CuricóChileRecruiting
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QuillotaChileRecruiting
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SantiagoChileRecruiting
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TalcaChileRecruiting
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AnyangChinaRecruiting
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BeijingChinaRecruiting
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ChangchunChinaRecruiting
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ChangshaChinaRecruiting
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ChengduChinaRecruiting
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ChongqingChinaRecruiting
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FuzhouChinaRecruiting
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GuangzhouChinaRecruiting
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HaikouChinaRecruiting
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HangzhouChinaRecruiting
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HefeiChinaRecruiting
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HengyangChinaRecruiting
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HezeChinaRecruiting
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HohhotChinaRecruiting
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HuizhouChinaRecruiting
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JinanChinaRecruiting
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JinhuaChinaRecruiting
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LinhaiChinaRecruiting
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LoudiChinaRecruiting
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NanchangChinaRecruiting
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NanchongChinaRecruiting
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NanjingChinaRecruiting
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NanningChinaRecruiting
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PingxiangChinaRecruiting
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QingdaoChinaRecruiting
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QingyuanChinaRecruiting
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SanyaChinaWithdrawn
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ShanghaiChinaWithdrawn
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ShantouChinaRecruiting
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ShenyangChinaRecruiting
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ShenzhenChinaRecruiting
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ShijiazhuangChinaRecruiting
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Suining ShiChinaRecruiting
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TaiyuanChinaRecruiting
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TaizhouChinaRecruiting
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TianjinChinaRecruiting
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WenzhouChinaRecruiting
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WuhanChinaRecruiting
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XinxiangChinaRecruiting
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XuzhouChinaRecruiting
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YangzhouChinaRecruiting
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YichangChinaRecruiting
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YinchuanChinaRecruiting
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ZhangzhouChinaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
MEDITRIAL s.r.o.
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Jindrichuv Hradec IIICzechiaActive, not recruiting
CEFISPIRO s.r.o.
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LovosiceCzechiaActive, not recruiting
Fakultni Nemocnice Plzen
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Plzen 3CzechiaActive, not recruiting
Ordinace chorob plicních s.r.o.
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PragueCzechiaActive, not recruiting
Plicni centrum s.r.o.
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PragueCzechiaActive, not recruiting
Plicni Stredisko Teplice S.R.O
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TepliceCzechiaActive, not recruiting
PNEUMOLOGIE VARNSDORF s.r.o.
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VarnsdorfCzechiaActive, not recruiting
KPPK GmbH
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BendorfGermanyRecruiting
Velocity Clinical Research Germany GmbH
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BerlinGermanyRecruiting
Pneumologicum im Suedstadtforum Dr. Alexander Schulz Dr. Martin Hoffmann Dr. Henning Geldmacher PD Dr. Hendrik Suhling Fachaerzte fuer Innere Medizin Pneumologie Partnerschaftsgesellschaft
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HanoverGermanyRecruiting
Lungenfachklinik Immenhausen
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ImmenhausenGermanyRecruiting
Zentrum fuer ambulante pneumologische Forschung Marburg GbR
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MarburgGermanyRecruiting
RoMed Klinikum Rosenheim
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RosenheimGermanyRecruiting
Lungenfacharztzentrum an den Quellen
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WiesbadenGermanyRecruiting
Region Hovedstaden
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Copenhagen NvDenmarkRecruiting
Hospital Universitario de Cruces
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BarakaldoSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
University Hospital Son Espases
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PalmaSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
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BradfordUnited KingdomRecruiting
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BrightonUnited KingdomRecruiting
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CottinghamUnited KingdomRecruiting
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GlasgowUnited KingdomRecruiting
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HalifaxUnited KingdomRecruiting
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LeedsUnited KingdomRecruiting
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PortsmouthUnited KingdomRecruiting
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Tyne and WearUnited KingdomRecruiting
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WakefieldUnited KingdomRecruiting
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AhmedabadIndiaWithdrawn
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AligarhIndiaNot yet recruiting
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BelagaviIndiaRecruiting
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CoimbatoreIndiaRecruiting
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DehradunIndiaRecruiting
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DelhiIndiaRecruiting
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DwārkaIndiaRecruiting
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FaridabadIndiaWithdrawn
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GūrgaonIndiaRecruiting
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KochiIndiaSuspended
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KolkataIndiaSuspended
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KozhikodeIndiaRecruiting
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LucknowIndiaTerminated
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MaduraiIndiaWithdrawn
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MysuruIndiaRecruiting
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NagpurIndiaRecruiting
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PuneIndiaWithdrawn
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TelanganaIndiaWithdrawn
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VadodaraIndiaRecruiting
University Hospital Of Ferrara
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FerraraItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyActive, not recruiting
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
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MontebellunaItalyActive, not recruiting
Azienda Ospedaliera dei Colli
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NaplesItalyActive, not recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyActive, not recruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyActive, not recruiting
Azienda Ospedaliero-Universitaria di Sassari
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SassariItalyActive, not recruiting
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 TermeItalyActive, not recruiting
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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TradateItalyActive, not recruiting
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Anyang-siSouth KoreaRecruiting
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DaeguSouth KoreaRecruiting
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Iksan-siSouth KoreaRecruiting
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JeonjuSouth KoreaWithdrawn
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SeoulSouth KoreaRecruiting
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Uijeongbu-siSouth KoreaRecruiting
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WŏnjuSouth KoreaRecruiting
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Benito JuárezMexicoRecruiting
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Chihuahua CityMexicoWithdrawn
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CuauhtémocMexicoWithdrawn
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CuernavacaMexicoRecruiting
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GuadalajaraMexicoNot yet recruiting
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MéridaMexicoRecruiting
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MonterreyMexicoNot yet recruiting
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MoreliaMexicoRecruiting
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Oaxaca CityMexicoRecruiting
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San Juan del RíoMexicoRecruiting
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TijunaMexicoWithdrawn
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VeracruzMexicoRecruiting
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ZapopanMexicoNot yet recruiting
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Alor StarMalaysiaRecruiting
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KajangMalaysiaRecruiting
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Kota KinabaluMalaysiaRecruiting
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Kuala LumpurMalaysiaRecruiting
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Kuala TerengganuMalaysiaRecruiting
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KuantanMalaysiaRecruiting
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KuchingMalaysiaRecruiting
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Iloilo CityPhilippinesRecruiting
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Las PiñasPhilippinesRecruiting
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Manadaluyong CityPhilippinesRecruiting
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ManilaPhilippinesRecruiting
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MarilaoPhilippinesRecruiting
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Quezon CityPhilippinesRecruiting
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TondoPhilippinesRecruiting
Centrum Medycyny Oddechowej Mroz sp. j.
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BialystokPolandRecruiting
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
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BydgoszczPolandRecruiting
Pratia S.A.
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BydgoszczPolandRecruiting
Szpital Powiatowy W Chrzanowie
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ChrzanowPolandRecruiting
Promed P.Lach R.Glowacki Sp. j.
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CracowPolandRecruiting
Endo-Med Sp. z o.o.
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KarczewPolandRecruiting
Pro Familia Altera Sp. z o.o.
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KatowicePolandRecruiting
B&R Clinical Sp. z o.o.
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KielcePolandRecruiting
Clinical Best Solutions Sp. z o.o. S.K.
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LublinPolandRecruiting
Zbigniew Żęgota Specjalistyczny Ośrodek Leczniczo Badawczy
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OstródaPolandRecruiting
Centrum Innowacyjnych Terapii Sp. z o.o.
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PiasecznoPolandRecruiting
Cbk Med Clinic Sp. z o.o.
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PlockPolandRecruiting
Alergologia Plus sp. z o.o.
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PoznanPolandRecruiting
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak
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PruszkowPolandRecruiting
Inspiro s.r.o.
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HumenneSlovakiaActive, not recruiting
Meditrez s.r.o.
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KosiceSlovakiaActive, not recruiting
Zapa Jj s.r.o.
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LeviceSlovakiaActive, not recruiting
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AlbuquerqueUnited StatesNot yet recruiting
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AtlantaUnited StatesRecruiting
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BaltimoreUnited StatesRecruiting
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BuffaloUnited StatesWithdrawn
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ChicagoUnited StatesWithdrawn
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ClearfieldUnited StatesRecruiting
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ClearwaterUnited StatesRecruiting
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ColumbiaUnited StatesRecruiting
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ColumbusUnited StatesRecruiting
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CortlandUnited StatesRecruiting
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CudahyUnited StatesRecruiting
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Cutler BayUnited StatesRecruiting
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DallasUnited StatesRecruiting
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DeBaryUnited StatesRecruiting
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DuBoisUnited StatesRecruiting
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Farmington HillsUnited StatesRecruiting
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FoleyUnited StatesRecruiting
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ForneyUnited StatesNot yet recruiting
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Fort WorthUnited StatesRecruiting
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FranklinUnited StatesRecruiting
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GainesvilleUnited StatesNot yet recruiting
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Garden GroveUnited StatesRecruiting
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High PointUnited StatesRecruiting
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HomesteadUnited StatesRecruiting
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HorseheadsUnited StatesRecruiting
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HoustonUnited StatesRecruiting
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HumbleUnited StatesRecruiting
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Johnson CityUnited StatesRecruiting
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KerrvilleUnited StatesRecruiting
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Kings MountainUnited StatesRecruiting
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Las VegasUnited StatesRecruiting
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LithoniaUnited StatesRecruiting
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MansfieldUnited StatesRecruiting
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MassapequaUnited StatesNot yet recruiting
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MeridianUnited StatesNot yet recruiting
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MiamiUnited StatesRecruiting
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MillvilleUnited StatesRecruiting
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MilwaukeeUnited StatesNot yet recruiting
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MissoulaUnited StatesRecruiting
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MobileUnited StatesRecruiting
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MorgantownUnited StatesRecruiting
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MunsterUnited StatesRecruiting
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New BernUnited StatesRecruiting
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Newport BeachUnited StatesRecruiting
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North DartmouthUnited StatesRecruiting
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Oklahoma CityUnited StatesRecruiting
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OrlandoUnited StatesRecruiting
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Palos HillsUnited StatesRecruiting
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PapillionUnited StatesRecruiting
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PhiladelphiaUnited StatesRecruiting
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PhoenixUnited StatesNot yet recruiting
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RinconUnited StatesRecruiting
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Rock HillUnited StatesRecruiting
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Saint CloudUnited StatesRecruiting
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SewellUnited StatesRecruiting
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SheffieldUnited StatesRecruiting
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St LouisUnited StatesNot yet recruiting
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TampaUnited StatesRecruiting
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The BronxUnited StatesNot yet recruiting
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Toms RiverUnited StatesRecruiting
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TorranceUnited StatesRecruiting
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TucsonUnited StatesWithdrawn
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WilmingtonUnited StatesCompleted
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WinfieldUnited StatesRecruiting
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Winston-SalemUnited StatesRecruiting

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