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NCT05742802CompletedPhase 3

Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).

A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1713 (actual)
First submitted
17 Jan 2023
Start date
6 Mar 2023
Primary completion date
26 Feb 2026
Lead sponsor
AstraZeneca
Diseases
COPD
NCT number
NCT05742802
EU CT number
2022-501063-41-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1713
  • From 6 Mar 2023 to the primary completion date, 26 Feb 2026
  • 325 sites in 37 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

  • Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
  • Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.

Other illness

  • Known history of:
    • Severe allergic reaction to any monoclonal and polyclonal antibody.
    • Allergy or reaction to any component of the IP formulation.

Lab values

  • Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.

Other

  • Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
  • Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).
  • Participants who are not able to comply with the study requirements, procedures, and restrictions.

Who the study is looking for

  • Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
  • Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
  • FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
  • Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
  • Capable of giving signed informed consent.

Age in the registry: 40 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (325)

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

SiteCityCountrySite status
Research Site
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Buenos AiresArgentinaUnknown status
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CABAArgentinaUnknown status
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Ciudad de Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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Mar del PlataArgentinaUnknown status
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MendozaArgentinaUnknown status
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QuilmesArgentinaUnknown status
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San FernandoArgentinaUnknown status
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San Juan BautistaArgentinaUnknown status
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San Miguel de TucumánArgentinaUnknown status
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CampbelltownAustraliaUnknown status
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FrankstownAustraliaUnknown status
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Macquarie UniversityAustraliaUnknown status
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MelbourneAustraliaUnknown status
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NedlandsAustraliaUnknown status
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SouthportAustraliaUnknown status
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SpearwoodAustraliaUnknown status
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WollongongAustraliaUnknown status
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Woodville SouthAustraliaUnknown status
CHU Saint-Pierre
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BrusselsBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumCompleted
Pneumocare
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NamurBelgiumCompleted
Многопрофилна Болница За Активно Лечение Свети Иван Рилски 2003 ООД
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DupnitsaBulgariaCompleted
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Haskovo EOOD
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HaskovoBulgariaCompleted
Medical Center Zdrave-1 OOD
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KozloduyBulgariaCompleted
Medical Centre Leo Clinic EOOD
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LovechBulgariaCompleted
Medical Center Health Care Ltd.
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PetrichBulgariaCompleted
Multi-profile Hospital for Active Treatment Heart and Brain EAD
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PlevenBulgariaCompleted
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
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RuseBulgariaCompleted
Diagnostichno-Konsultativen Centar-Sliven OOD
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SlivenBulgariaCompleted
Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel
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SofiyaBulgariaCompleted
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
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SofiyaBulgariaCompleted
Specialized Hospital For Active Treatment Of Pulmonary Diseases Sofia Region Eood
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SofiyaBulgariaCompleted
Specialized Hospital For Active Treatment Of Pulmonary Diseases Troyan EOOD
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TroyanBulgariaCompleted
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD
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VratsaBulgariaCompleted
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BlumenauBrazilUnknown status
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BotucatuBrazilUnknown status
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BrasíliaBrazilUnknown status
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CuritibaBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Rio de JaneiroBrazilUnknown status
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São Bernardo do CampoBrazilUnknown status
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São PauloBrazilUnknown status
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AjaxCanadaUnknown status
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EdmontonCanadaUnknown status
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GuelphCanadaUnknown status
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MontrealCanadaUnknown status
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QuébecCanadaUnknown status
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Sherwood ParkCanadaUnknown status
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WinchesterCanadaUnknown status
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ChileChileUnknown status
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CuricóChileUnknown status
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SantiagoChileUnknown status
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TalcaChileUnknown status
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BaotouChinaUnknown status
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BeijingChinaUnknown status
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ChangchunChinaUnknown status
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ChangshaChinaUnknown status
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ChengduChinaUnknown status
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ChongqingChinaUnknown status
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GuangzhouChinaUnknown status
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HaikouChinaUnknown status
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HangzhouChinaUnknown status
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HohhotChinaUnknown status
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KunmingChinaUnknown status
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LinhaiChinaUnknown status
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NanchangChinaUnknown status
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NanjingChinaUnknown status
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NingboChinaUnknown status
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ShanghaiChinaUnknown status
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ShenyangChinaUnknown status
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ShenzhenChinaUnknown status
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ShijiazhuangChinaUnknown status
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SuzhouChinaUnknown status
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TaiyuanChinaUnknown status
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WuhanChinaUnknown status
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WuxiChinaUnknown status
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XiamenChinaUnknown status
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XuzhouChinaUnknown status
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YangzhouChinaUnknown status
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YinchuanChinaUnknown status
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ZhanjiangChinaUnknown status
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ZunyiChinaUnknown status
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BarranquillaColombiaUnknown status
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IbagueColombiaUnknown status
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RionegroColombiaUnknown status
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ZipaquiráColombiaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Nemocnice Jihlava prispevkova organizace
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Jihlava 1CzechiaCompleted
Krajska nemocnice Liberec a.s.
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Liberec (neclenene Mesto)CzechiaCompleted
University Hospital Olomouc
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OlomoucCzechiaCompleted
MediTrial s.r.o.
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Prague 8CzechiaCompleted
MUDr. Josef Veverka
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RokycanyCzechiaCompleted
CIMS Studienzentrum Bamberg GmbH
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BambergGermanyCompleted
Policum Berlin Studien GmbH
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BerlinGermanyCompleted
Research Center for Medical Studies (RCMS)
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BerlinGermanyCompleted
Pneumo Studien Darmstadt GmbH
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DarmstadtGermanyCompleted
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
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GroßhansdorfGermanyCompleted
Pneumologicum Halle
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HalleGermanyCompleted
Zentrum für klinische Forschung
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KölnGermanyCompleted
Zentrum Fur Ambulante Pneumologische Forschung Marburg GbR
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MarburgGermanyCompleted
Pneumologische Praxis München-Pasing
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MünchenGermanyCompleted
Studienzentrum Dr.Schlenska
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PeineGermanyCompleted
Aalborg University Hospital
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AalborgDenmarkCompleted
Bispebjerg Hospital
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Copenhagen NvDenmarkCompleted
Hvidovre Hospital
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HvidovreDenmarkCompleted
Næstved Hospital
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NæstvedDenmarkCompleted
Zealand University Hospital
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RoskildeDenmarkCompleted
Lillebaelt Hospital
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VejleDenmarkCompleted
Hospital de Galdakao-Usansolo
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GaldakaoSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Hospital de Mérida
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MéridaSpainCompleted
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Hospital Unviersitario Miguel Servet
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ZaragozaSpainCompleted
Kanta-Häme Central Hospital
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HämeenlinnaFinlandCompleted
Suomen Terveystalo Oy
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HelsinkiFinlandCompleted
Helsinki University Central Hospital
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HelsinkiFinlandCompleted
Kuopio University Hospital
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KuopioFinlandCompleted
Tampere University Hospital
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TampereFinlandCompleted
Turku University Hospital
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TurkuFinlandCompleted
Hospital De La Cavale Blanche
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BrestFranceCompleted
Centre Hospitalier Universitaire de Dijon
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DijonFranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Groupe Hospitalier Du Havre
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Le Havre CedexFranceCompleted
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceCompleted
Hopital De La Croix-Rousse
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Lyon Cedex 04FranceCompleted
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceCompleted
University Hospital Of Montpellier
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Montpellier Cedex 5FranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Hospital Foch
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SuresnesFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
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BradfordUnited KingdomUnknown status
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CorbyUnited KingdomUnknown status
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High WycombeUnited KingdomUnknown status
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NorthwoodUnited KingdomUnknown status
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PrestonUnited KingdomUnknown status
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ShipleyUnited KingdomUnknown status
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceCompleted
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceCompleted
University General Hospital of Ioannina
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IoanninaGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceCompleted
Bajai Szent Rokus Korhaz
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BajaHungaryCompleted
SYNEXUS Magyarorszag Kft.
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Budapest IIIHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Edelenyi Koch Robert Korhaz es Rendelointezet
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EdelényHungaryCompleted
CRU Hungary Kft.
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EncsHungaryCompleted
Bugat Pal Korhaz Kht.
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GyongyosHungaryCompleted
Omnimodus Elixír Kft.
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MosonmagyaróvárHungaryCompleted
Simplex Kft.
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NyiregyhazaHungaryCompleted
Allergo-Fot Kft.
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SzazhalombattaHungaryCompleted
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AshkelonIsraelUnknown status
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BeershebaIsraelUnknown status
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JerusalemIsraelUnknown status
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Kfar SabaIsraelUnknown status
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RehovotIsraelUnknown status
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Tel AvivIsraelUnknown status
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BelagaviIndiaUnknown status
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CoimbatoreIndiaUnknown status
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DehradunIndiaUnknown status
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JaipurIndiaUnknown status
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NagpurIndiaUnknown status
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NashikIndiaUnknown status
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New DelhiIndiaUnknown status
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ThaneIndiaUnknown status
University Hospital Consorziale Policlinico
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BariItalyCompleted
Nuovo Ospedale Apuane Massa
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MassaItalyCompleted
ASST Fatebenefratelli Sacco
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MilanItalyCompleted
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
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MilanItalyCompleted
Azienda Ospedaliera dei Colli
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NaplesItalyCompleted
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
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NaplesItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
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SalernoItalyCompleted
Azienda Ospedaliero-Universitaria di Sassari
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SassariItalyCompleted
Ospedale S.G. Moscati
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StatteItalyCompleted
ICS Maugeri IRCCS Telese
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Telese TermeItalyCompleted
Istituti Clinici Scientifici Maugeri
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TradateItalyCompleted
Azienda Sanitaria Locale Vercelli
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VercelliItalyCompleted
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyCompleted
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Asahikawa-shiJapanUnknown status
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Fujieda-shiJapanUnknown status
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FukuokaJapanUnknown status
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HamamatsuJapanUnknown status
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HiroshimaJapanUnknown status
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Iizuka-shiJapanUnknown status
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Iwata-shiJapanUnknown status
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KanazawaJapanUnknown status
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Kawachinagano-shiJapanUnknown status
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KobeJapanUnknown status
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Matsusaka-shiJapanUnknown status
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Mizunami-shiJapanUnknown status
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NagoyaJapanUnknown status
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ObihiroJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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Shinjuku-kuJapanUnknown status
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ShizuokaJapanUnknown status
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tabashi CityJapanUnknown status
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Toshima-kuJapanUnknown status
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Toyonaka-shiJapanUnknown status
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YokohamaJapanUnknown status
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DaeguSouth KoreaUnknown status
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IncheonSouth KoreaUnknown status
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JeonjuSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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Benito JuárezMexicoUnknown status
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Chihuahua CityMexicoUnknown status
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GuadalajaraMexicoUnknown status
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MéxicoMexicoUnknown status
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MonterreyMexicoUnknown status
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MoreliaMexicoUnknown status
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Oaxaca CityMexicoUnknown status
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VeracruzMexicoUnknown status
Catharina Ziekenhuis Stichting
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EindhovenNetherlandsCompleted
Universitair Medisch Centrum Groningen
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GroningenNetherlandsCompleted
Ziekenhuis St Jansdal
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HarderwijkNetherlandsCompleted
Stichting Zuyderland Medisch Centrum
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HeerlenNetherlandsCompleted
Gelre Hospitals
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ZutphenNetherlandsCompleted
Stichting Isala Klinieken
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ZwolleNetherlandsCompleted
Helse Bergen HF
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BergenNorwayCompleted
Nordlandssykehuset HF
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BodoNorwayCompleted
Akershus University Hospital
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LørenskogNorwayCompleted
Oslo University Hospital HF
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OsloNorwayCompleted
Vestfold Hospital Trust
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TonsbergNorwayCompleted
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LimaPeruUnknown status
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Baguio CityPhilippinesUnknown status
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Cebu CityPhilippinesUnknown status
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Iloilo CityPhilippinesUnknown status
Centrum Medycyny Oddechowej Mroz sp. j.
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BialystokPolandCompleted
Centrum Medyczne Pratia Bydgoszcz
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BydgoszczPolandCompleted
Centrum Medyczne All-Med Badania Kliniczne
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CracowPolandCompleted
Pro Familia Altera Sp. z o.o.
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KatowicePolandCompleted
Pro Life Medica Sp. z o.o.
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LublinPolandCompleted
Zbigniew Żęgota Specjalistyczny Ośrodek Leczniczo Badawczy
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OstródaPolandCompleted
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
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Ostrowiec ŚwiętokrzyskiPolandCompleted
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
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PoznanPolandCompleted
Specjalistyczny Niepubliczny Zakład Opieki Zdrowotnej Alergologia Plus
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PoznanPolandCompleted
EMED Centrum Uslug Medycznych Ewa Smialek
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RzeszówPolandCompleted
PULMAG Grzegorz Gasior Marzena Kociolek sc
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SosnowiecPolandCompleted
Lekarze Specjalisci - J. Malolepszy I Partnerzy
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WroclawPolandCompleted
Michal Bogacki Dobrostan
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WroclawPolandCompleted
Hospital Da Luz Guimaraees S.A.
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GuimaraesPortugalCompleted
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalCompleted
Hospital Cuf Descobertas S.A.
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LisbonPortugalCompleted
Unidade Local De Saude De Matosinhos E.P.E.
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Senhora Da HoraPortugalCompleted
Hospital De Vila Franca De Xira E.P.E.
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Vila Franca De XiraPortugalCompleted
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalCompleted
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
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BrasovRomaniaCompleted
Institutul de pneumoftiziologie Marius Nasta
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BucharestRomaniaCompleted
Spitalul Clinic de Pneumoftiziologie Leon Daniello
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Cluj-NapocaRomaniaCompleted
Spitalul Clinic De Pneumoftiziologie Constanta
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Palazu MareRomaniaCompleted
Fundatia Cardioprevent
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TimișoaraRomaniaCompleted
Sahlgrenska University Hospital-Vastra Gotalandsregionen
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GothenburgSwedenCompleted
ProbarE i Lund AB
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LundSwedenCompleted
Lunds Universitet
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MalmoSwedenCompleted
Halsoklustret AB
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This page is information, not medical advice. Discuss any trial with your doctor.