Clinical trial • Phase III • Respiratory

N/A for Eosinophilic asthma

Phase III trial of N/A for Eosinophilic asthma.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Eosinophilic asthma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
07-11-2024
First CTIS Authorization Date
17-03-2025

Trial design

Randomised, placebo for benralizumab (matching placebo); escalation therapy with high-dose ics-laba (symbicort forte turbuhaler 320 microgramos/9 microgramos inhalation as the high-dose ics-laba comparator).-controlled Phase III trial in Ireland, Italy, Norway and others.

Randomised
Yes
Comparator
Placebo for Benralizumab (matching placebo); escalation therapy with high-dose ICS-LABA (Symbicort forte Turbuhaler 320 microgramos/9 microgramos inhalation as the high-dose ICS-LABA comparator).
Target Sample Size
228
Trial Duration For Participant
336

Eligibility

Recruits 228 No vulnerable populations selected; participants are adults aged 18–75 and must provide written informed consent. No assent procedures for minors are applicable..

Vulnerable Population
No vulnerable populations selected; participants are adults aged 18–75 and must provide written informed consent. No assent procedures for minors are applicable.

Inclusion criteria

  • {"criterion_text":"- Written informed consent"}
  • {"criterion_text":"- Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol"}
  • {"criterion_text":"- At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary."}
  • {"criterion_text":"- Participant must be 18 to 75 years of age"}
  • {"criterion_text":"- Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1."}
  • {"criterion_text":"- Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids)."}
  • {"criterion_text":"- Weight of ≥ 35 kg."}
  • {"criterion_text":"- Pre-BD FEV1 of ≤ 90% predicted"}
  • {"criterion_text":"- Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent"}
  • {"criterion_text":"- ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3"}
  • {"criterion_text":"- Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol"}

Exclusion criteria

  • {"criterion_text":"- Important pulmonary disease other than asthma at the discretion of the investigator (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome)."}
  • {"criterion_text":"- Asthma exacerbation requiring use of SCS, or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period"}
  • {"criterion_text":"- Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol"}
  • {"criterion_text":"- Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator’s discretion"}
  • {"criterion_text":"- Concurrent participation in another clinical study with an IP or a post-authorisation safety study."}
  • {"criterion_text":"- Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible."}
  • {"criterion_text":"- History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Endpoint: AAER during the 48-week treatment period.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in SGRQ total score to EOT (Week 48)","definition_or_measurement_approach":"Change from baseline measured by St. George's Respiratory Questionnaire (SGRQ) total score at end of treatment (Week 48)."}

Recruitment

Registry Or Advocacy Recruitment
True, Center For Information And Study On Clinical Research Participation Inc.
Digital Remote Recruitment
True — digital methods include social media banners and other online recruitment materials (social media assets and digital banners listed in recruitment documents).
Planned Sample Size
228
Recruitment Window Months
30
Consent Approach
Written informed consent is required from participants (adults aged 18–75). Subject information sheets and informed consent forms are available in multiple languages (documents include English, Bulgarian, French, German, Italian, Spanish, Norwegian versions). Assent is not applicable.

Methods

  • Site advert toolkit (documents titled 'Site advert toolkit' available for sites to use for local recruitment).
  • Social media banners (documents titled 'Social Media Banners' for digital recruitment channels / social media).
  • Patient information brochure / brochure (K2_Patient Information Brochure and equivalents in multiple languages for potential participants).
  • Study consent aid (study consent aids to support participant understanding and recruitment).
  • Recruitment arrangements documents (K1_Recruitment Arrangements / K1_Recruitment and ICF procedure) provided to sites.

Geography

Total Number Of Sites
75
Total Number Of Participants
152

Ireland

Earliest CTIS Part Ii Submission Date
21-02-2025
Latest Decision Or Authorization Date
21-05-2025
Processing Time Days
89
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Cork University Hospital
Department Name
Respiratory Medicine
Principal Investigator Name
Des Murphy
Principal Investigator Email
Desmond.murphy@hse.ie
Contact Person Name
Des Murphy
Contact Person Email
Desmond.murphy@hse.ie
Site Name
Our Lady Of Lourdes Hospital
Department Name
Respiratory
Principal Investigator Name
Tidi Hassan
Principal Investigator Email
Desmond.murphy@hse.ie
Contact Person Name
Tidi Hassan
Contact Person Email
Desmond.murphy@hse.ie
Site Name
Portiuncula University Hospital
Department Name
Respiratory
Principal Investigator Name
Hilary McLoughlin
Principal Investigator Email
Hilary.mcloughlin@hse.ie
Contact Person Name
Hilary McLoughlin
Contact Person Email
Hilary.mcloughlin@hse.ie
Site Name
Connolly Hospital
Department Name
Respiratory
Principal Investigator Name
Abirami Subramaniam
Principal Investigator Email
abiramisubramaniam@crp.healthcare
Contact Person Name
Abirami Subramaniam

Italy

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
249
Number Of Sites
14
Number Of Participants
35

Sites

Site Name
Azienda Ospedaliera Dei Colli
Department Name
UOSD Respiratory Diseases
Principal Investigator Name
Anna Agnese Stanziola
Principal Investigator Email
annaagnese.stanziola@unina.it
Contact Person Name
Anna Agnese Stanziola
Contact Person Email
annaagnese.stanziola@unina.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Fisiopatology respiratory
Principal Investigator Name
Laura Pini
Principal Investigator Email
laura.pini@unibs.it
Contact Person Name
Laura Pini
Contact Person Email
laura.pini@unibs.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
UOC Pneumology
Principal Investigator Name
Fabiano Di Marco
Principal Investigator Email
fdimarco@asst-pg23.it
Contact Person Name
Fabiano Di Marco
Contact Person Email
fdimarco@asst-pg23.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Allergology
Principal Investigator Name
Cristiano Caruso
Principal Investigator Email
cristiano.caruso@policlinicogemelli.it
Contact Person Name
Cristiano Caruso
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Pneumology
Principal Investigator Name
Francesco Menzella
Principal Investigator Email
francesco.menzella@aulss2.veneto.it
Contact Person Name
Francesco Menzella
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinic of Respiratory Diseases and Allergology
Principal Investigator Name
Fulvio Braido
Principal Investigator Email
fulvio.braido@unige.it
Contact Person Name
Fulvio Braido
Contact Person Email
fulvio.braido@unige.it
Site Name
University Hospital Consorziale Policlinico
Department Name
"University Respiratory System Diseases"
Principal Investigator Name
Giovanna Elisiana Carpagnano
Principal Investigator Email
elisiana.carpagnano@uniba.it
Contact Person Name
Giovanna Elisiana Carpagnano
Contact Person Email
elisiana.carpagnano@uniba.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Operational Unit of Pneumology I
Principal Investigator Name
Stefano Aliberti
Principal Investigator Email
stefano.aliberti@hunimed.eu
Contact Person Name
Stefano Aliberti
Contact Person Email
stefano.aliberti@hunimed.eu
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Centro Ricerche Cliniche Di Verona S.r.l.
Principal Investigator Name
Marco Caminati
Principal Investigator Email
marco.caminati@univr.it
Contact Person Name
Marco Caminati
Contact Person Email
marco.caminati@univr.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Respiratory System Diseases
Principal Investigator Name
Bianca Beghè
Principal Investigator Email
bianca.beghe@unimore.it
Contact Person Name
Bianca Beghè
Contact Person Email
bianca.beghe@unimore.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Department of Medical area – Unit of Pneumology and Cystic Fibrosis
Principal Investigator Name
Mirta Cavallini
Principal Investigator Email
mirta.cavallini@policlinico.mi.it
Contact Person Name
Mirta Cavallini
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
Allergologia e immunologia clinica
Principal Investigator Name
Stefano Del Giacco
Principal Investigator Email
delgiac@gmail.com
Contact Person Name
Stefano Del Giacco
Contact Person Email
delgiac@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UO Pneumologia
Principal Investigator Name
Matteo Bonini
Principal Investigator Email
matteo.bonini@uniroma1.it
Contact Person Name
Matteo Bonini
Contact Person Email
matteo.bonini@uniroma1.it
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
UO Pneumologia
Principal Investigator Name
Girolamo Pelaia
Principal Investigator Email
pelaia@unicz.it
Contact Person Name
Girolamo Pelaia
Contact Person Email
pelaia@unicz.it

Norway

Earliest CTIS Part Ii Submission Date
13-03-2025
Latest Decision Or Authorization Date
03-07-2025
Processing Time Days
112
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Akershus University Hospital
Department Name
Pulmonary Department
Principal Investigator Name
Gunnar Einvik
Principal Investigator Email
Gunnar.Einvik@ahus.no
Contact Person Name
Gunnar Einvik
Contact Person Email
Gunnar.Einvik@ahus.no

France

Earliest CTIS Part Ii Submission Date
19-02-2025
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
300
Number Of Sites
9
Number Of Participants
30

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Pneumology
Principal Investigator Name
Arnaud BOURDIN
Principal Investigator Email
a-bourding@chu-montpellier.fr
Contact Person Name
Arnaud BOURDIN
Contact Person Email
a-bourding@chu-montpellier.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Pneumology
Principal Investigator Name
Cécilia NOCENT
Principal Investigator Email
cnocent@ch-cotebasque.fr
Contact Person Name
Cécilia NOCENT
Contact Person Email
cnocent@ch-cotebasque.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pneumology
Principal Investigator Name
Christel SAINT RAYMOND
Principal Investigator Email
csaint-raymond@chu-grenoble.fr
Contact Person Name
Christel SAINT RAYMOND
Contact Person Email
csaint-raymond@chu-grenoble.fr
Site Name
Reseau De Sante Mutualiste
Department Name
Pneumology
Principal Investigator Name
Jean-Marc DOT
Principal Investigator Email
j.dot@resamut.fr
Contact Person Name
Jean-Marc DOT
Contact Person Email
j.dot@resamut.fr
Site Name
Hospital Foch
Department Name
Pneumology
Principal Investigator Name
Colas TCHERAKIAN
Principal Investigator Email
c.tcherakian@hopital-foch.com
Contact Person Name
Colas TCHERAKIAN
Contact Person Email
c.tcherakian@hopital-foch.com
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Pneumology
Principal Investigator Name
Amel BOUDJEMAA
Principal Investigator Email
amel.boudjemaa@chicreteil.fr
Contact Person Name
Amel BOUDJEMAA
Contact Person Email
amel.boudjemaa@chicreteil.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Pneumology
Principal Investigator Name
Patrick BERGER
Principal Investigator Email
patrick.berger@chu-bordeaux.fr
Contact Person Name
Patrick BERGER
Contact Person Email
patrick.berger@chu-bordeaux.fr
Site Name
Hopital De La Croix-Rousse
Department Name
Pneumology
Principal Investigator Name
Gilles DEVOUASSOUX
Principal Investigator Email
gilles.devouassoux@chu-lyon.fr
Contact Person Name
Gilles DEVOUASSOUX
Contact Person Email
gilles.devouassoux@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pneumology-Allergology
Principal Investigator Name
Laurent GUILLEMINAULT
Principal Investigator Email
guilleminault.l@chu-toulouse.fr
Contact Person Name
Laurent GUILLEMINAULT

Germany

Earliest CTIS Part Ii Submission Date
05-03-2025
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
386
Number Of Sites
16
Number Of Participants
31

Sites

Site Name
Lungenfacharztzentrum Wiesbaden BAG
Principal Investigator Name
Peter Fried
Principal Investigator Email
Peter-Fried@web.de
Contact Person Name
Peter Fried
Contact Person Email
Peter-Fried@web.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik V
Principal Investigator Name
Alexandra Lenoir
Principal Investigator Email
Alexandra.Lenoir@med.uni-muenchen.de
Contact Person Name
Alexandra Lenoir
Site Name
Velocity Clinical Research Germany GmbH
Principal Investigator Name
Nakul Modi
Principal Investigator Email
Nmodi@velocityclinical.com
Contact Person Name
Nakul Modi
Contact Person Email
Nmodi@velocityclinical.com
Site Name
Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH
Principal Investigator Name
Sabine Ballenberger
Principal Investigator Email
ballenberger@bfw-institut.de
Contact Person Name
Sabine Ballenberger
Contact Person Email
ballenberger@bfw-institut.de
Site Name
MECS Medical and Clinical Studies Cottbus GmbH
Principal Investigator Name
Frank Kaessner
Principal Investigator Email
f.kaessner@mecs24.de
Contact Person Name
Frank Kaessner
Contact Person Email
f.kaessner@mecs24.de
Site Name
Pneumologisches Forschungsinstitut Hohegeest GbR
Principal Investigator Name
Wolfgang Zachgo
Principal Investigator Email
wz@mikloweit-zachgo.de
Contact Person Name
Wolfgang Zachgo
Contact Person Email
wz@mikloweit-zachgo.de
Site Name
Kliniken Maria Hilf GmbH Moenchengladbach
Department Name
Department of Pneumology
Principal Investigator Name
Fabian Hoffmann
Principal Investigator Email
Fabian.hoffmann@mariahilf.de
Contact Person Name
Fabian Hoffmann
Contact Person Email
Fabian.hoffmann@mariahilf.de
Site Name
Lungenfachzentrum Rhein-Main
Principal Investigator Name
Torsten Born
Principal Investigator Email
born@lungenfachzentrum-rheinmain.de
Contact Person Name
Torsten Born
Site Name
Studienzentrum Dr. Keller
Principal Investigator Name
Claus Keller
Principal Investigator Email
ckeller-studien@oraxis-ckeller.de
Contact Person Name
Claus Keller
Site Name
Asklepios MVZ Bayern GmbH
Department Name
Pneumologie
Principal Investigator Name
Florian Fliedner
Principal Investigator Email
f.fliedner@mvz-ll.de
Contact Person Name
Florian Fliedner
Contact Person Email
f.fliedner@mvz-ll.de
Site Name
Lungenpraxis Zossen
Principal Investigator Name
Christoph Ruwwe-Gloesenkamp
Principal Investigator Email
info@lungenpraxis-zossen.de
Contact Person Name
Christoph Ruwwe-Gloesenkamp
Contact Person Email
info@lungenpraxis-zossen.de
Site Name
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Department Name
Department of Pneumology
Principal Investigator Name
Kaid Darwiche
Principal Investigator Email
Kaid.Darwiche@lkhemer.de
Contact Person Name
Kaid Darwiche
Contact Person Email
Kaid.Darwiche@lkhemer.de
Site Name
Lungenpraxis Hohenzollerndamm Research Center for Medical Studies
Principal Investigator Name
Bjoern Martens
Contact Person Name
Bjoern Martens
Site Name
Lungenpraxis Witten - Gemeinschaftspraxis Drs. Franz und Weber
Principal Investigator Name
Karl-Heinz Franz
Principal Investigator Email
franz@lungenfacharzt.de
Contact Person Name
Karl-Heinz Franz
Contact Person Email
franz@lungenfacharzt.de
Site Name
Gemeinschaftspraxis für Kardiologie/Pneumologie Dr.med. Andreas Foerster/Dr.med. Karin Foerster
Principal Investigator Name
Karina Foerster
Principal Investigator Email
drfoersterk@arcor.de
Contact Person Name
Karina Foerster
Contact Person Email
drfoersterk@arcor.de
Site Name
Allergie - und Asthma Studienzentrum
Principal Investigator Name
Tomasz Ginko
Principal Investigator Email
tginko@gmail.com
Contact Person Name
Tomasz Ginko
Contact Person Email
tginko@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
19-02-2025
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
428
Number Of Sites
11
Number Of Participants
10

Sites

Site Name
Alexandrovska University Hospital
Department Name
Clinic of clinical allergology
Principal Investigator Name
Maria Staevska–Kotasheva
Principal Investigator Email
dr.mariya.staevska@gmail.com
Contact Person Name
Maria Staevska–Kotasheva
Contact Person Email
dr.mariya.staevska@gmail.com
Site Name
UNIMED Medical Center EOOD
Principal Investigator Name
Mariya Dimitrova - Georgieva
Principal Investigator Email
drmariadimitrova@gmail.com
Contact Person Name
Mariya Dimitrova - Georgieva
Contact Person Email
drmariadimitrova@gmail.com
Site Name
MC Re Spiro OOD
Principal Investigator Name
Ivan Kiselov
Principal Investigator Email
respiroltd@abv.bg
Contact Person Name
Ivan Kiselov
Contact Person Email
respiroltd@abv.bg
Site Name
Multiprofile Hospital For Active Treatment Sveta Ekaterina-Dimitrovgrad EOOD
Department Name
Department of internal diseases
Principal Investigator Name
Todor Atanasov
Principal Investigator Email
todor.atanasow@gmail.com
Contact Person Name
Todor Atanasov
Contact Person Email
todor.atanasow@gmail.com
Site Name
Medical Center FAMA Medical Ltd.
Principal Investigator Name
Blagoy Marinov
Principal Investigator Email
bmarinoff@gmail.com
Contact Person Name
Blagoy Marinov
Contact Person Email
bmarinoff@gmail.com
Site Name
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
Department Name
Department of Pulmonology
Principal Investigator Name
Yordanka Krasteva Dacheva
Principal Investigator Email
canda_dacheva@yahoo.com
Contact Person Name
Yordanka Krasteva Dacheva
Contact Person Email
canda_dacheva@yahoo.com
Site Name
Prevencia 2000 MCDMP
Principal Investigator Name
Vanya Ilieva-Fartunova
Principal Investigator Email
ilvan@abv.bg
Contact Person Name
Vanya Ilieva-Fartunova
Contact Person Email
ilvan@abv.bg
Site Name
Medical Center Pulmo-2018
Principal Investigator Name
Veselin Kalfov
Principal Investigator Email
kalfov@abv.bg
Contact Person Name
Veselin Kalfov
Contact Person Email
kalfov@abv.bg
Site Name
Medical Center New Rehabilitation Center EOOD
Principal Investigator Name
Dimo Dimov
Principal Investigator Email
dmdimov65@yahoo.com
Contact Person Name
Dimo Dimov
Contact Person Email
dmdimov65@yahoo.com
Site Name
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD
Department Name
Clinic of Internal Diseases
Principal Investigator Name
Dinko Valev
Principal Investigator Email
dinko.g.valev@abv.bg
Contact Person Name
Dinko Valev
Contact Person Email
dinko.g.valev@abv.bg
Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
First Department of Pulmonology and Phthisiology
Principal Investigator Name
Iliya Krachunov
Principal Investigator Email
i.krachunov.pn@heartandbrain.bg
Contact Person Name
Iliya Krachunov

Spain

Earliest CTIS Part Ii Submission Date
20-02-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
433
Number Of Sites
20
Number Of Participants
50

Sites

Site Name
Hospital San Pedro De Alcantara
Department Name
Pneumology
Principal Investigator Name
Manuel Sojo Gonzalez
Principal Investigator Email
asojogon@gmail.com
Contact Person Name
Manuel Sojo Gonzalez
Contact Person Email
asojogon@gmail.com
Site Name
Hospital Universitario De Burgos
Department Name
Pneumology
Principal Investigator Name
Maria Victoria Garcia Gallardo Sanz
Principal Investigator Email
victoriagarciagallardo@yahoo.es
Contact Person Name
Maria Victoria Garcia Gallardo Sanz
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Pneumology
Principal Investigator Name
Jose Velasco Garrido
Principal Investigator Email
josel.velasco.sspa@juntadeandalucia.es
Contact Person Name
" Jose " Velasco Garrido
Site Name
Hospital Quironsalud Marbella
Department Name
Pneumology
Principal Investigator Name
Jose-Maria Ignacio-Garcia
Principal Investigator Email
josemariaignacio@gmail.com
Contact Person Name
Jose-Maria Ignacio-Garcia
Contact Person Email
josemariaignacio@gmail.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Pneumology
Principal Investigator Name
Walther Iván Girón Matute
Principal Investigator Email
walter_giron2@hotmail.com
Contact Person Name
Walther Iván Girón Matute
Contact Person Email
walter_giron2@hotmail.com
Site Name
Hospital Universitario De La Ribera
Department Name
Pneumology
Principal Investigator Name
Inmaculada Lluch Tortajada
Principal Investigator Email
inlluch1980@hotmail.com
Contact Person Name
Inmaculada Lluch Tortajada
Contact Person Email
inlluch1980@hotmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Pneumology
Principal Investigator Name
Silvia Sanchez Cuellar
Principal Investigator Email
sscuellar@salud.madrid.org
Contact Person Name
Silvia Sanchez Cuellar
Contact Person Email
sscuellar@salud.madrid.org
Site Name
Hospital Universitario Lucus Augusti
Department Name
Pneumology
Principal Investigator Name
Luis Alejandro Perez de Llano
Principal Investigator Email
eremos26@hotmail.com
Contact Person Name
Luis Alejandro Perez de Llano
Contact Person Email
eremos26@hotmail.com
Site Name
University Hospital Son Espases
Department Name
Pneumology
Principal Investigator Name
Francisco de Borja Garcia-Cosio Piqueras
Principal Investigator Email
borja.cosio@ssib.es
Contact Person Name
Francisco de Borja Garcia-Cosio Piqueras
Contact Person Email
borja.cosio@ssib.es
Site Name
Hospital Costa Del Sol
Department Name
Pneumology
Principal Investigator Name
Maria Perez Morales
Principal Investigator Email
mariaperezmorales7@gmail.com
Contact Person Name
Maria Perez Morales
Contact Person Email
mariaperezmorales7@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Pneumology
Principal Investigator Name
Ismael Garcia Moguel
Principal Investigator Email
igmoguel@salud.madrid.org
Contact Person Name
Ismael Garcia Moguel
Contact Person Email
igmoguel@salud.madrid.org
Site Name
Hospital De Jerez De La Frontera
Department Name
Pneumology
Principal Investigator Name
Jose Gregorio Soto Campos
Principal Investigator Email
josesoto@neumosur.net
Contact Person Name
Jose Gregorio Soto Campos
Contact Person Email
josesoto@neumosur.net
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Pneumology
Principal Investigator Name
Concepción Morales García
Contact Person Name
Concepción Morales García
Site Name
Hospital Universitari Vall D Hebron
Department Name
Pneumology
Principal Investigator Name
Xavier Muñoz
Principal Investigator Email
xavier.munoz@vallhebron.cat
Contact Person Name
Xavier Muñoz
Contact Person Email
xavier.munoz@vallhebron.cat
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Pneumology
Principal Investigator Name
Ana Rosado
Principal Investigator Email
ana.rosado@salud.madrid.org
Contact Person Name
Ana Rosado
Contact Person Email
ana.rosado@salud.madrid.org
Site Name
Hospital San Eloy
Department Name
Pneumology
Principal Investigator Name
Jesus Camino Buey
Principal Investigator Email
jesus.caminobuey@osakidetza.eus
Contact Person Name
Jesus Camino Buey
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Pneumology
Principal Investigator Name
David Ramos Barbon
Principal Investigator Email
DRamosB@santpau.cat
Contact Person Name
David Ramos Barbon
Contact Person Email
DRamosB@santpau.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Pneumology
Principal Investigator Name
Juan Luis Garcia Rivero
Principal Investigator Email
juanluis.garcia@scsalud.es
Contact Person Name
Juan Luis Garcia Rivero
Contact Person Email
juanluis.garcia@scsalud.es
Site Name
Hospital Germans Trias I Pujol
Department Name
Pneumology
Principal Investigator Name
Carlos Martinez Rivera
Principal Investigator Email
carlosmartinezrivera.cmr@gmail.com
Contact Person Name
Carlos Martinez Rivera
Site Name
Hospital De Merida
Department Name
Pneumology
Principal Investigator Name
Antonio Manuel Perez Fernandez
Principal Investigator Email
antonio.perezf@salud-juntaex.es
Contact Person Name
Antonio Manuel Perez Fernandez

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Almac Clinical Services (Ireland) Limited
Responsibilities
Drug destruction
Name
Longboat Clinical Limited
Responsibilities
Patient recruitment/retention
Name
Q Squared Solutions Limited
Name
Medidata Solutions Inc.
Name
Fortrea Inc.
Responsibilities
Management of submission to EC/RA

Third parties

  • {"country":"United States","full_name":"Scarritt Group Inc.","duties_or_roles":"patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"Drug destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Patient recruitment/retention","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"CTT-PE","organisation_type":"Patient organisation/association"}
  • {"country":"United States","full_name":"Perceptive Informatics, LLC","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"AAC","duties_or_roles":"Provide medical coverage 24/7 for sites","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Management of submission to EC/RA","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Placebo for Benralizumab
Modality
Other
Investigational Product Name
Fasenra 30 mg solution for injection in pre-filled syringe
Active Substance
BENRALIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised (EU/1/17/1252/001)
Starting Dose
30 mg
Dose Levels
30 mg
Investigational Product Name
Symbicort forte Turbuhaler 320 microgramos/9 microgramos/inhalación polvo para inhalación.
Active Substance
BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE
Modality
Small molecule
Routes Of Administration
INHALATION USE
Route
Inhalation
Authorisation Status
Authorised (product PRD399358 / national MA 65.044)
Starting Dose
320 microgramos/9 microgramos per inhalation (product strength)
Dose Levels
320/9 µg and 160/4.5 µg product variants available
Investigational Product Name
Symbicort Turbuhaler 160 microgramos/4,5 microgramos/inhalación polvo para inhalación
Active Substance
BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE
Modality
Small molecule
Routes Of Administration
INHALATION USE
Route
Inhalation
Authorisation Status
Authorised (product PRD399222 / national MA 63.958)
Starting Dose
160 microgramos/4.5 microgramos per inhalation (product strength)
Dose Levels
160/4.5 µg and 320/9 µg product variants available
Combination Treatment
Yes

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