Uno studio per verificare se una combinazione a dose fissa di fluticasone propionato/albuterolo solfato è efficace nel prevenire le riacutizzazioni dell'asma
2 novembre 2026 aggiornato da: Teva Branded Pharmaceutical Products R&D LLC
Uno studio randomizzato, in doppio cieco, multicentrico, con controllo attivo, a gruppi paralleli per valutare l'efficacia e la sicurezza della combinazione a dose fissa di fluticasone propionato/albuterolo solfato sulle riacutizzazioni gravi di asma in pazienti affetti da asma
The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs).
Secondary Objectives:
To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure
To evaluate the safety and tolerability of Fp/A BS
The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria
Panoramica dello studio
Stato
Stato
Attivo, non reclutante
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
Iscrizione
2769
Fase
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Bahía Blanca, Argentina, B8000JRB
- Instituto de Alergia e Inmunologia del Sur - IAIS
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Bahía Blanca, Argentina, B8001AAD
- CEC Consultorios de Especialidades Cardiovasculares
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Bahía Blanca, Argentina, B8001DDU
- Hospital Interzonal Dr Jose Penna Bahia Blanca
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Buenos Aires, Argentina, C1121ABE
- Fundacion CIDEA
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Buenos Aires, Argentina, C1128AAF
- Mautalen Salud e Investigacion
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Buenos Aires, Argentina, C1425BEN
- InAER
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Buenos Aires, Argentina, C1426ABP
- Consultorio Medico Dra. Rivera
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Buenos Aires, Argentina, C1426ABP
- Consultorios Medicos Dr. Doreski - Fundacion Respirar
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CABA, Argentina, 1414
- CARE - Centro de Alergia y Enfermedades Respiratorias
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CABA, Argentina, C1426ABP
- Fundacion Respirar-Consultorios Dr. Doreski
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Concepción del Uruguay, Argentina, 3260
- Centro de Medicina Respiratoria
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Córdoba, Argentina, X5003DCE
- Instituto de Medicina Respiratoria, IMeR
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Florida, Argentina, B1602DQD
- CEMER Centro Medico de Enfermedades Respiratorias
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Godoy Cruz, Argentina, 5501
- Respira Salud Clinica Integral
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Lanus, Argentina, 1824
- CIMeL
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Lobos, Argentina, B7240KJB
- CEMLO-Centro Especialidades Medicas Lobos
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Mar del Plata, Argentina, B7612ENA
- Fundacion Enfisema
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Mar del Plata, Argentina, 7600
- Centro de Investigaciones Medicas Mar del Plata (CIM-MDP)
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Mendoza, Argentina, 5500
- Fundacion Scherbovsky
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Mendoza, Argentina, M55000CBA
- Dharma Centro Medico
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Mendoza, Argentina, M5500CCA
- INSARES
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Mendoza, Argentina, M5507XAF
- Polo de Salud Vistalba
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Paraná, Argentina, E3100XAI
- Centro Privado de Medicina Respiratoria
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Quilmes, Argentina, 1878
- Centro Respiratorio Quilmes
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Rosario, Argentina, 2000
- Sanatorio Ipam
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Rosario, Argentina, S2000 DEJ
- Fundacion Estudios Clinicos (FECLIN)
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Rosario, Argentina, S2000JKR
- Instituto de Diagnostico ABC
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San Fernando, Argentina, B1646EBJ
- Centro Medico Respire
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San Juan Bautista, Argentina, 1888
- IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica
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San Miguel de Tucumán, Argentina, 4000
- Centro Integral de Medicina Respiratoria (CIMER)
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San Miguel de Tucumán, Argentina, 4000
- Clinica Mayo de UMCB SRL
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San Miguel de Tucumán, Argentina, 4000
- Investigaciones En Patologias Respiratorias
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San Miguel de Tucumán, Argentina, T4000EGH
- Centro Modelo de Cardiologa SRL
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San Rafael, Argentina, M5602GGS
- Cimro Consultorios Medicos - Centro de Investigacion
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Santa Fe, Argentina, S3000ASF
- Instituto del Buen Aire
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Box Hill, Australia, 3128
- Eastern Health, Box Hill Hospital
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Clayton, Australia, 3168
- Monash Health
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Melbourne, Australia, 3004
- Alfred Health
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Midland, Australia, 6056
- Institute for Respiratory Health - Midland
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Nedlands, Australia, 6009
- Institute for Respiratory Health ,Sir Charles Gairdner Hospital
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North Adelaide, Australia, 5006
- Women's and Children's Hospital (WCH)
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Parkville, Australia, 3052
- The Royal Children's Hospital Melbourne
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South Brisbane, Australia, 4101
- Centre for Childrens Health Research
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Blagoevgrad, Bulgaria, 2700
- Multiprofile Hospital for Active Treatment Puls AD
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Kozloduy, Bulgaria, 3320
- Medical Center Zdrave 1 - OOD
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Pernik, Bulgaria, 2300
- DCC-1 Pernik
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Pleven, Bulgaria, 5800
- Medical Center MedConsult Pleven OOD
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Plovdiv, Bulgaria, 4002
- UMHAT Sveti Georgi
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Plovdiv, Bulgaria, 4002
- Medical Center Dar Plovdiv OOD
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Rousse, Bulgaria, 7002
- SHATPPD - Ruse Pulmonary Hospital
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Sliven, Bulgaria, 8800
- Diagnostic - Consultative Center - Sliven OOD
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Sofia, Bulgaria, 1407
- Medical Center Excelsior
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Sofia, Bulgaria, 1408
- DCC NeoClinic
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Sofia, Bulgaria, 1142
- First MHAT - Sofia
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Sofia, Bulgaria, 1421
- AGPSMP Pediatric Diseases South Park OOD
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Sofia, Bulgaria, 1431
- DKC Alexandrovska EOOD
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Sofia, Bulgaria, 1680
- Diagnostic - Consultative Center Convex EOOD
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Stara Zagora, Bulgaria, 6001
- Medical Center New Rehabilitation Center Ltd
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Varna, Bulgaria, 9000
- MC Research expert
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Vratsa, Bulgaria, 3001
- Specialized Hospital for Active Treatment of Pneumo-Phtisiatric Diseases Vratsa EOOD (SHATPPD- Vratsa)
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Alberta
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Edmonton, Alberta, Canada, T6G2G3
- University of Alberta
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Ontario
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Ajax, Ontario, Canada, l1s2j5
- Dynamic Drug Advancement
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Etobicoke, Ontario, Canada, M9V 4B4
- Albion Finch Medical Centre
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Hamilton, Ontario, Canada, L8S 1G5
- Triple A Lab
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Winchester, Ontario, Canada, K0C 2K0
- Winchester Memorial Hospital
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Windsor, Ontario, Canada, N8X 2G1
- Joel Liem Medicine Professional Corporation
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Brandýs nad Labem-Stará Boleslav, Cechia, 25001
- MUDr. I. Cierna-Peterova s.r.o.
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Brno, Cechia, 60200
- Fakultni Nemocnice u Sv. Anny - FNUSA
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Jihlava, Cechia, 586 01
- Alergologie a imunologie MUDr. Hofstetr
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Jindřichův Hradec, Cechia, 37701
- MediTrial s.r.o.
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Lovosice, Cechia, 410 02
- CEFISPIRO s.r.o.
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Ostrava, Cechia, 70900
- Alergologie SKOPKOVA s.r.o.
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Prague, Cechia, 148 00
- Dawon s.r.o MU
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Varnsdorf, Cechia, 40747
- PNEUMOLOGIE VARNSDORF s.r.o.
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Seoul, Corea del Sud, 5505
- Asan Medical Center
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Seoul, Corea del Sud, 04763
- Hanyang University Seoul Hospital
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Seoul, Corea del Sud, 6591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Corea del Sud, 3722
- Yonsei University Health System - Severance Hospital
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Seoul, Corea del Sud, 1757
- Inje University Sanggye Paik Hospital
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Seoul, Corea del Sud, 3312
- The Catholic University of Korea - Eunpyeong St. Marys Hospital
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Aalborg, Danimarca, 9100
- Aalborg University Hospital
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Hvidovre, Danimarca, 2650
- Hvidovre Hospital
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Vejle, Danimarca, 7100
- Vejle Hospital
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Augsburg, Germania, 86150
- Zentrum fur Pneumologie und Onkologie am Diako
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Berlin, Germania, 10119
- Studienpraxis Berlin-Brandenburg
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Berlin, Germania, 10717
- Research Center for Medical Studies RCMS
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Berlin, Germania, 12159
- Institut fur Allergie-und Asthmaforschung Berlin
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Cottbus, Germania, D-03050
- MECS Cottbus GmbH
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Darmstadt, Germania, 65283
- Pneumostudien Darmstadt GmbH
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Delitzsch, Germania, 4509
- Klifeck GmbH
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Essen, Germania, 45239
- Universitaetsmedizin Essen, Ruhrlandklinik
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Frankfurt, Germania, 60596
- IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
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Frankfurt am Main, Germania, 60596
- Medaimun GmbH
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Hamburg, Germania, 20354
- Pneumologicum Hamburg
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Hamburg, Germania, 22299
- ME Clinical Respiratory Research Hamburg Gmbh
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Hamburg, Germania, 22335
- Praxis Dr. Groth
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Hanover, Germania, 30449
- Siteworks GmbH
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Ibbenbueren, Germania, 49477
- Gemeinschaftspraxis fur Pneumologie Allergologie und Schlafmedizin
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Karlsruhe, Germania, D-76137
- Zentrum fuer klinische Studien Karlsruhe
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Leipzig, Germania, 04347
- POIS Sachsen GmbH
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Leipzig, Germania, 4299
- BAG Prof. G. Hoheisel/Dr. A. Bonitz Praxis fur Pneumologie und Allergologie -Studienzentrum
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Mainz, Germania, 55128
- IKF Pneumologie Mainz
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München, Germania, 80539
- Pneumologie Odeonsplatz Dr. med. Jan Feimer
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München, Germania, 81241
- Pneumologisches Studienzentrum Munchen-West
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Neu-Isenburg, Germania, 63623
- Ballenberger, Freytag, Wenisch ? Institut fur klinische Forschung GmbH
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Neuss, Germania, 41469
- Office of Juergen Funck, Dr.med.
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Peine, Germania, 31224
- Studienzentrum Dr.Schlenska
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Wiesbaden, Germania, 65189
- Velocity Clinical Research Wiesbaden
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Witten, Germania, 58452
- Lungenpraxis Witten
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Alexandroupoli, Grecia, 68100
- University General Hospital of Alexandroupolis
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Athens, Grecia, 10675
- Evaggelismos General Hospital
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Athens, Grecia, 11527
- General Pediatric Hospital Panayioti ans Aglaias Kyriakou
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Heraklion, Grecia, 71500
- University General Hospital of Heraklion
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Larissa, Grecia, 41 110
- University General Hospital of Larissa
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Thessaloniki, Grecia, 54639
- Pulmonary Clinic - Athens Medical Center SA, Interbalkan Medical Center of Thessaloniki
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Thessaloniki, Grecia, 57 010
- General Hospital of 'Thessaloniki G. Papanikolaou'
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Ashkelon, Israele, 7830604
- Barzilai Medical Center
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Beersheba, Israele, 8457108
- Soroka University Medical Center
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Haifa, Israele, 3109601
- Rambam Health Care Campus - The Ruth Rappaport Children's Hospital
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Jerusalem, Israele, 9103102
- Shaare Zedek Medical Center - Pulmonary Institute
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Jerusalem, Israele, 9112010
- The Hadassah University Hospital-Ein Kerem - Institute of Pulmonology
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Petach Tikvah, Israele, 4920235
- Kipper Institute of Allergy and Immunology at Schneider Children's Medical Center of Israel
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Petah Tikva, Israele, 4941492
- Rabin Medical Center
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Rehovot, Israele, 7661041
- Kaplan Medical Center
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Tel Aviv, Israele, 6423906
- Tel Aviv Sourasky Medical Center - Ichilov
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Ferrara, Italia, 44124
- AOU Ferrara - Arcispedale S.Anna
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Padova, Italia, 35128
- Azienda Ospedale - Universita Padova
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Pisa, Italia, 56126
- Azienda Ospedaliero Universitaria Pisana
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Verona, Italia, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
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Verona, Italia, 37131
- Azienda Ospedaliera Universitaria Integrata Verona (AOUI)
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Balvi, Lettonia, LV-4501
- Balvu and Gulbenes Hospital Association
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Daugavpils, Lettonia, LV-5417
- Daugavpils Regional Hospital, Centre of Lung Diseases and Tuberculosis
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Jūrmala, Lettonia, LV-2015
- Health Center Association, Clinic Dubulti
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Riga, Lettonia, LV-1003
- The Centre of Investigation and Treatment of Allergic Diseases
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Riga, Lettonia, 1004
- LOR Clinic
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Riga, Lettonia, LV-1004
- Bernu KUS
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Riga, Lettonia, LV1010
- Consilium Medical
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Rēzekne, Lettonia, 4601
- Vevere Viktorija - Doctor's Practice in Pneumology and Allergology
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Chihuahua City, Messico, 31203
- Mediadvance Clinical
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Guadalajara, Messico, 44670
- PanAmerican Clinical Research - Guadalajara
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Guadalajara, Messico, 44100
- Instituto Jaliscience de Investigacion Clinica
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Monterrey, Messico, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzl
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Oaxaca City, Messico, 68000
- Oaxaca Site Management Organization S.C. (OSMO) - Investigacion Clinica
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Villahermosa, Messico, 86035
- Consultorio De Especialidad Alergologia Pediatrica
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Auckland, Nuova Zelanda, 1010
- Optimal Clinical Trials Ltd
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Auckland, Nuova Zelanda, 626
- Optimal Clinical Trials - North
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Christchurch, Nuova Zelanda, 8013
- PCRN Forte
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Dunedin, Nuova Zelanda, 9016
- Momentum Dunedin
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Hamilton, Nuova Zelanda, 3204
- Waikato Hospital
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Hamilton, Nuova Zelanda, 3200
- Lakeland Clinical Trials Waikato
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Hastings, Nuova Zelanda, 4122
- P3 Research Ltd
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Nelson, Nuova Zelanda, 7011
- PCRN - Tasman
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Rotorua, Nuova Zelanda, 3010
- PCRN Rotorua
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Tauranga, Nuova Zelanda, 3110
- Clinical Horizons New Zealand Limited
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Waikanae Beach, Nuova Zelanda, 5036
- P3 Research Kapiti
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Wellington, Nuova Zelanda, 6021
- MRINZ
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Bialystok, Polonia, 15-010
- Prywatny Gabinet Internistyczno - Alergologiczny
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Bialystok, Polonia, 15-430
- Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
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Bydgoszcz, Polonia, 85-796
- Centrum Medyczne Pratia Bydgoszcz
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Elblag, Polonia, 82-300
- Centrum Badan Klinicznych Agnieszka Mital
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Gdansk, Polonia, 80-214
- University Clinical Center Medical University of Gdansk
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Gdansk, Polonia, 80-344
- Clinica Vitae Sp. z o.o.
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Krakow, Polonia, 31-624
- Malopolskie Centrum Alergologii
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Krakow, Polonia, 31-141
- Nzoz Atopia
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Lodz, Polonia, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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Lublin, Polonia, 20-089
- Przychodnia Alergopneuma
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Lublin, Polonia, 20-095
- Alergotest s.c. Specjalistyczne Centrum Medyczne
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Maków Podhalański, Polonia, 34-220
- Makowskie Centrum Medyczne Hamernia Sp z oo
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Ostrowiec Świętokrzyski, Polonia, 27-400
- Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
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Poznan, Polonia, 60-693
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus
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Rzeszów, Polonia, 35-051
- Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
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Skierniewice, Polonia, 96-100
- Velocity Skierniewice spolka z ograniczona odpowiedzialnoscia
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Warsaw, Polonia, 00-632
- Centrum Zdrowia MDM
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Zawadzkie, Polonia, 47-120
- Centrum Medyczne Lucyna Andrzej Dymek S.C.
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Bacau, Romania, 600625
- Spital Pneumoftiziologi Bacau
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Bragadiru, Romania, 769764
- Angisan Grup srl
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Bucharest, Romania, 12052
- Quantum Medical Center
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Bucharest, Romania, 41507
- Marius Nasta Pneumoftiziology Institute
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Cluj-Napoca, Romania, 400371
- Spitalul Clinic de Pneumoftiziologie Leon Daniello
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Craiova, Romania, 200515
- Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes
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Belgrade, Serbia, 11080
- Clinical Hospital Center Zemun
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Belgrade, Serbia, 11070
- Mother and Child Health Institute of Serbia
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Belgrade, Serbia, 11000
- Cinic for pulmonary diseases, clinical center of Serbia
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Belgrade, Serbia, 11000
- Municipal Institute for Lung Diseases and Tuberculosis
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Belgrade, Serbia, 11000
- Univezitetska Decja Klinika Beograd (University Children's Hospital Belgrade)
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Kamenitz, Serbia, 21204
- Institut za plucne bolesti Vojvodine
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Kragujevac, Serbia, 34000
- Clinic for Pulmonology, University Clinical Center Kragujevac
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Niš, Serbia, 18000
- Clinical Centre of Nis,Clinic for Lung Diseases
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Novi Sad, Serbia, 21000
- Institute for Child and Youth Health Care
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Bardejov, Slovacchia, 08501
- Ns PSv. Jakuba
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Kežmarok, Slovacchia, 06224
- AlergoImuno centrum s.r.o. - Ambulancia alergologi
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Košice, Slovacchia, 040 11
- Paediatric University Hospital
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Rimavská Sobota, Slovacchia, 979 01
- Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie
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Spišská Nová Ves, Slovacchia, 052 01
- Plucna ambulancia Hrebenar, s.r.o.
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Žilina, Slovacchia, 01001
- Emin s.r.o.
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Žilina, Slovacchia, 1001
- Alergologicka a imunologicka ambulancia
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Badalona, Spagna, 8916
- Hospital Universitari Germans Trias I Pujol
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Barcelona, Spagna, 08017
- Pectus Respiratory Health (Giromed Institute)
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Barcelona, Spagna, 08035
- Hospital Materno Infantil, Planta 13
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Córdoba, Spagna, 14004
- Hopital Quironsalud Cordoba
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Madrid, Spagna, 28007
- Hospital General Universitario Gregorio Maranon
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Sabadell, Spagna, 8208
- Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
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Santiago de Compostela, Spagna, 15706
- Hospital Clinico Universitario de Santiago
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Seville, Spagna, 41013
- Hospital Universitario Virgen del Rocio
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Valencia, Spagna, 46015
- Hospital Arnau de Vilanova
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- The University of Alabama at Birmingham
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Birmingham, Alabama, Stati Uniti, 35209
- AllerVie Clnical Research
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Dothan, Alabama, Stati Uniti, 36305
- SEC Clinical Research
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Arizona
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Paradise Valley, Arizona, Stati Uniti, 85258
- One of a Kind Clinical Research Center LLC
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Scottsdale, Arizona, Stati Uniti, 85259
- Mayo Clinic
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Tucson, Arizona, Stati Uniti, 85741
- Novak Clinical Research
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California
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Bakersfield, California, Stati Uniti, 93301
- Kern Research, Inc
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Fresno, California, Stati Uniti, 93704
- Clinical Research of Central California, LLC
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Huntington Beach, California, Stati Uniti, 92647-6853
- Allergy and Asthma Specialists Medical Group
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La Jolla, California, Stati Uniti, 92037
- Orso Health
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La Palma, California, Stati Uniti, 90623
- IMAX Clinical Trials
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Long Beach, California, Stati Uniti, 90815
- Ark Clinical Research, LLC
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Long Beach, California, Stati Uniti, 90806-2613
- Long Beach Clinical Trials
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Los Angeles, California, Stati Uniti, 90025
- Ricardo Antonio Tan Inc
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Napa, California, Stati Uniti, 94558
- One of a Kind Clinical Research Center LLC
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Northridge, California, Stati Uniti, 91324
- California Medical Research Associates Inc.
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Redondo Beach, California, Stati Uniti, 90277-5720
- Riviera Allergy Medical Center
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San Bernardino, California, Stati Uniti, 92408
- Velocity Clinical Research, Banning
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San Diego, California, Stati Uniti, 92120
- Institute of HealthCare Assessment, Inc
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San Jose, California, Stati Uniti, 95117
- Allergy and Asthma Associates
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Stockton, California, Stati Uniti, 95207
- Bensch Clinical Research LLC
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Westminster, California, Stati Uniti, 92683
- Allianz Research Institute
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Colorado
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Aurora, Colorado, Stati Uniti, 80014
- Allianz Research Institute
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Colorado Springs, Colorado, Stati Uniti, 80907
- CRN Clinical Research Network LLC/Asthma and Allergy Associates P.C.
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Colorado Springs, Colorado, Stati Uniti, 80922
- OptumCare Colorado Springs LLC
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Englewood, Colorado, Stati Uniti, 80110
- Velocity Clinical Research
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District of Columbia
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Washington D.C., District of Columbia, Stati Uniti, 20009
- Emerson Clinical Research Institute
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Florida
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Aventura, Florida, Stati Uniti, 33180
- Florida Center for Allergy and Asthma Research
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Cape Coral, Florida, Stati Uniti, 33914
- Renaissance Research and Medical Group
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Cutler Bay, Florida, Stati Uniti, 33189
- Cenara Clinical Research
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Doral, Florida, Stati Uniti, 33122
- D & H Doral Research Centers
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Greenacres City, Florida, Stati Uniti, 33476
- Finlay Medical Research Corp
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Hialeah, Florida, Stati Uniti, 33012
- Direct Helpers Research Center, Inc.
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Hialeah, Florida, Stati Uniti, 33012
- New Life Research Institute, LLC
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Homestead, Florida, Stati Uniti, 33030
- Homestead Medical Research
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Jacksonville, Florida, Stati Uniti, 32207
- Nemours Children Clinic
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Leesburg, Florida, Stati Uniti, 34748
- Clinical Site Partner, LLC DBA Flourish Research
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Margate, Florida, Stati Uniti, 33063
- D & H Pompano Research Centers, Inc.
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Miami, Florida, Stati Uniti, 33126
- Finlay Medical Research
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Miami, Florida, Stati Uniti, 33144
- Bio-Medical Research LLC
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Miami, Florida, Stati Uniti, 33186
- Phoenix Research Center, LLC
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Miami, Florida, Stati Uniti, 33173
- Century Research LLC
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Miami, Florida, Stati Uniti, 33155
- D & H National Research Centers, Inc.
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Miami, Florida, Stati Uniti, 33143
- Florida Pharmaceutical Research and Associates
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Miami, Florida, Stati Uniti, 33126
- EMDA Clinical Research
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Miami, Florida, Stati Uniti, 33126
- Life Arc Research Centers
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Miami, Florida, Stati Uniti, 33130
- Care Research Center
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Miami, Florida, Stati Uniti, 33142-2946
- Acevedo Clinical Research Associates
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Miami, Florida, Stati Uniti, 33144
- Y&L Advance Health Care, Inc. d/b/a Elite Clinical Research
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Miami, Florida, Stati Uniti, 33173
- Advance Medical Research Practice
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Miami, Florida, Stati Uniti, 33173
- Florida Center for Allergy and Asthma Research
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Miami, Florida, Stati Uniti, 33175
- ITB Research
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Miami, Florida, Stati Uniti, 33176
- DY Professional Research Center
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Miami, Florida, Stati Uniti, 33176
- IMIC INC
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Miami Lakes, Florida, Stati Uniti, 33014
- San Marcus Research Clinic, Inc.
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Miami Lakes, Florida, Stati Uniti, 33016
- Quality Research of South Florida
-
Miami Lakes, Florida, Stati Uniti, 33014
- The Research Center
-
Oldsmar, Florida, Stati Uniti, 34677
- Journey Research Inc.
-
Orlando, Florida, Stati Uniti, 32819
- HMD Research LLC
-
Orlando, Florida, Stati Uniti, 32806
- Anderson Allergy And Asthma, PA
-
Orlando, Florida, Stati Uniti, 32825
- AHMG Pulmonology at East Orlando
-
Pembroke Pines, Florida, Stati Uniti, 33025
- Pines Care Research Center LLC
-
Sweetwater, Florida, Stati Uniti, 33182
- Cordova Research Institute, LLC
-
Tamarac, Florida, Stati Uniti, 33321
- TBC Research Corp
-
Tampa, Florida, Stati Uniti, 33604
- Wecare research center LLC
-
Tampa, Florida, Stati Uniti, 33607-6327
- Clinical Research Trials of Florida, Inc.
-
Tampa, Florida, Stati Uniti, 33607
- Nodal Medical Center, Llc
-
Virginia Gardens, Florida, Stati Uniti, 33166
- Hope Research Network/CBS Laboratory
-
Winter Park, Florida, Stati Uniti, 32789
- Florida Pediatric Research Institute
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30329
- Children's Healthcare of Atlanta Center for Advanced Pediatrics
-
Conyers, Georgia, Stati Uniti, 30012
- Oracle Clinical Research
-
Savannah, Georgia, Stati Uniti, 31406-2668
- Aeroallergy Research Laboratories of Savannah, Inc.
-
-
Idaho
-
Boise, Idaho, Stati Uniti, 83706
- Treasure Valley Medical Research
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60612
- Rush University Medical Center
-
Chicago, Illinois, Stati Uniti, 60637
- University of Chicago
-
Chicago, Illinois, Stati Uniti, 60607
- Cedar Crosse Research Center
-
Skokie, Illinois, Stati Uniti, 60077
- Northshore University Health System Clinical Trials Center
-
-
Indiana
-
Evansville, Indiana, Stati Uniti, 47715
- Deaconess Clinic
-
-
Kansas
-
Overland Park, Kansas, Stati Uniti, 66210
- Velocity Clinical Research, Kansas City
-
-
Kentucky
-
Lexington, Kentucky, Stati Uniti, 40509
- Bluegrass Allergy Research
-
-
Louisiana
-
Lafayette, Louisiana, Stati Uniti, 70508
- Velocity Clinical Research - Lafayette
-
-
Maine
-
Bangor, Maine, Stati Uniti, 04401
- Paul A. Shapero M.D.
-
-
Maryland
-
Rockville, Maryland, Stati Uniti, 20852
- DelRicht Research @ Matthew Mintz Clinic
-
White Marsh, Maryland, Stati Uniti, 21162
- Chesapeake Clinical Research Inc
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02115
- Brigham Womens Hospital
-
Fall River, Massachusetts, Stati Uniti, 02723
- Exordia Medical Research Inc,
-
North Dartmouth, Massachusetts, Stati Uniti, 02747
- Infinity Medical Research
-
South Dartmouth, Massachusetts, Stati Uniti, 02747
- Mayflower Clinical Research
-
-
Michigan
-
Detroit, Michigan, Stati Uniti, 48202
- Henry Ford
-
Flint, Michigan, Stati Uniti, 48507
- Onyx Clinical Research
-
Ypsilanti, Michigan, Stati Uniti, 48197
- Respiratory Medicine Research Institute of Michigan
-
-
Missouri
-
Kansas City, Missouri, Stati Uniti, 66160
- University of Kansas School of Medicine
-
St Louis, Missouri, Stati Uniti, 63110
- Washington University
-
St Louis, Missouri, Stati Uniti, 63123
- Clayton Sleep Institute
-
St Louis, Missouri, Stati Uniti, 63141-7068
- Midwest Clinical Research
-
-
Nebraska
-
Hastings, Nebraska, Stati Uniti, 68901
- Family Medical Center of Hastings
-
-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89123-2875
- American Institute of Medical Research
-
-
New Jersey
-
North Bergen, New Jersey, Stati Uniti, 07047
- Northern Valley Allergy, Asthma & Sinus Center
-
-
New York
-
Hawthorne, New York, Stati Uniti, 10532
- New York Medical College
-
Horseheads, New York, Stati Uniti, 14845
- Corning Center for Clinical Research
-
Hyde Park, New York, Stati Uniti, 11042
- Northwell Health Physician Partners
-
New Windsor, New York, Stati Uniti, 12553
- Mid Hudson Medical Research PLLC
-
-
North Carolina
-
Asheville, North Carolina, Stati Uniti, 28803
- Allergy Partners of WNC
-
Chapel Hill, North Carolina, Stati Uniti, 27599
- UNC Chapel Hill
-
Charlotte, North Carolina, Stati Uniti, 28277
- OnSite Clinical Solutions LLC
-
Elizabeth City, North Carolina, Stati Uniti, 27909-3465
- Atlantic Pulmonary Associates
-
High Point, North Carolina, Stati Uniti, 27260
- Peters Medical Research, LLC
-
Statesville, North Carolina, Stati Uniti, 28625
- Piedmont Healthcare, P.A.
-
Wilmington, North Carolina, Stati Uniti, 28401
- Accellacare of Wilmington
-
Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest Baptist Health
-
-
Ohio
-
Cincinnati, Ohio, Stati Uniti, 45236
- Bernstein Clinical Research Center
-
Columbus, Ohio, Stati Uniti, 43205
- Nationwide Childrens Hospital
-
Dayton, Ohio, Stati Uniti, 45429
- PriMed Clinical Research
-
Dayton, Ohio, Stati Uniti, 45404
- Daytons Children's Hospital
-
Toledo, Ohio, Stati Uniti, 43617
- Toledo Institute of Clinical Research Inc
-
Toledo, Ohio, Stati Uniti, 43606
- ProMedica Russell J. Ebeid Children's Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stati Uniti, 73120-9389
- Allergy Asthma Clinical Research Cent
-
Tulsa, Oklahoma, Stati Uniti, 74133
- Pulmonary & Sleep Center of Oklahoma
-
Yukon, Oklahoma, Stati Uniti, 73099
- Tekton Research
-
-
Oregon
-
Grants Pass, Oregon, Stati Uniti, 97527
- Velocity Clinical Research, Grants Pass
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19140
- Temple University Hospital
-
Pittsburgh, Pennsylvania, Stati Uniti, 15241
- Allergy and Clinical Immunology
-
-
South Carolina
-
North Charleston, South Carolina, Stati Uniti, 29420
- National Allergy and Asthma Research LLC.
-
Rock Hill, South Carolina, Stati Uniti, 29732
- Clinical Research of Rock Hill
-
-
Tennessee
-
Knoxville, Tennessee, Stati Uniti, 37909
- Allergy Associates, PA dba Allergy, Asthma & Sinus Center
-
-
Texas
-
Austin, Texas, Stati Uniti, 78759
- Orion Clinical Research
-
Boerne, Texas, Stati Uniti, 78006
- South Texas Medical Research Institute, Inc., DBA TTS Research
-
Brownsville, Texas, Stati Uniti, 78520
- PanAmerican Clinical Research Brownsville
-
Corsicana, Texas, Stati Uniti, 75110
- Corsicana Medical Research
-
Dallas, Texas, Stati Uniti, 75235
- Southwest Family Medicine Associates
-
Dallas, Texas, Stati Uniti, 75209
- Alina Clinical Trials, LLC, Barbara Baxter Sole MBR
-
Dallas, Texas, Stati Uniti, 75231-8206
- AARA Research Center
-
Edinburg, Texas, Stati Uniti, 78539
- Proactive Clinical Research LLC
-
El Paso, Texas, Stati Uniti, 79902
- El Paso Pulmonary Association
-
El Paso, Texas, Stati Uniti, 79912
- Western Sky Medical Research
-
El Paso, Texas, Stati Uniti, 79902
- Proactive el Paso, LLC
-
Houston, Texas, Stati Uniti, 77099
- Pioneer Research Solutions
-
Houston, Texas, Stati Uniti, 77008
- Trio Clinical Trials
-
Houston, Texas, Stati Uniti, 77065
- Innovative Medical Research of Texas LLC
-
Houston, Texas, Stati Uniti, 77030
- Texas Children's Allergy and Immunology, Houston
-
Houston, Texas, Stati Uniti, 77074-2005
- Clinical Trial Network
-
Katy, Texas, Stati Uniti, 77494
- R & H Clinical Research
-
Kerrville, Texas, Stati Uniti, 78028
- Sante Clinical Research LLC
-
McKinney, Texas, Stati Uniti, 75069
- Metroplex Pulmonary and Sleep Center Drive
-
San Antonio, Texas, Stati Uniti, 78229
- STAAMP Research, LLC
-
San Antonio, Texas, Stati Uniti, 78258
- Element Research Group
-
San Antonio, Texas, Stati Uniti, 78212
- Quality Assurance Research Center
-
Sherman, Texas, Stati Uniti, 75090
- Sherman Clinical Research
-
Splendora, Texas, Stati Uniti, 77372
- APD Clinical Research / PCP for Life
-
Tomball, Texas, Stati Uniti, 77081
- DM Clinical Tomball
-
Victoria, Texas, Stati Uniti, 77901
- Victoria Clinical Research Group
-
Waxahachie, Texas, Stati Uniti, 75165-1430
- ClinPoint Trials
-
-
Utah
-
Bountiful, Utah, Stati Uniti, 84010
- Pantheon Clinical Research
-
Sandy City, Utah, Stati Uniti, 84093
- Allergy Associates of Utah
-
West Valley City, Utah, Stati Uniti, 84119
- Chronicle Bio
-
-
Virginia
-
Williamsburg, Virginia, Stati Uniti, 23188
- Tidewater Physicians Multispecialty Group (TPMG) Clinical Research
-
-
Wisconsin
-
Greenfield, Wisconsin, Stati Uniti, 53228
- Allergy, Asthma & Sinus Center
-
-
-
-
-
Benoni, Sud Africa, 1501
- Worthwhile Clinical Trials
-
Cape Town, Sud Africa, 7530
- TASK Applied Science
-
Cape Town, Sud Africa, 7700
- University of Cape Town Lung Institute
-
Cape Town, Sud Africa, 7530
- Tiervlei Trial Centre
-
Cape Town, Sud Africa, 7570
- Langeberg Clinical Trials (*Medicross)
-
Centurion, Sud Africa, 0157
- Global Clinical Trials
-
Chatsworth, Sud Africa, 4092
- Precise Clinical Solutions
-
Durban, Sud Africa, 4092
- Dr PJ Sebastian
-
Ennerdale, Sud Africa, 1830
- Reimed Ennerdale
-
Germiston, Sud Africa, 1401
- CRISMO Bertha Gxowa Research Centre
-
Johannesburg, Sud Africa, 2113
- Newtown Clinical Research Centre
-
Krugersdorp, Sud Africa, 1739
- Ubuntu Clinical Research
-
KwaDukuza, Sud Africa, 4450
- Office of Jeevren Reddy MBChB
-
Middelburg, Sud Africa, 1050
- Merclinico
-
Midrand, Sud Africa, 1685
- Midrand Medical Centre
-
Plettenberg Bay, Sud Africa, 6600
- Tsitsikamma Clinical Research Initiative Unit 6,
-
Polokwane, Sud Africa, 699
- Gole Biomed Research Centre
-
Pretoria, Sud Africa, 0181
- Into Research
-
Roodepoort, Sud Africa, 1724
- Roodepoort Medicross Clinical Research Centre
-
Somerset West, Sud Africa, 7130
- Helderberg Clinical Research Centre - Somerset West
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Soweto, Sud Africa, 1868
- Bheki Mlangeni District Hospital
-
-
-
-
-
Budapest, Ungheria, 1033
- Clinexpert Kft
-
Budapest, Ungheria, 1094
- Semmelweis University
-
Budapest, Ungheria, 1027
- High Tech Medical Kft
-
Debrecen, Ungheria, 4027
- Orvostudomanyi Kutato es Fejleszto Kft.
-
Mosonmagyaróvár, Ungheria, 9200
- Omnimodus Elixir KFT.
-
Pécs, Ungheria, 7635
- Infer-Med Kft.
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Szeged, Ungheria, 6720
- Aranyklinika
-
Szigetvár, Ungheria, 7900
- Spiroped Szigetvar Kft.
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
4 anni e precedenti (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- The participant has a documented diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines.
- The participant has a documented history of at least 1 severe clinical asthma exacerbation (CAE) ending within the past 12 month.
- The participant is using any prescribed inhaled asthma controller medication (at a stable dose for 1 month prior to the screening visit).
- If female, the participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit and throughout the duration of the study), or is of nonchildbearing potential
NOTE- Additional criteria apply, please contact the investigator for more information.
Exclusion Criteria:
- The participant has life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years before screening.
- The participant has a suspected bacterial or viral infection (other than Coronavirus Disease [COVID-19]) of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period.
- Participants with a confirmed infection with COVID-19 within 6 weeks prior to the screening visit, or with residual COVID-19 symptoms ("long COVID-19").
- The participant has had a clinical asthma exacerbation (CAE) requiring systemic corticosteroids within 30 days before screening, or any hospitalization for asthma within 2 months before screening.
- The participant is a current smoker and/or has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months.
- The participant has significantly abused alcohol and/or illicit prohibited drugs within the previous 24 months.
- The participant has participated as a randomized participant in any investigational drug study within 30 days.
- The participant has been hospitalized for psychiatric disorder or attempted suicide within 1 year of screening.
NOTE- Additional criteria apply, please contact the investigator for more information
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
3
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: TEV-56248 30/117 mcg
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms. |
Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder. |
|
Sperimentale: TEV-56248 55/117 mcg
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms. |
Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder. |
|
Comparatore attivo: Albuterol sulfate 117 mcg
Inhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms. |
Oral inhalation powder |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Tempo alla Prima Esacerbazione Clinica Grave di Asma (CAE) con Fp/ABS eMDPI ad Alta Dose (HD)
Lasso di tempo: Fino a 42 mesi
|
Fino a 42 mesi
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tempo fino al primo evento avverso grave con dose bassa (LD) di Fp/ABS eMDPI
Lasso di tempo: Fino a 42 mesi
|
Fino a 42 mesi
|
|
|
Numero di partecipanti con almeno un evento avverso grave
Lasso di tempo: Fino a 42 mesi
|
Fino a 42 mesi
|
|
|
Numero di partecipanti che hanno interrotto la sperimentazione a causa di eventi avversi insorti durante il trattamento
Lasso di tempo: Fino a 42 mesi
|
Fino a 42 mesi
|
|
|
Annualized Severe CAE Rate
Lasso di tempo: Up to 42 months
|
Annualized severe CAE rate is calculated for each participant as the sum of total number of CAE events divided by the duration of follow up time (years). |
Up to 42 months
|
|
Total Annualized SCS Exposure Over the Treatment Period
Lasso di tempo: Up to 42 months
|
Total annualized SCS exposure will be calculated for each participant as the sum of the cumulative doses of SCS divided by the duration of time (years) the participant was in the treatment period, from randomization and up to end of treatment. |
Up to 42 months
|
|
Asthma Control Questionnaire-5 (ACQ-5) Response
Lasso di tempo: Baseline, Week 24
|
Response is defined as achieving a decrease in score from baseline value of at least 0.5 (participants aged ≥6 years). The ACQ-5 is a shortened version of the validated asthma assessment tool (ie, ACQ) and includes 5 questions that are self-assessments (completed by the participant). Each item on the ACQ-5 has a possible score ranging from 0 to 6, and the total score is the mean of all responses. |
Baseline, Week 24
|
|
Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)
Lasso di tempo: Baseline, Week 24
|
Responders are defined as the composite of participants achieving an increase in score from baseline of at least 0.5 on the AQLQ+12 or PAQLQ (participants aged ≥7 years). The AQLQ + 12 is a modified version of the standardized AQLQ, which was developed to measure functional impairments experienced by adults ≥17 years of age. The AQLQ + 12 is valid for participants aged 12 to 70 years and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Responses are rated on a 7-point scale where 7 = no impairment and 1 = severe impairment. The PAQLQ Questionnaire includes 23 items in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered). It is intended for participants ages 7-11. |
Baseline, Week 24
|
|
Number of Participants with at Least One Adverse Event
Lasso di tempo: Up to 42 months
|
Adverse events include clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), and 12-lead electrocardiogram (ECG) findings. |
Up to 42 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
30 agosto 2023
Completamento primario (Stimato)
Completamento primario
31 dicembre 2026
Completamento dello studio (Stimato)
Completamento dello studio
31 dicembre 2026
Date di iscrizione allo studio
Primo inviato
Primo inviato
18 settembre 2023
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
18 settembre 2023
Primo Inserito (Effettivo)
Primo Inserito
25 settembre 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
4 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 novembre 2026
Ultimo verificato
Ultimo verificato
1 novembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Malattie delle vie respiratorie
- Malattie polmonari
- Malattie bronchiali
- Malattie polmonari, ostruttive
- Ipersensibilità respiratoria
- Ipersensibilità, immediata
- Ipersensibilità
- Asma
- Prodotti chimici organici
- Ammine
- Alcoli
- Aminouli
- Etanolamine
- Fenetilammine
- Etilammine
- Salbutamolo
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- FpA-AS-30094
- 2023-505435-12-00 (Identificatore di registro: CTIS (EU))
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .