Une étude pour tester si une association à dose fixe de propionate de fluticasone/sulfate d'albutérol est efficace pour prévenir les exacerbations de l'asthme
2 novembre 2026 mis à jour par: Teva Branded Pharmaceutical Products R&D LLC
Une étude randomisée, en double aveugle, multicentrique, contrôlée activement, en groupes parallèles pour évaluer l'efficacité et l'innocuité de l'association à dose fixe de propionate de fluticasone/sulfate d'albutérol sur les exacerbations sévères de l'asthme chez les patients asthmatiques
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
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
2769
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Benoni, Afrique du Sud, 1501
- Worthwhile Clinical Trials
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Cape Town, Afrique du Sud, 7530
- TASK Applied Science
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Cape Town, Afrique du Sud, 7700
- University of Cape Town Lung Institute
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Cape Town, Afrique du Sud, 7530
- Tiervlei Trial Centre
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Cape Town, Afrique du Sud, 7570
- Langeberg Clinical Trials (*Medicross)
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Centurion, Afrique du Sud, 0157
- Global Clinical Trials
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Chatsworth, Afrique du Sud, 4092
- Precise Clinical Solutions
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Durban, Afrique du Sud, 4092
- Dr PJ Sebastian
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Ennerdale, Afrique du Sud, 1830
- Reimed Ennerdale
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Germiston, Afrique du Sud, 1401
- CRISMO Bertha Gxowa Research Centre
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Johannesburg, Afrique du Sud, 2113
- Newtown Clinical Research Centre
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Krugersdorp, Afrique du Sud, 1739
- Ubuntu Clinical Research
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KwaDukuza, Afrique du Sud, 4450
- Office of Jeevren Reddy MBChB
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Middelburg, Afrique du Sud, 1050
- Merclinico
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Midrand, Afrique du Sud, 1685
- Midrand Medical Centre
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Plettenberg Bay, Afrique du Sud, 6600
- Tsitsikamma Clinical Research Initiative Unit 6,
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Polokwane, Afrique du Sud, 699
- Gole Biomed Research Centre
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Pretoria, Afrique du Sud, 0181
- Into Research
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Roodepoort, Afrique du Sud, 1724
- Roodepoort Medicross Clinical Research Centre
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Somerset West, Afrique du Sud, 7130
- Helderberg Clinical Research Centre - Somerset West
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Soweto, Afrique du Sud, 1868
- Bheki Mlangeni District Hospital
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Augsburg, Allemagne, 86150
- Zentrum fur Pneumologie und Onkologie am Diako
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Berlin, Allemagne, 10119
- Studienpraxis Berlin-Brandenburg
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Berlin, Allemagne, 10717
- Research Center for Medical Studies RCMS
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Berlin, Allemagne, 12159
- Institut fur Allergie-und Asthmaforschung Berlin
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Cottbus, Allemagne, D-03050
- MECS Cottbus GmbH
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Darmstadt, Allemagne, 65283
- Pneumostudien Darmstadt GmbH
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Delitzsch, Allemagne, 4509
- Klifeck GmbH
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Essen, Allemagne, 45239
- Universitaetsmedizin Essen, Ruhrlandklinik
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Frankfurt, Allemagne, 60596
- IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
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Frankfurt am Main, Allemagne, 60596
- Medaimun GmbH
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Hamburg, Allemagne, 20354
- Pneumologicum Hamburg
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Hamburg, Allemagne, 22299
- ME Clinical Respiratory Research Hamburg Gmbh
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Hamburg, Allemagne, 22335
- Praxis Dr. Groth
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Hanover, Allemagne, 30449
- Siteworks GmbH
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Ibbenbueren, Allemagne, 49477
- Gemeinschaftspraxis fur Pneumologie Allergologie und Schlafmedizin
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Karlsruhe, Allemagne, D-76137
- Zentrum fuer klinische Studien Karlsruhe
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Leipzig, Allemagne, 04347
- POIS Sachsen GmbH
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Leipzig, Allemagne, 4299
- BAG Prof. G. Hoheisel/Dr. A. Bonitz Praxis fur Pneumologie und Allergologie -Studienzentrum
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Mainz, Allemagne, 55128
- IKF Pneumologie Mainz
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München, Allemagne, 80539
- Pneumologie Odeonsplatz Dr. med. Jan Feimer
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München, Allemagne, 81241
- Pneumologisches Studienzentrum Munchen-West
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Neu-Isenburg, Allemagne, 63623
- Ballenberger, Freytag, Wenisch ? Institut fur klinische Forschung GmbH
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Neuss, Allemagne, 41469
- Office of Juergen Funck, Dr.med.
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Peine, Allemagne, 31224
- Studienzentrum Dr.Schlenska
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Wiesbaden, Allemagne, 65189
- Velocity Clinical Research Wiesbaden
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Witten, Allemagne, 58452
- Lungenpraxis Witten
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Bahía Blanca, Argentine, B8000JRB
- Instituto de Alergia e Inmunologia del Sur - IAIS
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Bahía Blanca, Argentine, B8001AAD
- CEC Consultorios de Especialidades Cardiovasculares
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Bahía Blanca, Argentine, B8001DDU
- Hospital Interzonal Dr Jose Penna Bahia Blanca
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Buenos Aires, Argentine, C1121ABE
- Fundacion CIDEA
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Buenos Aires, Argentine, C1128AAF
- Mautalen Salud e Investigacion
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Buenos Aires, Argentine, C1425BEN
- InAER
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Buenos Aires, Argentine, C1426ABP
- Consultorio Medico Dra. Rivera
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Buenos Aires, Argentine, C1426ABP
- Consultorios Medicos Dr. Doreski - Fundacion Respirar
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CABA, Argentine, 1414
- CARE - Centro de Alergia y Enfermedades Respiratorias
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CABA, Argentine, C1426ABP
- Fundacion Respirar-Consultorios Dr. Doreski
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Concepción del Uruguay, Argentine, 3260
- Centro de Medicina Respiratoria
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Córdoba, Argentine, X5003DCE
- Instituto de Medicina Respiratoria, IMeR
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Florida, Argentine, B1602DQD
- CEMER Centro Medico de Enfermedades Respiratorias
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Godoy Cruz, Argentine, 5501
- Respira Salud Clinica Integral
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Lanus, Argentine, 1824
- CIMeL
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Lobos, Argentine, B7240KJB
- CEMLO-Centro Especialidades Medicas Lobos
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Mar del Plata, Argentine, B7612ENA
- Fundacion Enfisema
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Mar del Plata, Argentine, 7600
- Centro de Investigaciones Medicas Mar del Plata (CIM-MDP)
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Mendoza, Argentine, 5500
- Fundacion Scherbovsky
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Mendoza, Argentine, M55000CBA
- Dharma Centro Medico
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Mendoza, Argentine, M5500CCA
- INSARES
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Mendoza, Argentine, M5507XAF
- Polo de Salud Vistalba
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Paraná, Argentine, E3100XAI
- Centro Privado de Medicina Respiratoria
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Quilmes, Argentine, 1878
- Centro Respiratorio Quilmes
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Rosario, Argentine, 2000
- Sanatorio Ipam
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Rosario, Argentine, S2000 DEJ
- Fundacion Estudios Clinicos (FECLIN)
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Rosario, Argentine, S2000JKR
- Instituto de Diagnostico ABC
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San Fernando, Argentine, B1646EBJ
- Centro Medico Respire
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San Juan Bautista, Argentine, 1888
- IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica
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San Miguel de Tucumán, Argentine, 4000
- Centro Integral de Medicina Respiratoria (CIMER)
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San Miguel de Tucumán, Argentine, 4000
- Clinica Mayo de UMCB SRL
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San Miguel de Tucumán, Argentine, 4000
- Investigaciones En Patologias Respiratorias
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San Miguel de Tucumán, Argentine, T4000EGH
- Centro Modelo de Cardiologa SRL
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San Rafael, Argentine, M5602GGS
- Cimro Consultorios Medicos - Centro de Investigacion
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Santa Fe, Argentine, S3000ASF
- Instituto del Buen Aire
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Box Hill, Australie, 3128
- Eastern Health, Box Hill Hospital
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Clayton, Australie, 3168
- Monash Health
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Melbourne, Australie, 3004
- Alfred Health
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Midland, Australie, 6056
- Institute for Respiratory Health - Midland
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Nedlands, Australie, 6009
- Institute for Respiratory Health ,Sir Charles Gairdner Hospital
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North Adelaide, Australie, 5006
- Women's and Children's Hospital (WCH)
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Parkville, Australie, 3052
- The Royal Children's Hospital Melbourne
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South Brisbane, Australie, 4101
- Centre for Childrens Health Research
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Blagoevgrad, Bulgarie, 2700
- Multiprofile Hospital for Active Treatment Puls AD
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Kozloduy, Bulgarie, 3320
- Medical Center Zdrave 1 - OOD
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Pernik, Bulgarie, 2300
- DCC-1 Pernik
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Pleven, Bulgarie, 5800
- Medical Center MedConsult Pleven OOD
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Plovdiv, Bulgarie, 4002
- UMHAT Sveti Georgi
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Plovdiv, Bulgarie, 4002
- Medical Center Dar Plovdiv OOD
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Rousse, Bulgarie, 7002
- SHATPPD - Ruse Pulmonary Hospital
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Sliven, Bulgarie, 8800
- Diagnostic - Consultative Center - Sliven OOD
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Sofia, Bulgarie, 1407
- Medical Center Excelsior
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Sofia, Bulgarie, 1408
- DCC NeoClinic
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Sofia, Bulgarie, 1142
- First MHAT - Sofia
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Sofia, Bulgarie, 1421
- AGPSMP Pediatric Diseases South Park OOD
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Sofia, Bulgarie, 1431
- DKC Alexandrovska EOOD
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Sofia, Bulgarie, 1680
- Diagnostic - Consultative Center Convex EOOD
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Stara Zagora, Bulgarie, 6001
- Medical Center New Rehabilitation Center Ltd
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Varna, Bulgarie, 9000
- MC Research expert
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Vratsa, Bulgarie, 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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Seoul, Corée du Sud, 5505
- Asan Medical Center
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Seoul, Corée du Sud, 04763
- Hanyang University Seoul Hospital
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Seoul, Corée du Sud, 6591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Corée du Sud, 3722
- Yonsei University Health System - Severance Hospital
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Seoul, Corée du Sud, 1757
- Inje University Sanggye Paik Hospital
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Seoul, Corée du Sud, 3312
- The Catholic University of Korea - Eunpyeong St. Marys Hospital
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Aalborg, Danemark, 9100
- Aalborg University Hospital
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Hvidovre, Danemark, 2650
- Hvidovre Hospital
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Vejle, Danemark, 7100
- Vejle Hospital
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Badalona, Espagne, 8916
- Hospital Universitari Germans Trias I Pujol
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Barcelona, Espagne, 08017
- Pectus Respiratory Health (Giromed Institute)
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Barcelona, Espagne, 08035
- Hospital Materno Infantil, Planta 13
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Córdoba, Espagne, 14004
- Hopital Quironsalud Cordoba
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Madrid, Espagne, 28007
- Hospital General Universitario Gregorio Maranon
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Sabadell, Espagne, 8208
- Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
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Santiago de Compostela, Espagne, 15706
- Hospital Clinico Universitario de Santiago
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Seville, Espagne, 41013
- Hospital Universitario Virgen del Rocio
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Valencia, Espagne, 46015
- Hospital Arnau de Vilanova
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Alexandroupoli, Grèce, 68100
- University General Hospital of Alexandroupolis
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Athens, Grèce, 10675
- Evaggelismos General Hospital
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Athens, Grèce, 11527
- General Pediatric Hospital Panayioti ans Aglaias Kyriakou
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Heraklion, Grèce, 71500
- University General Hospital of Heraklion
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Larissa, Grèce, 41 110
- University General Hospital of Larissa
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Thessaloniki, Grèce, 54639
- Pulmonary Clinic - Athens Medical Center SA, Interbalkan Medical Center of Thessaloniki
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Thessaloniki, Grèce, 57 010
- General Hospital of 'Thessaloniki G. Papanikolaou'
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Budapest, Hongrie, 1033
- Clinexpert Kft
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Budapest, Hongrie, 1094
- Semmelweis University
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Budapest, Hongrie, 1027
- High Tech Medical Kft
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Debrecen, Hongrie, 4027
- Orvostudomanyi Kutato es Fejleszto Kft.
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Mosonmagyaróvár, Hongrie, 9200
- Omnimodus Elixir KFT.
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Pécs, Hongrie, 7635
- Infer-Med Kft.
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Szeged, Hongrie, 6720
- Aranyklinika
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Szigetvár, Hongrie, 7900
- Spiroped Szigetvar Kft.
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Ashkelon, Israël, 7830604
- Barzilai Medical Center
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Beersheba, Israël, 8457108
- Soroka University Medical Center
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Haifa, Israël, 3109601
- Rambam Health Care Campus - The Ruth Rappaport Children's Hospital
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Jerusalem, Israël, 9103102
- Shaare Zedek Medical Center - Pulmonary Institute
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Jerusalem, Israël, 9112010
- The Hadassah University Hospital-Ein Kerem - Institute of Pulmonology
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Petach Tikvah, Israël, 4920235
- Kipper Institute of Allergy and Immunology at Schneider Children's Medical Center of Israel
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Petah Tikva, Israël, 4941492
- Rabin Medical Center
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Rehovot, Israël, 7661041
- Kaplan Medical Center
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Tel Aviv, Israël, 6423906
- Tel Aviv Sourasky Medical Center - Ichilov
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Ferrara, Italie, 44124
- AOU Ferrara - Arcispedale S.Anna
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Padova, Italie, 35128
- Azienda Ospedale - Universita Padova
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Pisa, Italie, 56126
- Azienda Ospedaliero Universitaria Pisana
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Verona, Italie, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
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Verona, Italie, 37131
- Azienda Ospedaliera Universitaria Integrata Verona (AOUI)
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Balvi, Lettonie, LV-4501
- Balvu and Gulbenes Hospital Association
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Daugavpils, Lettonie, LV-5417
- Daugavpils Regional Hospital, Centre of Lung Diseases and Tuberculosis
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Jūrmala, Lettonie, LV-2015
- Health Center Association, Clinic Dubulti
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Riga, Lettonie, LV-1003
- The Centre of Investigation and Treatment of Allergic Diseases
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Riga, Lettonie, 1004
- LOR Clinic
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Riga, Lettonie, LV-1004
- Bernu KUS
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Riga, Lettonie, LV1010
- Consilium Medical
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Rēzekne, Lettonie, 4601
- Vevere Viktorija - Doctor's Practice in Pneumology and Allergology
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Chihuahua City, Mexique, 31203
- Mediadvance Clinical
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Guadalajara, Mexique, 44670
- PanAmerican Clinical Research - Guadalajara
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Guadalajara, Mexique, 44100
- Instituto Jaliscience de Investigacion Clinica
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Monterrey, Mexique, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzl
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Oaxaca City, Mexique, 68000
- Oaxaca Site Management Organization S.C. (OSMO) - Investigacion Clinica
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Villahermosa, Mexique, 86035
- Consultorio De Especialidad Alergologia Pediatrica
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Auckland, Nouvelle-Zélande, 1010
- Optimal Clinical Trials Ltd
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Auckland, Nouvelle-Zélande, 626
- Optimal Clinical Trials - North
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Christchurch, Nouvelle-Zélande, 8013
- PCRN Forte
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Dunedin, Nouvelle-Zélande, 9016
- Momentum Dunedin
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Hamilton, Nouvelle-Zélande, 3204
- Waikato Hospital
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Hamilton, Nouvelle-Zélande, 3200
- Lakeland Clinical Trials Waikato
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Hastings, Nouvelle-Zélande, 4122
- P3 Research Ltd
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Nelson, Nouvelle-Zélande, 7011
- PCRN - Tasman
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Rotorua, Nouvelle-Zélande, 3010
- PCRN Rotorua
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Tauranga, Nouvelle-Zélande, 3110
- Clinical Horizons New Zealand Limited
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Waikanae Beach, Nouvelle-Zélande, 5036
- P3 Research Kapiti
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Wellington, Nouvelle-Zélande, 6021
- MRINZ
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Bialystok, Pologne, 15-010
- Prywatny Gabinet Internistyczno - Alergologiczny
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Bialystok, Pologne, 15-430
- Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
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Bydgoszcz, Pologne, 85-796
- Centrum Medyczne Pratia Bydgoszcz
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Elblag, Pologne, 82-300
- Centrum Badan Klinicznych Agnieszka Mital
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Gdansk, Pologne, 80-214
- University Clinical Center Medical University of Gdansk
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Gdansk, Pologne, 80-344
- Clinica Vitae Sp. z o.o.
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Krakow, Pologne, 31-624
- Malopolskie Centrum Alergologii
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Krakow, Pologne, 31-141
- Nzoz Atopia
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Lodz, Pologne, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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Lublin, Pologne, 20-089
- Przychodnia Alergopneuma
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Lublin, Pologne, 20-095
- Alergotest s.c. Specjalistyczne Centrum Medyczne
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Maków Podhalański, Pologne, 34-220
- Makowskie Centrum Medyczne Hamernia Sp z oo
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Ostrowiec Świętokrzyski, Pologne, 27-400
- Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
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Poznan, Pologne, 60-693
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus
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Rzeszów, Pologne, 35-051
- Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
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Skierniewice, Pologne, 96-100
- Velocity Skierniewice spolka z ograniczona odpowiedzialnoscia
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Warsaw, Pologne, 00-632
- Centrum Zdrowia MDM
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Zawadzkie, Pologne, 47-120
- Centrum Medyczne Lucyna Andrzej Dymek S.C.
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Bacau, Roumanie, 600625
- Spital Pneumoftiziologi Bacau
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Bragadiru, Roumanie, 769764
- Angisan Grup srl
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Bucharest, Roumanie, 12052
- Quantum Medical Center
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Bucharest, Roumanie, 41507
- Marius Nasta Pneumoftiziology Institute
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Cluj-Napoca, Roumanie, 400371
- Spitalul Clinic de Pneumoftiziologie Leon Daniello
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Craiova, Roumanie, 200515
- Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes
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Belgrade, Serbie, 11080
- Clinical Hospital Center Zemun
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Belgrade, Serbie, 11070
- Mother and Child Health Institute of Serbia
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Belgrade, Serbie, 11000
- Cinic for pulmonary diseases, clinical center of Serbia
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Belgrade, Serbie, 11000
- Municipal Institute for Lung Diseases and Tuberculosis
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Belgrade, Serbie, 11000
- Univezitetska Decja Klinika Beograd (University Children's Hospital Belgrade)
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Kamenitz, Serbie, 21204
- Institut za plucne bolesti Vojvodine
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Kragujevac, Serbie, 34000
- Clinic for Pulmonology, University Clinical Center Kragujevac
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Niš, Serbie, 18000
- Clinical Centre of Nis,Clinic for Lung Diseases
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Novi Sad, Serbie, 21000
- Institute for Child and Youth Health Care
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Bardejov, Slovaquie, 08501
- Ns PSv. Jakuba
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Kežmarok, Slovaquie, 06224
- AlergoImuno centrum s.r.o. - Ambulancia alergologi
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Košice, Slovaquie, 040 11
- Paediatric University Hospital
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Rimavská Sobota, Slovaquie, 979 01
- Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie
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Spišská Nová Ves, Slovaquie, 052 01
- Plucna ambulancia Hrebenar, s.r.o.
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Žilina, Slovaquie, 01001
- Emin s.r.o.
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Žilina, Slovaquie, 1001
- Alergologicka a imunologicka ambulancia
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Brandýs nad Labem-Stará Boleslav, Tchéquie, 25001
- MUDr. I. Cierna-Peterova s.r.o.
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Brno, Tchéquie, 60200
- Fakultni Nemocnice u Sv. Anny - FNUSA
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Jihlava, Tchéquie, 586 01
- Alergologie a imunologie MUDr. Hofstetr
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Jindřichův Hradec, Tchéquie, 37701
- MediTrial s.r.o.
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Lovosice, Tchéquie, 410 02
- CEFISPIRO s.r.o.
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Ostrava, Tchéquie, 70900
- Alergologie SKOPKOVA s.r.o.
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Prague, Tchéquie, 148 00
- Dawon s.r.o MU
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Varnsdorf, Tchéquie, 40747
- PNEUMOLOGIE VARNSDORF s.r.o.
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- The University of Alabama at Birmingham
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Birmingham, Alabama, États-Unis, 35209
- AllerVie Clnical Research
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Dothan, Alabama, États-Unis, 36305
- SEC Clinical Research
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Arizona
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Paradise Valley, Arizona, États-Unis, 85258
- One of a Kind Clinical Research Center LLC
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Scottsdale, Arizona, États-Unis, 85259
- Mayo Clinic
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Tucson, Arizona, États-Unis, 85741
- Novak Clinical Research
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California
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Bakersfield, California, États-Unis, 93301
- Kern Research, Inc
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Fresno, California, États-Unis, 93704
- Clinical Research of Central California, LLC
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Huntington Beach, California, États-Unis, 92647-6853
- Allergy and Asthma Specialists Medical Group
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La Jolla, California, États-Unis, 92037
- Orso Health
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La Palma, California, États-Unis, 90623
- IMAX Clinical Trials
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Long Beach, California, États-Unis, 90815
- Ark Clinical Research, LLC
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Long Beach, California, États-Unis, 90806-2613
- Long Beach Clinical Trials
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Los Angeles, California, États-Unis, 90025
- Ricardo Antonio Tan Inc
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Napa, California, États-Unis, 94558
- One of a Kind Clinical Research Center LLC
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Northridge, California, États-Unis, 91324
- California Medical Research Associates Inc.
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Redondo Beach, California, États-Unis, 90277-5720
- Riviera Allergy Medical Center
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San Bernardino, California, États-Unis, 92408
- Velocity Clinical Research, Banning
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San Diego, California, États-Unis, 92120
- Institute of HealthCare Assessment, Inc
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San Jose, California, États-Unis, 95117
- Allergy and Asthma Associates
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Stockton, California, États-Unis, 95207
- Bensch Clinical Research LLC
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Westminster, California, États-Unis, 92683
- Allianz Research Institute
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Colorado
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Aurora, Colorado, États-Unis, 80014
- Allianz Research Institute
-
Colorado Springs, Colorado, États-Unis, 80907
- CRN Clinical Research Network LLC/Asthma and Allergy Associates P.C.
-
Colorado Springs, Colorado, États-Unis, 80922
- OptumCare Colorado Springs LLC
-
Englewood, Colorado, États-Unis, 80110
- Velocity Clinical Research
-
-
District of Columbia
-
Washington D.C., District of Columbia, États-Unis, 20009
- Emerson Clinical Research Institute
-
-
Florida
-
Aventura, Florida, États-Unis, 33180
- Florida Center for Allergy and Asthma Research
-
Cape Coral, Florida, États-Unis, 33914
- Renaissance Research and Medical Group
-
Cutler Bay, Florida, États-Unis, 33189
- Cenara Clinical Research
-
Doral, Florida, États-Unis, 33122
- D & H Doral Research Centers
-
Greenacres City, Florida, États-Unis, 33476
- Finlay Medical Research Corp
-
Hialeah, Florida, États-Unis, 33012
- Direct Helpers Research Center, Inc.
-
Hialeah, Florida, États-Unis, 33012
- New Life Research Institute, LLC
-
Homestead, Florida, États-Unis, 33030
- Homestead Medical Research
-
Jacksonville, Florida, États-Unis, 32207
- Nemours Children Clinic
-
Leesburg, Florida, États-Unis, 34748
- Clinical Site Partner, LLC DBA Flourish Research
-
Margate, Florida, États-Unis, 33063
- D & H Pompano Research Centers, Inc.
-
Miami, Florida, États-Unis, 33126
- Finlay Medical Research
-
Miami, Florida, États-Unis, 33144
- Bio-Medical Research LLC
-
Miami, Florida, États-Unis, 33186
- Phoenix Research Center, LLC
-
Miami, Florida, États-Unis, 33173
- Century Research LLC
-
Miami, Florida, États-Unis, 33155
- D & H National Research Centers, Inc.
-
Miami, Florida, États-Unis, 33143
- Florida Pharmaceutical Research and Associates
-
Miami, Florida, États-Unis, 33126
- EMDA Clinical Research
-
Miami, Florida, États-Unis, 33126
- Life Arc Research Centers
-
Miami, Florida, États-Unis, 33130
- Care Research Center
-
Miami, Florida, États-Unis, 33142-2946
- Acevedo Clinical Research Associates
-
Miami, Florida, États-Unis, 33144
- Y&L Advance Health Care, Inc. d/b/a Elite Clinical Research
-
Miami, Florida, États-Unis, 33173
- Advance Medical Research Practice
-
Miami, Florida, États-Unis, 33173
- Florida Center for Allergy and Asthma Research
-
Miami, Florida, États-Unis, 33175
- ITB Research
-
Miami, Florida, États-Unis, 33176
- DY Professional Research Center
-
Miami, Florida, États-Unis, 33176
- IMIC INC
-
Miami Lakes, Florida, États-Unis, 33014
- San Marcus Research Clinic, Inc.
-
Miami Lakes, Florida, États-Unis, 33016
- Quality Research of South Florida
-
Miami Lakes, Florida, États-Unis, 33014
- The Research Center
-
Oldsmar, Florida, États-Unis, 34677
- Journey Research Inc.
-
Orlando, Florida, États-Unis, 32819
- HMD Research LLC
-
Orlando, Florida, États-Unis, 32806
- Anderson Allergy And Asthma, PA
-
Orlando, Florida, États-Unis, 32825
- AHMG Pulmonology at East Orlando
-
Pembroke Pines, Florida, États-Unis, 33025
- Pines Care Research Center LLC
-
Sweetwater, Florida, États-Unis, 33182
- Cordova Research Institute, LLC
-
Tamarac, Florida, États-Unis, 33321
- TBC Research Corp
-
Tampa, Florida, États-Unis, 33604
- Wecare research center LLC
-
Tampa, Florida, États-Unis, 33607-6327
- Clinical Research Trials of Florida, Inc.
-
Tampa, Florida, États-Unis, 33607
- Nodal Medical Center, Llc
-
Virginia Gardens, Florida, États-Unis, 33166
- Hope Research Network/CBS Laboratory
-
Winter Park, Florida, États-Unis, 32789
- Florida Pediatric Research Institute
-
-
Georgia
-
Atlanta, Georgia, États-Unis, 30329
- Children's Healthcare of Atlanta Center for Advanced Pediatrics
-
Conyers, Georgia, États-Unis, 30012
- Oracle Clinical Research
-
Savannah, Georgia, États-Unis, 31406-2668
- Aeroallergy Research Laboratories of Savannah, Inc.
-
-
Idaho
-
Boise, Idaho, États-Unis, 83706
- Treasure Valley Medical Research
-
-
Illinois
-
Chicago, Illinois, États-Unis, 60612
- Rush University Medical Center
-
Chicago, Illinois, États-Unis, 60637
- University of Chicago
-
Chicago, Illinois, États-Unis, 60607
- Cedar Crosse Research Center
-
Skokie, Illinois, États-Unis, 60077
- Northshore University Health System Clinical Trials Center
-
-
Indiana
-
Evansville, Indiana, États-Unis, 47715
- Deaconess Clinic
-
-
Kansas
-
Overland Park, Kansas, États-Unis, 66210
- Velocity Clinical Research, Kansas City
-
-
Kentucky
-
Lexington, Kentucky, États-Unis, 40509
- Bluegrass Allergy Research
-
-
Louisiana
-
Lafayette, Louisiana, États-Unis, 70508
- Velocity Clinical Research - Lafayette
-
-
Maine
-
Bangor, Maine, États-Unis, 04401
- Paul A. Shapero M.D.
-
-
Maryland
-
Rockville, Maryland, États-Unis, 20852
- DelRicht Research @ Matthew Mintz Clinic
-
White Marsh, Maryland, États-Unis, 21162
- Chesapeake Clinical Research Inc
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02115
- Brigham Womens Hospital
-
Fall River, Massachusetts, États-Unis, 02723
- Exordia Medical Research Inc,
-
North Dartmouth, Massachusetts, États-Unis, 02747
- Infinity Medical Research
-
South Dartmouth, Massachusetts, États-Unis, 02747
- Mayflower Clinical Research
-
-
Michigan
-
Detroit, Michigan, États-Unis, 48202
- Henry Ford
-
Flint, Michigan, États-Unis, 48507
- Onyx Clinical Research
-
Ypsilanti, Michigan, États-Unis, 48197
- Respiratory Medicine Research Institute of Michigan
-
-
Missouri
-
Kansas City, Missouri, États-Unis, 66160
- University of Kansas School of Medicine
-
St Louis, Missouri, États-Unis, 63110
- Washington University
-
St Louis, Missouri, États-Unis, 63123
- Clayton Sleep Institute
-
St Louis, Missouri, États-Unis, 63141-7068
- Midwest Clinical Research
-
-
Nebraska
-
Hastings, Nebraska, États-Unis, 68901
- Family Medical Center of Hastings
-
-
Nevada
-
Las Vegas, Nevada, États-Unis, 89123-2875
- American Institute of Medical Research
-
-
New Jersey
-
North Bergen, New Jersey, États-Unis, 07047
- Northern Valley Allergy, Asthma & Sinus Center
-
-
New York
-
Hawthorne, New York, États-Unis, 10532
- New York Medical College
-
Horseheads, New York, États-Unis, 14845
- Corning Center for Clinical Research
-
Hyde Park, New York, États-Unis, 11042
- Northwell Health Physician Partners
-
New Windsor, New York, États-Unis, 12553
- Mid Hudson Medical Research PLLC
-
-
North Carolina
-
Asheville, North Carolina, États-Unis, 28803
- Allergy Partners of WNC
-
Chapel Hill, North Carolina, États-Unis, 27599
- UNC Chapel Hill
-
Charlotte, North Carolina, États-Unis, 28277
- OnSite Clinical Solutions LLC
-
Elizabeth City, North Carolina, États-Unis, 27909-3465
- Atlantic Pulmonary Associates
-
High Point, North Carolina, États-Unis, 27260
- Peters Medical Research, LLC
-
Statesville, North Carolina, États-Unis, 28625
- Piedmont Healthcare, P.A.
-
Wilmington, North Carolina, États-Unis, 28401
- Accellacare of Wilmington
-
Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest Baptist Health
-
-
Ohio
-
Cincinnati, Ohio, États-Unis, 45236
- Bernstein Clinical Research Center
-
Columbus, Ohio, États-Unis, 43205
- Nationwide Childrens Hospital
-
Dayton, Ohio, États-Unis, 45429
- PriMed Clinical Research
-
Dayton, Ohio, États-Unis, 45404
- Daytons Children's Hospital
-
Toledo, Ohio, États-Unis, 43617
- Toledo Institute of Clinical Research Inc
-
Toledo, Ohio, États-Unis, 43606
- ProMedica Russell J. Ebeid Children's Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, États-Unis, 73120-9389
- Allergy Asthma Clinical Research Cent
-
Tulsa, Oklahoma, États-Unis, 74133
- Pulmonary & Sleep Center of Oklahoma
-
Yukon, Oklahoma, États-Unis, 73099
- Tekton Research
-
-
Oregon
-
Grants Pass, Oregon, États-Unis, 97527
- Velocity Clinical Research, Grants Pass
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19140
- Temple University Hospital
-
Pittsburgh, Pennsylvania, États-Unis, 15241
- Allergy and Clinical Immunology
-
-
South Carolina
-
North Charleston, South Carolina, États-Unis, 29420
- National Allergy and Asthma Research LLC.
-
Rock Hill, South Carolina, États-Unis, 29732
- Clinical Research of Rock Hill
-
-
Tennessee
-
Knoxville, Tennessee, États-Unis, 37909
- Allergy Associates, PA dba Allergy, Asthma & Sinus Center
-
-
Texas
-
Austin, Texas, États-Unis, 78759
- Orion Clinical Research
-
Boerne, Texas, États-Unis, 78006
- South Texas Medical Research Institute, Inc., DBA TTS Research
-
Brownsville, Texas, États-Unis, 78520
- PanAmerican Clinical Research Brownsville
-
Corsicana, Texas, États-Unis, 75110
- Corsicana Medical Research
-
Dallas, Texas, États-Unis, 75235
- Southwest Family Medicine Associates
-
Dallas, Texas, États-Unis, 75209
- Alina Clinical Trials, LLC, Barbara Baxter Sole MBR
-
Dallas, Texas, États-Unis, 75231-8206
- AARA Research Center
-
Edinburg, Texas, États-Unis, 78539
- Proactive Clinical Research LLC
-
El Paso, Texas, États-Unis, 79902
- El Paso Pulmonary Association
-
El Paso, Texas, États-Unis, 79912
- Western Sky Medical Research
-
El Paso, Texas, États-Unis, 79902
- Proactive el Paso, LLC
-
Houston, Texas, États-Unis, 77099
- Pioneer Research Solutions
-
Houston, Texas, États-Unis, 77008
- Trio Clinical Trials
-
Houston, Texas, États-Unis, 77065
- Innovative Medical Research of Texas LLC
-
Houston, Texas, États-Unis, 77030
- Texas Children's Allergy and Immunology, Houston
-
Houston, Texas, États-Unis, 77074-2005
- Clinical Trial Network
-
Katy, Texas, États-Unis, 77494
- R & H Clinical Research
-
Kerrville, Texas, États-Unis, 78028
- Sante Clinical Research LLC
-
McKinney, Texas, États-Unis, 75069
- Metroplex Pulmonary and Sleep Center Drive
-
San Antonio, Texas, États-Unis, 78229
- STAAMP Research, LLC
-
San Antonio, Texas, États-Unis, 78258
- Element Research Group
-
San Antonio, Texas, États-Unis, 78212
- Quality Assurance Research Center
-
Sherman, Texas, États-Unis, 75090
- Sherman Clinical Research
-
Splendora, Texas, États-Unis, 77372
- APD Clinical Research / PCP for Life
-
Tomball, Texas, États-Unis, 77081
- DM Clinical Tomball
-
Victoria, Texas, États-Unis, 77901
- Victoria Clinical Research Group
-
Waxahachie, Texas, États-Unis, 75165-1430
- ClinPoint Trials
-
-
Utah
-
Bountiful, Utah, États-Unis, 84010
- Pantheon Clinical Research
-
Sandy City, Utah, États-Unis, 84093
- Allergy Associates of Utah
-
West Valley City, Utah, États-Unis, 84119
- Chronicle Bio
-
-
Virginia
-
Williamsburg, Virginia, États-Unis, 23188
- Tidewater Physicians Multispecialty Group (TPMG) Clinical Research
-
-
Wisconsin
-
Greenfield, Wisconsin, États-Unis, 53228
- Allergy, Asthma & Sinus Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
4 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Comparateur actif: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Délai jusqu'à la première exacerbation clinique sévère de l'asthme (CAE) avec Fp/ABS eMDPI à dose élevée (HD)
Délai: Jusqu'à 42 mois
|
Jusqu'à 42 mois
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Temps jusqu'au premier événement indésirable grave sévère avec Fp/ABS eMDPI à faible dose (FD)
Délai: Jusqu'à 42 mois
|
Jusqu'à 42 mois
|
|
|
Nombre de participants avec au moins un événement indésirable grave
Délai: Jusqu'à 42 mois
|
Jusqu'à 42 mois
|
|
|
Nombre de participants qui se sont retirés de l'essai en raison d'événements indésirables émergents du traitement
Délai: Jusqu'à 42 mois
|
Jusqu'à 42 mois
|
|
|
Annualized Severe CAE Rate
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Directeur d'études: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 août 2023
Achèvement primaire (Estimé)
31 décembre 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
18 septembre 2023
Première soumission répondant aux critères de contrôle qualité
18 septembre 2023
Première publication (Réel)
25 septembre 2023
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 novembre 2026
Dernière vérification
1 novembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies bronchiques
- Maladies pulmonaires obstructives
- Hypersensibilité respiratoire
- Hypersensibilité immédiate
- Hypersensibilité
- Asthme
- Produits chimiques organiques
- Amines
- Alcools
- Alcools amino
- Éthanolamines
- Phénéthylamines
- Éthylamines
- Albutérol
Autres numéros d'identification d'étude
- FpA-AS-30094
- 2023-505435-12-00 (Identificateur de registre: CTIS (EU))
- 2023 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .