En undersøgelse for at teste, om en fastdosiskombination af fluticasonpropionat/albuterolsulfat er effektiv til at forhindre astma-eksacerbationer
2. november 2026 opdateret af: Teva Branded Pharmaceutical Products R&D LLC
Et randomiseret, dobbeltblindt, multicenter, aktivt kontrolleret, parallelgruppestudie til evaluering af effektiviteten og sikkerheden af fluticasonpropionat/albuterolsulfat-fastdosiskombination på alvorlige astma-eksacerbationer hos patienter med astma
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
Studieoversigt
Status
Status
Aktiv, ikke rekrutterende
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
2769
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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, Australien, 3128
- Eastern Health, Box Hill Hospital
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Clayton, Australien, 3168
- Monash Health
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Melbourne, Australien, 3004
- Alfred Health
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Midland, Australien, 6056
- Institute for Respiratory Health - Midland
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Nedlands, Australien, 6009
- Institute for Respiratory Health ,Sir Charles Gairdner Hospital
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North Adelaide, Australien, 5006
- Women's and Children's Hospital (WCH)
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Parkville, Australien, 3052
- The Royal Children's Hospital Melbourne
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South Brisbane, Australien, 4101
- Centre for Childrens Health Research
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Blagoevgrad, Bulgarien, 2700
- Multiprofile Hospital for Active Treatment Puls AD
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Kozloduy, Bulgarien, 3320
- Medical Center Zdrave 1 - OOD
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Pernik, Bulgarien, 2300
- DCC-1 Pernik
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Pleven, Bulgarien, 5800
- Medical Center MedConsult Pleven OOD
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Plovdiv, Bulgarien, 4002
- UMHAT Sveti Georgi
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Plovdiv, Bulgarien, 4002
- Medical Center Dar Plovdiv OOD
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Rousse, Bulgarien, 7002
- SHATPPD - Ruse Pulmonary Hospital
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Sliven, Bulgarien, 8800
- Diagnostic - Consultative Center - Sliven OOD
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Sofia, Bulgarien, 1407
- Medical Center Excelsior
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Sofia, Bulgarien, 1408
- DCC NeoClinic
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Sofia, Bulgarien, 1142
- First MHAT - Sofia
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Sofia, Bulgarien, 1421
- AGPSMP Pediatric Diseases South Park OOD
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Sofia, Bulgarien, 1431
- DKC Alexandrovska EOOD
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Sofia, Bulgarien, 1680
- Diagnostic - Consultative Center Convex EOOD
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Stara Zagora, Bulgarien, 6001
- Medical Center New Rehabilitation Center Ltd
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Varna, Bulgarien, 9000
- MC Research expert
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Vratsa, Bulgarien, 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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Aalborg, Danmark, 9100
- Aalborg University Hospital
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Hvidovre, Danmark, 2650
- Hvidovre Hospital
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Vejle, Danmark, 7100
- Vejle Hospital
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- The University of Alabama at Birmingham
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Birmingham, Alabama, Forenede Stater, 35209
- AllerVie Clnical Research
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Dothan, Alabama, Forenede Stater, 36305
- SEC Clinical Research
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Arizona
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Paradise Valley, Arizona, Forenede Stater, 85258
- One of a Kind Clinical Research Center LLC
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Scottsdale, Arizona, Forenede Stater, 85259
- Mayo Clinic
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Tucson, Arizona, Forenede Stater, 85741
- Novak Clinical Research
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California
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Bakersfield, California, Forenede Stater, 93301
- Kern Research, Inc
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Fresno, California, Forenede Stater, 93704
- Clinical Research of Central California, LLC
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Huntington Beach, California, Forenede Stater, 92647-6853
- Allergy and Asthma Specialists Medical Group
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La Jolla, California, Forenede Stater, 92037
- Orso Health
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La Palma, California, Forenede Stater, 90623
- IMAX Clinical Trials
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Long Beach, California, Forenede Stater, 90815
- Ark Clinical Research, LLC
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Long Beach, California, Forenede Stater, 90806-2613
- Long Beach Clinical Trials
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Los Angeles, California, Forenede Stater, 90025
- Ricardo Antonio Tan Inc
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Napa, California, Forenede Stater, 94558
- One of a Kind Clinical Research Center LLC
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Northridge, California, Forenede Stater, 91324
- California Medical Research Associates Inc.
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Redondo Beach, California, Forenede Stater, 90277-5720
- Riviera Allergy Medical Center
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San Bernardino, California, Forenede Stater, 92408
- Velocity Clinical Research, Banning
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San Diego, California, Forenede Stater, 92120
- Institute of HealthCare Assessment, Inc
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San Jose, California, Forenede Stater, 95117
- Allergy and Asthma Associates
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Stockton, California, Forenede Stater, 95207
- Bensch Clinical Research LLC
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Westminster, California, Forenede Stater, 92683
- Allianz Research Institute
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Colorado
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Aurora, Colorado, Forenede Stater, 80014
- Allianz Research Institute
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Colorado Springs, Colorado, Forenede Stater, 80907
- CRN Clinical Research Network LLC/Asthma and Allergy Associates P.C.
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Colorado Springs, Colorado, Forenede Stater, 80922
- OptumCare Colorado Springs LLC
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Englewood, Colorado, Forenede Stater, 80110
- Velocity Clinical Research
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20009
- Emerson Clinical Research Institute
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Florida
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Aventura, Florida, Forenede Stater, 33180
- Florida Center for Allergy and Asthma Research
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Cape Coral, Florida, Forenede Stater, 33914
- Renaissance Research and Medical Group
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Cutler Bay, Florida, Forenede Stater, 33189
- Cenara Clinical Research
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Doral, Florida, Forenede Stater, 33122
- D & H Doral Research Centers
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Greenacres City, Florida, Forenede Stater, 33476
- Finlay Medical Research Corp
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Hialeah, Florida, Forenede Stater, 33012
- Direct Helpers Research Center, Inc.
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Hialeah, Florida, Forenede Stater, 33012
- New Life Research Institute, LLC
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Homestead, Florida, Forenede Stater, 33030
- Homestead Medical Research
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Jacksonville, Florida, Forenede Stater, 32207
- Nemours Children Clinic
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Leesburg, Florida, Forenede Stater, 34748
- Clinical Site Partner, LLC DBA Flourish Research
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Margate, Florida, Forenede Stater, 33063
- D & H Pompano Research Centers, Inc.
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Miami, Florida, Forenede Stater, 33126
- Finlay Medical Research
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Miami, Florida, Forenede Stater, 33144
- Bio-Medical Research LLC
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Miami, Florida, Forenede Stater, 33186
- Phoenix Research Center, LLC
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Miami, Florida, Forenede Stater, 33173
- Century Research LLC
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Miami, Florida, Forenede Stater, 33155
- D & H National Research Centers, Inc.
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Miami, Florida, Forenede Stater, 33143
- Florida Pharmaceutical Research and Associates
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Miami, Florida, Forenede Stater, 33126
- EMDA Clinical Research
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Miami, Florida, Forenede Stater, 33126
- Life Arc Research Centers
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Miami, Florida, Forenede Stater, 33130
- Care Research Center
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Miami, Florida, Forenede Stater, 33142-2946
- Acevedo Clinical Research Associates
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Miami, Florida, Forenede Stater, 33144
- Y&L Advance Health Care, Inc. d/b/a Elite Clinical Research
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Miami, Florida, Forenede Stater, 33173
- Advance Medical Research Practice
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Miami, Florida, Forenede Stater, 33173
- Florida Center for Allergy and Asthma Research
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Miami, Florida, Forenede Stater, 33175
- ITB Research
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Miami, Florida, Forenede Stater, 33176
- DY Professional Research Center
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Miami, Florida, Forenede Stater, 33176
- IMIC INC
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Miami Lakes, Florida, Forenede Stater, 33014
- San Marcus Research Clinic, Inc.
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Miami Lakes, Florida, Forenede Stater, 33016
- Quality Research of South Florida
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Miami Lakes, Florida, Forenede Stater, 33014
- The Research Center
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Oldsmar, Florida, Forenede Stater, 34677
- Journey Research Inc.
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Orlando, Florida, Forenede Stater, 32819
- HMD Research LLC
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Orlando, Florida, Forenede Stater, 32806
- Anderson Allergy And Asthma, PA
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Orlando, Florida, Forenede Stater, 32825
- AHMG Pulmonology at East Orlando
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Pembroke Pines, Florida, Forenede Stater, 33025
- Pines Care Research Center LLC
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Sweetwater, Florida, Forenede Stater, 33182
- Cordova Research Institute, LLC
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Tamarac, Florida, Forenede Stater, 33321
- TBC Research Corp
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Tampa, Florida, Forenede Stater, 33604
- Wecare research center LLC
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Tampa, Florida, Forenede Stater, 33607-6327
- Clinical Research Trials of Florida, Inc.
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Tampa, Florida, Forenede Stater, 33607
- Nodal Medical Center, Llc
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Virginia Gardens, Florida, Forenede Stater, 33166
- Hope Research Network/CBS Laboratory
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Winter Park, Florida, Forenede Stater, 32789
- Florida Pediatric Research Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30329
- Children's Healthcare of Atlanta Center for Advanced Pediatrics
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Conyers, Georgia, Forenede Stater, 30012
- Oracle Clinical Research
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Savannah, Georgia, Forenede Stater, 31406-2668
- Aeroallergy Research Laboratories of Savannah, Inc.
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Idaho
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Boise, Idaho, Forenede Stater, 83706
- Treasure Valley Medical Research
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
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Chicago, Illinois, Forenede Stater, 60607
- Cedar Crosse Research Center
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Skokie, Illinois, Forenede Stater, 60077
- Northshore University Health System Clinical Trials Center
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Indiana
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Evansville, Indiana, Forenede Stater, 47715
- Deaconess Clinic
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Kansas
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Overland Park, Kansas, Forenede Stater, 66210
- Velocity Clinical Research, Kansas City
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40509
- Bluegrass Allergy Research
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Louisiana
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Lafayette, Louisiana, Forenede Stater, 70508
- Velocity Clinical Research - Lafayette
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Paul A. Shapero M.D.
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Maryland
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Rockville, Maryland, Forenede Stater, 20852
- DelRicht Research @ Matthew Mintz Clinic
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White Marsh, Maryland, Forenede Stater, 21162
- Chesapeake Clinical Research Inc
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Brigham Womens Hospital
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Fall River, Massachusetts, Forenede Stater, 02723
- Exordia Medical Research Inc,
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North Dartmouth, Massachusetts, Forenede Stater, 02747
- Infinity Medical Research
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South Dartmouth, Massachusetts, Forenede Stater, 02747
- Mayflower Clinical Research
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford
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Flint, Michigan, Forenede Stater, 48507
- Onyx Clinical Research
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Ypsilanti, Michigan, Forenede Stater, 48197
- Respiratory Medicine Research Institute of Michigan
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Missouri
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Kansas City, Missouri, Forenede Stater, 66160
- University of Kansas School of Medicine
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St Louis, Missouri, Forenede Stater, 63110
- Washington University
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St Louis, Missouri, Forenede Stater, 63123
- Clayton Sleep Institute
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St Louis, Missouri, Forenede Stater, 63141-7068
- Midwest Clinical Research
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Nebraska
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Hastings, Nebraska, Forenede Stater, 68901
- Family Medical Center of Hastings
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89123-2875
- American Institute of Medical Research
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New Jersey
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North Bergen, New Jersey, Forenede Stater, 07047
- Northern Valley Allergy, Asthma & Sinus Center
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New York
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Hawthorne, New York, Forenede Stater, 10532
- New York Medical College
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Horseheads, New York, Forenede Stater, 14845
- Corning Center for Clinical Research
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Hyde Park, New York, Forenede Stater, 11042
- Northwell Health Physician Partners
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New Windsor, New York, Forenede Stater, 12553
- Mid Hudson Medical Research PLLC
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28803
- Allergy Partners of WNC
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Chapel Hill, North Carolina, Forenede Stater, 27599
- UNC Chapel Hill
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Charlotte, North Carolina, Forenede Stater, 28277
- OnSite Clinical Solutions LLC
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Elizabeth City, North Carolina, Forenede Stater, 27909-3465
- Atlantic Pulmonary Associates
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High Point, North Carolina, Forenede Stater, 27260
- Peters Medical Research, LLC
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Statesville, North Carolina, Forenede Stater, 28625
- Piedmont Healthcare, P.A.
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Wilmington, North Carolina, Forenede Stater, 28401
- Accellacare of Wilmington
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest Baptist Health
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45236
- Bernstein Clinical Research Center
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Columbus, Ohio, Forenede Stater, 43205
- Nationwide Childrens Hospital
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Dayton, Ohio, Forenede Stater, 45429
- PriMed Clinical Research
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Dayton, Ohio, Forenede Stater, 45404
- Daytons Children's Hospital
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Toledo, Ohio, Forenede Stater, 43617
- Toledo Institute of Clinical Research Inc
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Toledo, Ohio, Forenede Stater, 43606
- ProMedica Russell J. Ebeid Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73120-9389
- Allergy Asthma Clinical Research Cent
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Tulsa, Oklahoma, Forenede Stater, 74133
- Pulmonary & Sleep Center of Oklahoma
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Yukon, Oklahoma, Forenede Stater, 73099
- Tekton Research
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Oregon
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Grants Pass, Oregon, Forenede Stater, 97527
- Velocity Clinical Research, Grants Pass
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19140
- Temple University Hospital
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Pittsburgh, Pennsylvania, Forenede Stater, 15241
- Allergy and Clinical Immunology
-
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South Carolina
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North Charleston, South Carolina, Forenede Stater, 29420
- National Allergy and Asthma Research LLC.
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Rock Hill, South Carolina, Forenede Stater, 29732
- Clinical Research of Rock Hill
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37909
- Allergy Associates, PA dba Allergy, Asthma & Sinus Center
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Texas
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Austin, Texas, Forenede Stater, 78759
- Orion Clinical Research
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Boerne, Texas, Forenede Stater, 78006
- South Texas Medical Research Institute, Inc., DBA TTS Research
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Brownsville, Texas, Forenede Stater, 78520
- PanAmerican Clinical Research Brownsville
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Corsicana, Texas, Forenede Stater, 75110
- Corsicana Medical Research
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Dallas, Texas, Forenede Stater, 75235
- Southwest Family Medicine Associates
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Dallas, Texas, Forenede Stater, 75209
- Alina Clinical Trials, LLC, Barbara Baxter Sole MBR
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Dallas, Texas, Forenede Stater, 75231-8206
- AARA Research Center
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Edinburg, Texas, Forenede Stater, 78539
- Proactive Clinical Research LLC
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El Paso, Texas, Forenede Stater, 79902
- El Paso Pulmonary Association
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El Paso, Texas, Forenede Stater, 79912
- Western Sky Medical Research
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El Paso, Texas, Forenede Stater, 79902
- Proactive el Paso, LLC
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Houston, Texas, Forenede Stater, 77099
- Pioneer Research Solutions
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Houston, Texas, Forenede Stater, 77008
- Trio Clinical Trials
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Houston, Texas, Forenede Stater, 77065
- Innovative Medical Research of Texas LLC
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Houston, Texas, Forenede Stater, 77030
- Texas Children's Allergy and Immunology, Houston
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Houston, Texas, Forenede Stater, 77074-2005
- Clinical Trial Network
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Katy, Texas, Forenede Stater, 77494
- R & H Clinical Research
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Kerrville, Texas, Forenede Stater, 78028
- Sante Clinical Research LLC
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McKinney, Texas, Forenede Stater, 75069
- Metroplex Pulmonary and Sleep Center Drive
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San Antonio, Texas, Forenede Stater, 78229
- STAAMP Research, LLC
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San Antonio, Texas, Forenede Stater, 78258
- Element Research Group
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San Antonio, Texas, Forenede Stater, 78212
- Quality Assurance Research Center
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Sherman, Texas, Forenede Stater, 75090
- Sherman Clinical Research
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Splendora, Texas, Forenede Stater, 77372
- APD Clinical Research / PCP for Life
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Tomball, Texas, Forenede Stater, 77081
- DM Clinical Tomball
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Victoria, Texas, Forenede Stater, 77901
- Victoria Clinical Research Group
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Waxahachie, Texas, Forenede Stater, 75165-1430
- ClinPoint Trials
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Utah
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Bountiful, Utah, Forenede Stater, 84010
- Pantheon Clinical Research
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Sandy City, Utah, Forenede Stater, 84093
- Allergy Associates of Utah
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West Valley City, Utah, Forenede Stater, 84119
- Chronicle Bio
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Virginia
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Williamsburg, Virginia, Forenede Stater, 23188
- Tidewater Physicians Multispecialty Group (TPMG) Clinical Research
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Wisconsin
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Greenfield, Wisconsin, Forenede Stater, 53228
- Allergy, Asthma & Sinus Center
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-
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Alexandroupoli, Grækenland, 68100
- University General Hospital of Alexandroupolis
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Athens, Grækenland, 10675
- Evaggelismos General Hospital
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Athens, Grækenland, 11527
- General Pediatric Hospital Panayioti ans Aglaias Kyriakou
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Heraklion, Grækenland, 71500
- University General Hospital of Heraklion
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Larissa, Grækenland, 41 110
- University General Hospital of Larissa
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Thessaloniki, Grækenland, 54639
- Pulmonary Clinic - Athens Medical Center SA, Interbalkan Medical Center of Thessaloniki
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Thessaloniki, Grækenland, 57 010
- General Hospital of 'Thessaloniki G. Papanikolaou'
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Ashkelon, Israel, 7830604
- Barzilai Medical Center
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Beersheba, Israel, 8457108
- Soroka University Medical Center
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Haifa, Israel, 3109601
- Rambam Health Care Campus - The Ruth Rappaport Children's Hospital
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center - Pulmonary Institute
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Jerusalem, Israel, 9112010
- The Hadassah University Hospital-Ein Kerem - Institute of Pulmonology
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Petach Tikvah, Israel, 4920235
- Kipper Institute of Allergy and Immunology at Schneider Children's Medical Center of Israel
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Petah Tikva, Israel, 4941492
- Rabin Medical Center
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Rehovot, Israel, 7661041
- Kaplan Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center - Ichilov
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-
-
-
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Ferrara, Italien, 44124
- AOU Ferrara - Arcispedale S.Anna
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Padova, Italien, 35128
- Azienda Ospedale - Universita Padova
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Pisa, Italien, 56126
- Azienda Ospedaliero Universitaria Pisana
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Verona, Italien, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
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Verona, Italien, 37131
- Azienda Ospedaliera Universitaria Integrata Verona (AOUI)
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-
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-
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Balvi, Letland, LV-4501
- Balvu and Gulbenes Hospital Association
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Daugavpils, Letland, LV-5417
- Daugavpils Regional Hospital, Centre of Lung Diseases and Tuberculosis
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Jūrmala, Letland, LV-2015
- Health Center Association, Clinic Dubulti
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Riga, Letland, LV-1003
- The Centre of Investigation and Treatment of Allergic Diseases
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Riga, Letland, 1004
- LOR Clinic
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Riga, Letland, LV-1004
- Bernu KUS
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Riga, Letland, LV1010
- Consilium Medical
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Rēzekne, Letland, 4601
- Vevere Viktorija - Doctor's Practice in Pneumology and Allergology
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Chihuahua City, Mexico, 31203
- Mediadvance Clinical
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Guadalajara, Mexico, 44670
- PanAmerican Clinical Research - Guadalajara
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Guadalajara, Mexico, 44100
- Instituto Jaliscience de Investigacion Clinica
-
Monterrey, Mexico, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzl
-
Oaxaca City, Mexico, 68000
- Oaxaca Site Management Organization S.C. (OSMO) - Investigacion Clinica
-
Villahermosa, Mexico, 86035
- Consultorio De Especialidad Alergologia Pediatrica
-
-
-
-
-
Auckland, New Zealand, 1010
- Optimal Clinical Trials Ltd
-
Auckland, New Zealand, 626
- Optimal Clinical Trials - North
-
Christchurch, New Zealand, 8013
- PCRN Forte
-
Dunedin, New Zealand, 9016
- Momentum Dunedin
-
Hamilton, New Zealand, 3204
- Waikato Hospital
-
Hamilton, New Zealand, 3200
- Lakeland Clinical Trials Waikato
-
Hastings, New Zealand, 4122
- P3 Research Ltd
-
Nelson, New Zealand, 7011
- PCRN - Tasman
-
Rotorua, New Zealand, 3010
- PCRN Rotorua
-
Tauranga, New Zealand, 3110
- Clinical Horizons New Zealand Limited
-
Waikanae Beach, New Zealand, 5036
- P3 Research Kapiti
-
Wellington, New Zealand, 6021
- MRINZ
-
-
-
-
-
Bialystok, Polen, 15-010
- Prywatny Gabinet Internistyczno - Alergologiczny
-
Bialystok, Polen, 15-430
- Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
-
Bydgoszcz, Polen, 85-796
- Centrum Medyczne Pratia Bydgoszcz
-
Elblag, Polen, 82-300
- Centrum Badan Klinicznych Agnieszka Mital
-
Gdansk, Polen, 80-214
- University Clinical Center Medical University of Gdansk
-
Gdansk, Polen, 80-344
- Clinica Vitae Sp. z o.o.
-
Krakow, Polen, 31-624
- Malopolskie Centrum Alergologii
-
Krakow, Polen, 31-141
- Nzoz Atopia
-
Lodz, Polen, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
Lublin, Polen, 20-089
- Przychodnia Alergopneuma
-
Lublin, Polen, 20-095
- Alergotest s.c. Specjalistyczne Centrum Medyczne
-
Maków Podhalański, Polen, 34-220
- Makowskie Centrum Medyczne Hamernia Sp z oo
-
Ostrowiec Świętokrzyski, Polen, 27-400
- Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
-
Poznan, Polen, 60-693
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus
-
Rzeszów, Polen, 35-051
- Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
-
Skierniewice, Polen, 96-100
- Velocity Skierniewice spolka z ograniczona odpowiedzialnoscia
-
Warsaw, Polen, 00-632
- Centrum Zdrowia MDM
-
Zawadzkie, Polen, 47-120
- Centrum Medyczne Lucyna Andrzej Dymek S.C.
-
-
-
-
-
Bacau, Rumænien, 600625
- Spital Pneumoftiziologi Bacau
-
Bragadiru, Rumænien, 769764
- Angisan Grup srl
-
Bucharest, Rumænien, 12052
- Quantum Medical Center
-
Bucharest, Rumænien, 41507
- Marius Nasta Pneumoftiziology Institute
-
Cluj-Napoca, Rumænien, 400371
- Spitalul Clinic de Pneumoftiziologie Leon Daniello
-
Craiova, Rumænien, 200515
- Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes
-
-
-
-
-
Belgrade, Serbien, 11080
- Clinical Hospital Center Zemun
-
Belgrade, Serbien, 11070
- Mother and Child Health Institute of Serbia
-
Belgrade, Serbien, 11000
- Cinic for pulmonary diseases, clinical center of Serbia
-
Belgrade, Serbien, 11000
- Municipal Institute for Lung Diseases and Tuberculosis
-
Belgrade, Serbien, 11000
- Univezitetska Decja Klinika Beograd (University Children's Hospital Belgrade)
-
Kamenitz, Serbien, 21204
- Institut za plucne bolesti Vojvodine
-
Kragujevac, Serbien, 34000
- Clinic for Pulmonology, University Clinical Center Kragujevac
-
Niš, Serbien, 18000
- Clinical Centre of Nis,Clinic for Lung Diseases
-
Novi Sad, Serbien, 21000
- Institute for Child and Youth Health Care
-
-
-
-
-
Bardejov, Slovakiet, 08501
- Ns PSv. Jakuba
-
Kežmarok, Slovakiet, 06224
- AlergoImuno centrum s.r.o. - Ambulancia alergologi
-
Košice, Slovakiet, 040 11
- Paediatric University Hospital
-
Rimavská Sobota, Slovakiet, 979 01
- Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie
-
Spišská Nová Ves, Slovakiet, 052 01
- Plucna ambulancia Hrebenar, s.r.o.
-
Žilina, Slovakiet, 01001
- Emin s.r.o.
-
Žilina, Slovakiet, 1001
- Alergologicka a imunologicka ambulancia
-
-
-
-
-
Badalona, Spanien, 8916
- Hospital Universitari Germans Trias I Pujol
-
Barcelona, Spanien, 08017
- Pectus Respiratory Health (Giromed Institute)
-
Barcelona, Spanien, 08035
- Hospital Materno Infantil, Planta 13
-
Córdoba, Spanien, 14004
- Hopital Quironsalud Cordoba
-
Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Maranon
-
Sabadell, Spanien, 8208
- Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
-
Santiago de Compostela, Spanien, 15706
- Hospital Clinico Universitario de Santiago
-
Seville, Spanien, 41013
- Hospital Universitario Virgen del Rocio
-
Valencia, Spanien, 46015
- Hospital Arnau de Vilanova
-
-
-
-
-
Benoni, Sydafrika, 1501
- Worthwhile Clinical Trials
-
Cape Town, Sydafrika, 7530
- TASK Applied Science
-
Cape Town, Sydafrika, 7700
- University of Cape Town Lung Institute
-
Cape Town, Sydafrika, 7530
- Tiervlei Trial Centre
-
Cape Town, Sydafrika, 7570
- Langeberg Clinical Trials (*Medicross)
-
Centurion, Sydafrika, 0157
- Global Clinical Trials
-
Chatsworth, Sydafrika, 4092
- Precise Clinical Solutions
-
Durban, Sydafrika, 4092
- Dr PJ Sebastian
-
Ennerdale, Sydafrika, 1830
- Reimed Ennerdale
-
Germiston, Sydafrika, 1401
- CRISMO Bertha Gxowa Research Centre
-
Johannesburg, Sydafrika, 2113
- Newtown Clinical Research Centre
-
Krugersdorp, Sydafrika, 1739
- Ubuntu Clinical Research
-
KwaDukuza, Sydafrika, 4450
- Office of Jeevren Reddy MBChB
-
Middelburg, Sydafrika, 1050
- Merclinico
-
Midrand, Sydafrika, 1685
- Midrand Medical Centre
-
Plettenberg Bay, Sydafrika, 6600
- Tsitsikamma Clinical Research Initiative Unit 6,
-
Polokwane, Sydafrika, 699
- Gole Biomed Research Centre
-
Pretoria, Sydafrika, 0181
- Into Research
-
Roodepoort, Sydafrika, 1724
- Roodepoort Medicross Clinical Research Centre
-
Somerset West, Sydafrika, 7130
- Helderberg Clinical Research Centre - Somerset West
-
Soweto, Sydafrika, 1868
- Bheki Mlangeni District Hospital
-
-
-
-
-
Seoul, Sydkorea, 5505
- Asan Medical Center
-
Seoul, Sydkorea, 04763
- Hanyang University Seoul Hospital
-
Seoul, Sydkorea, 6591
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul, Sydkorea, 3722
- Yonsei University Health System - Severance Hospital
-
Seoul, Sydkorea, 1757
- Inje University Sanggye Paik Hospital
-
Seoul, Sydkorea, 3312
- The Catholic University of Korea - Eunpyeong St. Marys Hospital
-
-
-
-
-
Brandýs nad Labem-Stará Boleslav, Tjekkiet, 25001
- MUDr. I. Cierna-Peterova s.r.o.
-
Brno, Tjekkiet, 60200
- Fakultni Nemocnice u Sv. Anny - FNUSA
-
Jihlava, Tjekkiet, 586 01
- Alergologie a imunologie MUDr. Hofstetr
-
Jindřichův Hradec, Tjekkiet, 37701
- MediTrial s.r.o.
-
Lovosice, Tjekkiet, 410 02
- CEFISPIRO s.r.o.
-
Ostrava, Tjekkiet, 70900
- Alergologie SKOPKOVA s.r.o.
-
Prague, Tjekkiet, 148 00
- Dawon s.r.o MU
-
Varnsdorf, Tjekkiet, 40747
- PNEUMOLOGIE VARNSDORF s.r.o.
-
-
-
-
-
Augsburg, Tyskland, 86150
- Zentrum fur Pneumologie und Onkologie am Diako
-
Berlin, Tyskland, 10119
- Studienpraxis Berlin-Brandenburg
-
Berlin, Tyskland, 10717
- Research Center for Medical Studies RCMS
-
Berlin, Tyskland, 12159
- Institut fur Allergie-und Asthmaforschung Berlin
-
Cottbus, Tyskland, D-03050
- MECS Cottbus GmbH
-
Darmstadt, Tyskland, 65283
- Pneumostudien Darmstadt GmbH
-
Delitzsch, Tyskland, 4509
- Klifeck GmbH
-
Essen, Tyskland, 45239
- Universitaetsmedizin Essen, Ruhrlandklinik
-
Frankfurt, Tyskland, 60596
- IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
-
Frankfurt am Main, Tyskland, 60596
- Medaimun GmbH
-
Hamburg, Tyskland, 20354
- Pneumologicum Hamburg
-
Hamburg, Tyskland, 22299
- ME Clinical Respiratory Research Hamburg Gmbh
-
Hamburg, Tyskland, 22335
- Praxis Dr. Groth
-
Hanover, Tyskland, 30449
- Siteworks GmbH
-
Ibbenbueren, Tyskland, 49477
- Gemeinschaftspraxis fur Pneumologie Allergologie und Schlafmedizin
-
Karlsruhe, Tyskland, D-76137
- Zentrum fuer klinische Studien Karlsruhe
-
Leipzig, Tyskland, 04347
- POIS Sachsen GmbH
-
Leipzig, Tyskland, 4299
- BAG Prof. G. Hoheisel/Dr. A. Bonitz Praxis fur Pneumologie und Allergologie -Studienzentrum
-
Mainz, Tyskland, 55128
- IKF Pneumologie Mainz
-
München, Tyskland, 80539
- Pneumologie Odeonsplatz Dr. med. Jan Feimer
-
München, Tyskland, 81241
- Pneumologisches Studienzentrum Munchen-West
-
Neu-Isenburg, Tyskland, 63623
- Ballenberger, Freytag, Wenisch ? Institut fur klinische Forschung GmbH
-
Neuss, Tyskland, 41469
- Office of Juergen Funck, Dr.med.
-
Peine, Tyskland, 31224
- Studienzentrum Dr.Schlenska
-
Wiesbaden, Tyskland, 65189
- Velocity Clinical Research Wiesbaden
-
Witten, Tyskland, 58452
- Lungenpraxis Witten
-
-
-
-
-
Budapest, Ungarn, 1033
- Clinexpert Kft
-
Budapest, Ungarn, 1094
- Semmelweis University
-
Budapest, Ungarn, 1027
- High Tech Medical Kft
-
Debrecen, Ungarn, 4027
- Orvostudomanyi Kutato es Fejleszto Kft.
-
Mosonmagyaróvár, Ungarn, 9200
- Omnimodus Elixir KFT.
-
Pécs, Ungarn, 7635
- Infer-Med Kft.
-
Szeged, Ungarn, 6720
- Aranyklinika
-
Szigetvár, Ungarn, 7900
- Spiroped Szigetvar Kft.
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
4 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
3
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
|
Aktiv komparator: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Tid til første svær klinisk astmaforværring (CAE) med høj dosis (HD) Fp/ABS eMDPI
Tidsramme: Op til 42 måneder
|
Op til 42 måneder
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid til første alvorlig CAE med Lav Dosis (LD) Fp/ABS eMDPI
Tidsramme: Op til 42 måneder
|
Op til 42 måneder
|
|
|
Antal deltagere med mindst én alvorlig bivirkning
Tidsramme: Op til 42 måneder
|
Op til 42 måneder
|
|
|
Antal deltagere, der trak sig fra forsøget på grund af behandlingsrelaterede bivirkninger
Tidsramme: Op til 42 måneder
|
Op til 42 måneder
|
|
|
Annualized Severe CAE Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
30. august 2023
Primær færdiggørelse (Anslået)
Primær færdiggørelse
31. december 2026
Studieafslutning (Anslået)
Studieafslutning
31. december 2026
Datoer for studieregistrering
Først indsendt
Først indsendt
18. september 2023
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
18. september 2023
Først opslået (Faktiske)
Først opslået
25. september 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
4. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- FpA-AS-30094
- 2023-505435-12-00 (Registry Identifier: CTIS (EU))
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .