En studie för att testa om en kombination av fast dos av flutikasonpropionat/albuterolsulfat är effektiv för att förebygga astmaexacerbationer
2 november 2026 uppdaterad av: Teva Branded Pharmaceutical Products R&D LLC
En randomiserad, dubbelblind, multicenter, aktivt kontrollerad, parallellgruppsstudie för att utvärdera effektiviteten och säkerheten av flutikasonpropionat/albuterolsulfatkombination med fast dos på allvarliga astmaexacerbationer 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
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
2769
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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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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, Förenta staterna, 35233
- The University of Alabama at Birmingham
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Birmingham, Alabama, Förenta staterna, 35209
- AllerVie Clnical Research
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Dothan, Alabama, Förenta staterna, 36305
- SEC Clinical Research
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Arizona
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Paradise Valley, Arizona, Förenta staterna, 85258
- One of a Kind Clinical Research Center LLC
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Scottsdale, Arizona, Förenta staterna, 85259
- Mayo Clinic
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Tucson, Arizona, Förenta staterna, 85741
- Novak Clinical Research
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California
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Bakersfield, California, Förenta staterna, 93301
- Kern Research, Inc
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Fresno, California, Förenta staterna, 93704
- Clinical Research of Central California, LLC
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Huntington Beach, California, Förenta staterna, 92647-6853
- Allergy and Asthma Specialists Medical Group
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La Jolla, California, Förenta staterna, 92037
- Orso Health
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La Palma, California, Förenta staterna, 90623
- IMAX Clinical Trials
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Long Beach, California, Förenta staterna, 90815
- Ark Clinical Research, LLC
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Long Beach, California, Förenta staterna, 90806-2613
- Long Beach Clinical Trials
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Los Angeles, California, Förenta staterna, 90025
- Ricardo Antonio Tan Inc
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Napa, California, Förenta staterna, 94558
- One of a Kind Clinical Research Center LLC
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Northridge, California, Förenta staterna, 91324
- California Medical Research Associates Inc.
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Redondo Beach, California, Förenta staterna, 90277-5720
- Riviera Allergy Medical Center
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San Bernardino, California, Förenta staterna, 92408
- Velocity Clinical Research, Banning
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San Diego, California, Förenta staterna, 92120
- Institute of HealthCare Assessment, Inc
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San Jose, California, Förenta staterna, 95117
- Allergy and Asthma Associates
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Stockton, California, Förenta staterna, 95207
- Bensch Clinical Research LLC
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Westminster, California, Förenta staterna, 92683
- Allianz Research Institute
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Colorado
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Aurora, Colorado, Förenta staterna, 80014
- Allianz Research Institute
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Colorado Springs, Colorado, Förenta staterna, 80907
- CRN Clinical Research Network LLC/Asthma and Allergy Associates P.C.
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Colorado Springs, Colorado, Förenta staterna, 80922
- OptumCare Colorado Springs LLC
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Englewood, Colorado, Förenta staterna, 80110
- Velocity Clinical Research
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20009
- Emerson Clinical Research Institute
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Florida
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Aventura, Florida, Förenta staterna, 33180
- Florida Center for Allergy and Asthma Research
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Cape Coral, Florida, Förenta staterna, 33914
- Renaissance Research and Medical Group
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Cutler Bay, Florida, Förenta staterna, 33189
- Cenara Clinical Research
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Doral, Florida, Förenta staterna, 33122
- D & H Doral Research Centers
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Greenacres City, Florida, Förenta staterna, 33476
- Finlay Medical Research Corp
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Hialeah, Florida, Förenta staterna, 33012
- Direct Helpers Research Center, Inc.
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Hialeah, Florida, Förenta staterna, 33012
- New Life Research Institute, LLC
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Homestead, Florida, Förenta staterna, 33030
- Homestead Medical Research
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Jacksonville, Florida, Förenta staterna, 32207
- Nemours Children Clinic
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Leesburg, Florida, Förenta staterna, 34748
- Clinical Site Partner, LLC DBA Flourish Research
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Margate, Florida, Förenta staterna, 33063
- D & H Pompano Research Centers, Inc.
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Miami, Florida, Förenta staterna, 33126
- Finlay Medical Research
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Miami, Florida, Förenta staterna, 33144
- Bio-Medical Research LLC
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Miami, Florida, Förenta staterna, 33186
- Phoenix Research Center, LLC
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Miami, Florida, Förenta staterna, 33173
- Century Research LLC
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Miami, Florida, Förenta staterna, 33155
- D & H National Research Centers, Inc.
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Miami, Florida, Förenta staterna, 33143
- Florida Pharmaceutical Research and Associates
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Miami, Florida, Förenta staterna, 33126
- EMDA Clinical Research
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Miami, Florida, Förenta staterna, 33126
- Life Arc Research Centers
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Miami, Florida, Förenta staterna, 33130
- Care Research Center
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Miami, Florida, Förenta staterna, 33142-2946
- Acevedo Clinical Research Associates
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Miami, Florida, Förenta staterna, 33144
- Y&L Advance Health Care, Inc. d/b/a Elite Clinical Research
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Miami, Florida, Förenta staterna, 33173
- Advance Medical Research Practice
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Miami, Florida, Förenta staterna, 33173
- Florida Center for Allergy and Asthma Research
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Miami, Florida, Förenta staterna, 33175
- ITB Research
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Miami, Florida, Förenta staterna, 33176
- DY Professional Research Center
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Miami, Florida, Förenta staterna, 33176
- IMIC INC
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Miami Lakes, Florida, Förenta staterna, 33014
- San Marcus Research Clinic, Inc.
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Miami Lakes, Florida, Förenta staterna, 33016
- Quality Research of South Florida
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Miami Lakes, Florida, Förenta staterna, 33014
- The Research Center
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Oldsmar, Florida, Förenta staterna, 34677
- Journey Research Inc.
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Orlando, Florida, Förenta staterna, 32819
- HMD Research LLC
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Orlando, Florida, Förenta staterna, 32806
- Anderson Allergy And Asthma, PA
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Orlando, Florida, Förenta staterna, 32825
- AHMG Pulmonology at East Orlando
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Pembroke Pines, Florida, Förenta staterna, 33025
- Pines Care Research Center LLC
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Sweetwater, Florida, Förenta staterna, 33182
- Cordova Research Institute, LLC
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Tamarac, Florida, Förenta staterna, 33321
- TBC Research Corp
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Tampa, Florida, Förenta staterna, 33604
- Wecare research center LLC
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Tampa, Florida, Förenta staterna, 33607-6327
- Clinical Research Trials of Florida, Inc.
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Tampa, Florida, Förenta staterna, 33607
- Nodal Medical Center, Llc
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Virginia Gardens, Florida, Förenta staterna, 33166
- Hope Research Network/CBS Laboratory
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Winter Park, Florida, Förenta staterna, 32789
- Florida Pediatric Research Institute
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Georgia
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Atlanta, Georgia, Förenta staterna, 30329
- Children's Healthcare of Atlanta Center for Advanced Pediatrics
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Conyers, Georgia, Förenta staterna, 30012
- Oracle Clinical Research
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Savannah, Georgia, Förenta staterna, 31406-2668
- Aeroallergy Research Laboratories of Savannah, Inc.
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Idaho
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Boise, Idaho, Förenta staterna, 83706
- Treasure Valley Medical Research
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Rush University Medical Center
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Chicago, Illinois, Förenta staterna, 60637
- University of Chicago
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Chicago, Illinois, Förenta staterna, 60607
- Cedar Crosse Research Center
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Skokie, Illinois, Förenta staterna, 60077
- Northshore University Health System Clinical Trials Center
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Indiana
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Evansville, Indiana, Förenta staterna, 47715
- Deaconess Clinic
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Kansas
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Overland Park, Kansas, Förenta staterna, 66210
- Velocity Clinical Research, Kansas City
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40509
- Bluegrass Allergy Research
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Louisiana
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Lafayette, Louisiana, Förenta staterna, 70508
- Velocity Clinical Research - Lafayette
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Maine
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Bangor, Maine, Förenta staterna, 04401
- Paul A. Shapero M.D.
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Maryland
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Rockville, Maryland, Förenta staterna, 20852
- DelRicht Research @ Matthew Mintz Clinic
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White Marsh, Maryland, Förenta staterna, 21162
- Chesapeake Clinical Research Inc
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Brigham Womens Hospital
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Fall River, Massachusetts, Förenta staterna, 02723
- Exordia Medical Research Inc,
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North Dartmouth, Massachusetts, Förenta staterna, 02747
- Infinity Medical Research
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South Dartmouth, Massachusetts, Förenta staterna, 02747
- Mayflower Clinical Research
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford
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Flint, Michigan, Förenta staterna, 48507
- Onyx Clinical Research
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Ypsilanti, Michigan, Förenta staterna, 48197
- Respiratory Medicine Research Institute of Michigan
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Missouri
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Kansas City, Missouri, Förenta staterna, 66160
- University of Kansas School of Medicine
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St Louis, Missouri, Förenta staterna, 63110
- Washington University
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St Louis, Missouri, Förenta staterna, 63123
- Clayton Sleep Institute
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St Louis, Missouri, Förenta staterna, 63141-7068
- Midwest Clinical Research
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Nebraska
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Hastings, Nebraska, Förenta staterna, 68901
- Family Medical Center of Hastings
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89123-2875
- American Institute of Medical Research
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New Jersey
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North Bergen, New Jersey, Förenta staterna, 07047
- Northern Valley Allergy, Asthma & Sinus Center
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New York
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Hawthorne, New York, Förenta staterna, 10532
- New York Medical College
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Horseheads, New York, Förenta staterna, 14845
- Corning Center for Clinical Research
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Hyde Park, New York, Förenta staterna, 11042
- Northwell Health Physician Partners
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New Windsor, New York, Förenta staterna, 12553
- Mid Hudson Medical Research PLLC
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North Carolina
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Asheville, North Carolina, Förenta staterna, 28803
- Allergy Partners of WNC
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Chapel Hill, North Carolina, Förenta staterna, 27599
- UNC Chapel Hill
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Charlotte, North Carolina, Förenta staterna, 28277
- OnSite Clinical Solutions LLC
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Elizabeth City, North Carolina, Förenta staterna, 27909-3465
- Atlantic Pulmonary Associates
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High Point, North Carolina, Förenta staterna, 27260
- Peters Medical Research, LLC
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Statesville, North Carolina, Förenta staterna, 28625
- Piedmont Healthcare, P.A.
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Wilmington, North Carolina, Förenta staterna, 28401
- Accellacare of Wilmington
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest Baptist Health
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45236
- Bernstein Clinical Research Center
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Columbus, Ohio, Förenta staterna, 43205
- Nationwide Childrens Hospital
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Dayton, Ohio, Förenta staterna, 45429
- PriMed Clinical Research
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Dayton, Ohio, Förenta staterna, 45404
- Daytons Children's Hospital
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Toledo, Ohio, Förenta staterna, 43617
- Toledo Institute of Clinical Research Inc
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Toledo, Ohio, Förenta staterna, 43606
- ProMedica Russell J. Ebeid Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73120-9389
- Allergy Asthma Clinical Research Cent
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Tulsa, Oklahoma, Förenta staterna, 74133
- Pulmonary & Sleep Center of Oklahoma
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Yukon, Oklahoma, Förenta staterna, 73099
- Tekton Research
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Oregon
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Grants Pass, Oregon, Förenta staterna, 97527
- Velocity Clinical Research, Grants Pass
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19140
- Temple University Hospital
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Pittsburgh, Pennsylvania, Förenta staterna, 15241
- Allergy and Clinical Immunology
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South Carolina
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North Charleston, South Carolina, Förenta staterna, 29420
- National Allergy and Asthma Research LLC.
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Rock Hill, South Carolina, Förenta staterna, 29732
- Clinical Research of Rock Hill
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37909
- Allergy Associates, PA dba Allergy, Asthma & Sinus Center
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Texas
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Austin, Texas, Förenta staterna, 78759
- Orion Clinical Research
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Boerne, Texas, Förenta staterna, 78006
- South Texas Medical Research Institute, Inc., DBA TTS Research
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Brownsville, Texas, Förenta staterna, 78520
- PanAmerican Clinical Research Brownsville
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Corsicana, Texas, Förenta staterna, 75110
- Corsicana Medical Research
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Dallas, Texas, Förenta staterna, 75235
- Southwest Family Medicine Associates
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Dallas, Texas, Förenta staterna, 75209
- Alina Clinical Trials, LLC, Barbara Baxter Sole MBR
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Dallas, Texas, Förenta staterna, 75231-8206
- AARA Research Center
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Edinburg, Texas, Förenta staterna, 78539
- Proactive Clinical Research LLC
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El Paso, Texas, Förenta staterna, 79902
- El Paso Pulmonary Association
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El Paso, Texas, Förenta staterna, 79912
- Western Sky Medical Research
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El Paso, Texas, Förenta staterna, 79902
- Proactive el Paso, LLC
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Houston, Texas, Förenta staterna, 77099
- Pioneer Research Solutions
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Houston, Texas, Förenta staterna, 77008
- Trio Clinical Trials
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Houston, Texas, Förenta staterna, 77065
- Innovative Medical Research of Texas LLC
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Houston, Texas, Förenta staterna, 77030
- Texas Children's Allergy and Immunology, Houston
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Houston, Texas, Förenta staterna, 77074-2005
- Clinical Trial Network
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Katy, Texas, Förenta staterna, 77494
- R & H Clinical Research
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Kerrville, Texas, Förenta staterna, 78028
- Sante Clinical Research LLC
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McKinney, Texas, Förenta staterna, 75069
- Metroplex Pulmonary and Sleep Center Drive
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San Antonio, Texas, Förenta staterna, 78229
- STAAMP Research, LLC
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San Antonio, Texas, Förenta staterna, 78258
- Element Research Group
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San Antonio, Texas, Förenta staterna, 78212
- Quality Assurance Research Center
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Sherman, Texas, Förenta staterna, 75090
- Sherman Clinical Research
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Splendora, Texas, Förenta staterna, 77372
- APD Clinical Research / PCP for Life
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Tomball, Texas, Förenta staterna, 77081
- DM Clinical Tomball
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Victoria, Texas, Förenta staterna, 77901
- Victoria Clinical Research Group
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Waxahachie, Texas, Förenta staterna, 75165-1430
- ClinPoint Trials
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Utah
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Bountiful, Utah, Förenta staterna, 84010
- Pantheon Clinical Research
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Sandy City, Utah, Förenta staterna, 84093
- Allergy Associates of Utah
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West Valley City, Utah, Förenta staterna, 84119
- Chronicle Bio
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Virginia
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Williamsburg, Virginia, Förenta staterna, 23188
- Tidewater Physicians Multispecialty Group (TPMG) Clinical Research
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Wisconsin
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Greenfield, Wisconsin, Förenta staterna, 53228
- Allergy, Asthma & Sinus Center
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-
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-
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Alexandroupoli, Grekland, 68100
- University General Hospital of Alexandroupolis
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Athens, Grekland, 10675
- Evaggelismos General Hospital
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Athens, Grekland, 11527
- General Pediatric Hospital Panayioti ans Aglaias Kyriakou
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Heraklion, Grekland, 71500
- University General Hospital of Heraklion
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Larissa, Grekland, 41 110
- University General Hospital of Larissa
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Thessaloniki, Grekland, 54639
- Pulmonary Clinic - Athens Medical Center SA, Interbalkan Medical Center of Thessaloniki
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Thessaloniki, Grekland, 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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-
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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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Alberta
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Edmonton, Alberta, Kanada, T6G2G3
- University of Alberta
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Ontario
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Ajax, Ontario, Kanada, l1s2j5
- Dynamic Drug Advancement
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Etobicoke, Ontario, Kanada, M9V 4B4
- Albion Finch Medical Centre
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Hamilton, Ontario, Kanada, L8S 1G5
- Triple A Lab
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Winchester, Ontario, Kanada, K0C 2K0
- Winchester Memorial Hospital
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Windsor, Ontario, Kanada, N8X 2G1
- Joel Liem Medicine Professional Corporation
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-
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-
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Balvi, Lettland, LV-4501
- Balvu and Gulbenes Hospital Association
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Daugavpils, Lettland, LV-5417
- Daugavpils Regional Hospital, Centre of Lung Diseases and Tuberculosis
-
Jūrmala, Lettland, LV-2015
- Health Center Association, Clinic Dubulti
-
Riga, Lettland, LV-1003
- The Centre of Investigation and Treatment of Allergic Diseases
-
Riga, Lettland, 1004
- LOR Clinic
-
Riga, Lettland, LV-1004
- Bernu KUS
-
Riga, Lettland, LV1010
- Consilium Medical
-
Rēzekne, Lettland, 4601
- Vevere Viktorija - Doctor's Practice in Pneumology and Allergology
-
-
-
-
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Chihuahua City, Mexiko, 31203
- Mediadvance Clinical
-
Guadalajara, Mexiko, 44670
- PanAmerican Clinical Research - Guadalajara
-
Guadalajara, Mexiko, 44100
- Instituto Jaliscience de Investigacion Clinica
-
Monterrey, Mexiko, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzl
-
Oaxaca City, Mexiko, 68000
- Oaxaca Site Management Organization S.C. (OSMO) - Investigacion Clinica
-
Villahermosa, Mexiko, 86035
- Consultorio De Especialidad Alergologia Pediatrica
-
-
-
-
-
Auckland, Nya Zeeland, 1010
- Optimal Clinical Trials Ltd
-
Auckland, Nya Zeeland, 626
- Optimal Clinical Trials - North
-
Christchurch, Nya Zeeland, 8013
- PCRN Forte
-
Dunedin, Nya Zeeland, 9016
- Momentum Dunedin
-
Hamilton, Nya Zeeland, 3204
- Waikato Hospital
-
Hamilton, Nya Zeeland, 3200
- Lakeland Clinical Trials Waikato
-
Hastings, Nya Zeeland, 4122
- P3 Research Ltd
-
Nelson, Nya Zeeland, 7011
- PCRN - Tasman
-
Rotorua, Nya Zeeland, 3010
- PCRN Rotorua
-
Tauranga, Nya Zeeland, 3110
- Clinical Horizons New Zealand Limited
-
Waikanae Beach, Nya Zeeland, 5036
- P3 Research Kapiti
-
Wellington, Nya Zeeland, 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, Rumänien, 600625
- Spital Pneumoftiziologi Bacau
-
Bragadiru, Rumänien, 769764
- Angisan Grup srl
-
Bucharest, Rumänien, 12052
- Quantum Medical Center
-
Bucharest, Rumänien, 41507
- Marius Nasta Pneumoftiziology Institute
-
Cluj-Napoca, Rumänien, 400371
- Spitalul Clinic de Pneumoftiziologie Leon Daniello
-
Craiova, Rumänien, 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, Slovakien, 08501
- Ns PSv. Jakuba
-
Kežmarok, Slovakien, 06224
- AlergoImuno centrum s.r.o. - Ambulancia alergologi
-
Košice, Slovakien, 040 11
- Paediatric University Hospital
-
Rimavská Sobota, Slovakien, 979 01
- Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie
-
Spišská Nová Ves, Slovakien, 052 01
- Plucna ambulancia Hrebenar, s.r.o.
-
Žilina, Slovakien, 01001
- Emin s.r.o.
-
Žilina, Slovakien, 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, Tjeckien, 25001
- MUDr. I. Cierna-Peterova s.r.o.
-
Brno, Tjeckien, 60200
- Fakultni Nemocnice u Sv. Anny - FNUSA
-
Jihlava, Tjeckien, 586 01
- Alergologie a imunologie MUDr. Hofstetr
-
Jindřichův Hradec, Tjeckien, 37701
- MediTrial s.r.o.
-
Lovosice, Tjeckien, 410 02
- CEFISPIRO s.r.o.
-
Ostrava, Tjeckien, 70900
- Alergologie SKOPKOVA s.r.o.
-
Prague, Tjeckien, 148 00
- Dawon s.r.o MU
-
Varnsdorf, Tjeckien, 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, Ungern, 1033
- Clinexpert Kft
-
Budapest, Ungern, 1094
- Semmelweis University
-
Budapest, Ungern, 1027
- High Tech Medical Kft
-
Debrecen, Ungern, 4027
- Orvostudomanyi Kutato es Fejleszto Kft.
-
Mosonmagyaróvár, Ungern, 9200
- Omnimodus Elixir KFT.
-
Pécs, Ungern, 7635
- Infer-Med Kft.
-
Szeged, Ungern, 6720
- Aranyklinika
-
Szigetvár, Ungern, 7900
- Spiroped Szigetvar Kft.
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
4 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Tid till första allvarliga kliniska astmaexacerbationen (CAE) med hög dos (HD) Fp/ABS eMDPI
Tidsram: Upp till 42 månader
|
Upp till 42 månader
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tid till första allvarliga CAE med låg dos (LD) Fp/ABS eMDPI
Tidsram: Upp till 42 månader
|
Upp till 42 månader
|
|
|
Antal deltagare med minst en allvarlig biverkning
Tidsram: Upp till 42 månader
|
Upp till 42 månader
|
|
|
Antal deltagare som avbröt studien på grund av behandlingsrelaterade biverkningar
Tidsram: Upp till 42 månader
|
Upp till 42 månader
|
|
|
Annualized Severe CAE Rate
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 augusti 2023
Primärt slutförande (Beräknad)
31 december 2026
Avslutad studie (Beräknad)
31 december 2026
Studieregistreringsdatum
Först inskickad
18 september 2023
Först inskickad som uppfyllde QC-kriterierna
18 september 2023
Första postat (Faktisk)
25 september 2023
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 november 2026
Senast verifierad
1 november 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FpA-AS-30094
- 2023-505435-12-00 (Registeridentifierare: CTIS (EU))
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .