En studie for å teste om en fastdosekombinasjon av flutikasonpropionat/albuterolsulfat er effektiv for å forhindre astmaforverring
2. november 2026 oppdatert av: Teva Branded Pharmaceutical Products R&D LLC
En randomisert, dobbeltblind, multisenter, aktiv-kontrollert, parallellgruppestudie for å evaluere effektiviteten og sikkerheten til flutikasonpropionat/albuterolsulfat-kombinasjon med fast dose på alvorlige astmaforverringer hos pasienter 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
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
2769
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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, Australia, 3128
- Eastern Health, Box Hill Hospital
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Clayton, Australia, 3168
- Monash Health
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Melbourne, Australia, 3004
- Alfred Health
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Midland, Australia, 6056
- Institute for Respiratory Health - Midland
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Nedlands, Australia, 6009
- Institute for Respiratory Health ,Sir Charles Gairdner Hospital
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North Adelaide, Australia, 5006
- Women's and Children's Hospital (WCH)
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Parkville, Australia, 3052
- The Royal Children's Hospital Melbourne
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South Brisbane, Australia, 4101
- Centre for Childrens Health Research
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Blagoevgrad, Bulgaria, 2700
- Multiprofile Hospital for Active Treatment Puls AD
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Kozloduy, Bulgaria, 3320
- Medical Center Zdrave 1 - OOD
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Pernik, Bulgaria, 2300
- DCC-1 Pernik
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Pleven, Bulgaria, 5800
- Medical Center MedConsult Pleven OOD
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Plovdiv, Bulgaria, 4002
- UMHAT Sveti Georgi
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Plovdiv, Bulgaria, 4002
- Medical Center Dar Plovdiv OOD
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Rousse, Bulgaria, 7002
- SHATPPD - Ruse Pulmonary Hospital
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Sliven, Bulgaria, 8800
- Diagnostic - Consultative Center - Sliven OOD
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Sofia, Bulgaria, 1407
- Medical Center Excelsior
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Sofia, Bulgaria, 1408
- DCC NeoClinic
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Sofia, Bulgaria, 1142
- First MHAT - Sofia
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Sofia, Bulgaria, 1421
- AGPSMP Pediatric Diseases South Park OOD
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Sofia, Bulgaria, 1431
- DKC Alexandrovska EOOD
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Sofia, Bulgaria, 1680
- Diagnostic - Consultative Center Convex EOOD
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Stara Zagora, Bulgaria, 6001
- Medical Center New Rehabilitation Center Ltd
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Varna, Bulgaria, 9000
- MC Research expert
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Vratsa, Bulgaria, 3001
- Specialized Hospital for Active Treatment of Pneumo-Phtisiatric Diseases Vratsa EOOD (SHATPPD- Vratsa)
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Alberta
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Edmonton, Alberta, Canada, T6G2G3
- University of Alberta
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Ontario
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Ajax, Ontario, Canada, l1s2j5
- Dynamic Drug Advancement
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Etobicoke, Ontario, Canada, M9V 4B4
- Albion Finch Medical Centre
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Hamilton, Ontario, Canada, L8S 1G5
- Triple A Lab
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Winchester, Ontario, Canada, K0C 2K0
- Winchester Memorial Hospital
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Windsor, Ontario, Canada, N8X 2G1
- Joel Liem Medicine Professional Corporation
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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, Forente stater, 35233
- The University of Alabama at Birmingham
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Birmingham, Alabama, Forente stater, 35209
- AllerVie Clnical Research
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Dothan, Alabama, Forente stater, 36305
- SEC Clinical Research
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Arizona
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Paradise Valley, Arizona, Forente stater, 85258
- One of a Kind Clinical Research Center LLC
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Scottsdale, Arizona, Forente stater, 85259
- Mayo Clinic
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Tucson, Arizona, Forente stater, 85741
- Novak Clinical Research
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California
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Bakersfield, California, Forente stater, 93301
- Kern Research, Inc
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Fresno, California, Forente stater, 93704
- Clinical Research of Central California, LLC
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Huntington Beach, California, Forente stater, 92647-6853
- Allergy and Asthma Specialists Medical Group
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La Jolla, California, Forente stater, 92037
- Orso Health
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La Palma, California, Forente stater, 90623
- IMAX Clinical Trials
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Long Beach, California, Forente stater, 90815
- Ark Clinical Research, LLC
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Long Beach, California, Forente stater, 90806-2613
- Long Beach Clinical Trials
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Los Angeles, California, Forente stater, 90025
- Ricardo Antonio Tan Inc
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Napa, California, Forente stater, 94558
- One of a Kind Clinical Research Center LLC
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Northridge, California, Forente stater, 91324
- California Medical Research Associates Inc.
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Redondo Beach, California, Forente stater, 90277-5720
- Riviera Allergy Medical Center
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San Bernardino, California, Forente stater, 92408
- Velocity Clinical Research, Banning
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San Diego, California, Forente stater, 92120
- Institute of HealthCare Assessment, Inc
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San Jose, California, Forente stater, 95117
- Allergy and Asthma Associates
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Stockton, California, Forente stater, 95207
- Bensch Clinical Research LLC
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Westminster, California, Forente stater, 92683
- Allianz Research Institute
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Colorado
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Aurora, Colorado, Forente stater, 80014
- Allianz Research Institute
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Colorado Springs, Colorado, Forente stater, 80907
- CRN Clinical Research Network LLC/Asthma and Allergy Associates P.C.
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Colorado Springs, Colorado, Forente stater, 80922
- OptumCare Colorado Springs LLC
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Englewood, Colorado, Forente stater, 80110
- Velocity Clinical Research
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20009
- Emerson Clinical Research Institute
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Florida
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Aventura, Florida, Forente stater, 33180
- Florida Center for Allergy and Asthma Research
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Cape Coral, Florida, Forente stater, 33914
- Renaissance Research and Medical Group
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Cutler Bay, Florida, Forente stater, 33189
- Cenara Clinical Research
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Doral, Florida, Forente stater, 33122
- D & H Doral Research Centers
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Greenacres City, Florida, Forente stater, 33476
- Finlay Medical Research Corp
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Hialeah, Florida, Forente stater, 33012
- Direct Helpers Research Center, Inc.
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Hialeah, Florida, Forente stater, 33012
- New Life Research Institute, LLC
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Homestead, Florida, Forente stater, 33030
- Homestead Medical Research
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Jacksonville, Florida, Forente stater, 32207
- Nemours Children Clinic
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Leesburg, Florida, Forente stater, 34748
- Clinical Site Partner, LLC DBA Flourish Research
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Margate, Florida, Forente stater, 33063
- D & H Pompano Research Centers, Inc.
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Miami, Florida, Forente stater, 33126
- Finlay Medical Research
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Miami, Florida, Forente stater, 33144
- Bio-Medical Research LLC
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Miami, Florida, Forente stater, 33186
- Phoenix Research Center, LLC
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Miami, Florida, Forente stater, 33173
- Century Research LLC
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Miami, Florida, Forente stater, 33155
- D & H National Research Centers, Inc.
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Miami, Florida, Forente stater, 33143
- Florida Pharmaceutical Research and Associates
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Miami, Florida, Forente stater, 33126
- EMDA Clinical Research
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Miami, Florida, Forente stater, 33126
- Life Arc Research Centers
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Miami, Florida, Forente stater, 33130
- Care Research Center
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Miami, Florida, Forente stater, 33142-2946
- Acevedo Clinical Research Associates
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Miami, Florida, Forente stater, 33144
- Y&L Advance Health Care, Inc. d/b/a Elite Clinical Research
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Miami, Florida, Forente stater, 33173
- Advance Medical Research Practice
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Miami, Florida, Forente stater, 33173
- Florida Center for Allergy and Asthma Research
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Miami, Florida, Forente stater, 33175
- ITB Research
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Miami, Florida, Forente stater, 33176
- DY Professional Research Center
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Miami, Florida, Forente stater, 33176
- IMIC INC
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Miami Lakes, Florida, Forente stater, 33014
- San Marcus Research Clinic, Inc.
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Miami Lakes, Florida, Forente stater, 33016
- Quality Research of South Florida
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Miami Lakes, Florida, Forente stater, 33014
- The Research Center
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Oldsmar, Florida, Forente stater, 34677
- Journey Research Inc.
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Orlando, Florida, Forente stater, 32819
- HMD Research LLC
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Orlando, Florida, Forente stater, 32806
- Anderson Allergy And Asthma, PA
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Orlando, Florida, Forente stater, 32825
- AHMG Pulmonology at East Orlando
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Pembroke Pines, Florida, Forente stater, 33025
- Pines Care Research Center LLC
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Sweetwater, Florida, Forente stater, 33182
- Cordova Research Institute, LLC
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Tamarac, Florida, Forente stater, 33321
- TBC Research Corp
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Tampa, Florida, Forente stater, 33604
- Wecare research center LLC
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Tampa, Florida, Forente stater, 33607-6327
- Clinical Research Trials of Florida, Inc.
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Tampa, Florida, Forente stater, 33607
- Nodal Medical Center, Llc
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Virginia Gardens, Florida, Forente stater, 33166
- Hope Research Network/CBS Laboratory
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Winter Park, Florida, Forente stater, 32789
- Florida Pediatric Research Institute
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Georgia
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Atlanta, Georgia, Forente stater, 30329
- Children's Healthcare of Atlanta Center for Advanced Pediatrics
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Conyers, Georgia, Forente stater, 30012
- Oracle Clinical Research
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Savannah, Georgia, Forente stater, 31406-2668
- Aeroallergy Research Laboratories of Savannah, Inc.
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Idaho
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Boise, Idaho, Forente stater, 83706
- Treasure Valley Medical Research
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forente stater, 60637
- University of Chicago
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Chicago, Illinois, Forente stater, 60607
- Cedar Crosse Research Center
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Skokie, Illinois, Forente stater, 60077
- Northshore University Health System Clinical Trials Center
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Indiana
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Evansville, Indiana, Forente stater, 47715
- Deaconess Clinic
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Kansas
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Overland Park, Kansas, Forente stater, 66210
- Velocity Clinical Research, Kansas City
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Kentucky
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Lexington, Kentucky, Forente stater, 40509
- Bluegrass Allergy Research
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Louisiana
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Lafayette, Louisiana, Forente stater, 70508
- Velocity Clinical Research - Lafayette
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Maine
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Bangor, Maine, Forente stater, 04401
- Paul A. Shapero M.D.
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Maryland
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Rockville, Maryland, Forente stater, 20852
- DelRicht Research @ Matthew Mintz Clinic
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White Marsh, Maryland, Forente stater, 21162
- Chesapeake Clinical Research Inc
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Brigham Womens Hospital
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Fall River, Massachusetts, Forente stater, 02723
- Exordia Medical Research Inc,
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North Dartmouth, Massachusetts, Forente stater, 02747
- Infinity Medical Research
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South Dartmouth, Massachusetts, Forente stater, 02747
- Mayflower Clinical Research
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford
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Flint, Michigan, Forente stater, 48507
- Onyx Clinical Research
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Ypsilanti, Michigan, Forente stater, 48197
- Respiratory Medicine Research Institute of Michigan
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Missouri
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Kansas City, Missouri, Forente stater, 66160
- University of Kansas School of Medicine
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St Louis, Missouri, Forente stater, 63110
- Washington University
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St Louis, Missouri, Forente stater, 63123
- Clayton Sleep Institute
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St Louis, Missouri, Forente stater, 63141-7068
- Midwest Clinical Research
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Nebraska
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Hastings, Nebraska, Forente stater, 68901
- Family Medical Center of Hastings
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Nevada
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Las Vegas, Nevada, Forente stater, 89123-2875
- American Institute of Medical Research
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New Jersey
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North Bergen, New Jersey, Forente stater, 07047
- Northern Valley Allergy, Asthma & Sinus Center
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New York
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Hawthorne, New York, Forente stater, 10532
- New York Medical College
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Horseheads, New York, Forente stater, 14845
- Corning Center for Clinical Research
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Hyde Park, New York, Forente stater, 11042
- Northwell Health Physician Partners
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New Windsor, New York, Forente stater, 12553
- Mid Hudson Medical Research PLLC
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North Carolina
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Asheville, North Carolina, Forente stater, 28803
- Allergy Partners of WNC
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Chapel Hill, North Carolina, Forente stater, 27599
- UNC Chapel Hill
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Charlotte, North Carolina, Forente stater, 28277
- OnSite Clinical Solutions LLC
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Elizabeth City, North Carolina, Forente stater, 27909-3465
- Atlantic Pulmonary Associates
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High Point, North Carolina, Forente stater, 27260
- Peters Medical Research, LLC
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Statesville, North Carolina, Forente stater, 28625
- Piedmont Healthcare, P.A.
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Wilmington, North Carolina, Forente stater, 28401
- Accellacare of Wilmington
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Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest Baptist Health
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Ohio
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Cincinnati, Ohio, Forente stater, 45236
- Bernstein Clinical Research Center
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Columbus, Ohio, Forente stater, 43205
- Nationwide Childrens Hospital
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Dayton, Ohio, Forente stater, 45429
- PriMed Clinical Research
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Dayton, Ohio, Forente stater, 45404
- Daytons Children's Hospital
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Toledo, Ohio, Forente stater, 43617
- Toledo Institute of Clinical Research Inc
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Toledo, Ohio, Forente stater, 43606
- ProMedica Russell J. Ebeid Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73120-9389
- Allergy Asthma Clinical Research Cent
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Tulsa, Oklahoma, Forente stater, 74133
- Pulmonary & Sleep Center of Oklahoma
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Yukon, Oklahoma, Forente stater, 73099
- Tekton Research
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Oregon
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Grants Pass, Oregon, Forente stater, 97527
- Velocity Clinical Research, Grants Pass
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19140
- Temple University Hospital
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Pittsburgh, Pennsylvania, Forente stater, 15241
- Allergy and Clinical Immunology
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South Carolina
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North Charleston, South Carolina, Forente stater, 29420
- National Allergy and Asthma Research LLC.
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Rock Hill, South Carolina, Forente stater, 29732
- Clinical Research of Rock Hill
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Tennessee
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Knoxville, Tennessee, Forente stater, 37909
- Allergy Associates, PA dba Allergy, Asthma & Sinus Center
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Texas
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Austin, Texas, Forente stater, 78759
- Orion Clinical Research
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Boerne, Texas, Forente stater, 78006
- South Texas Medical Research Institute, Inc., DBA TTS Research
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Brownsville, Texas, Forente stater, 78520
- PanAmerican Clinical Research Brownsville
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Corsicana, Texas, Forente stater, 75110
- Corsicana Medical Research
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Dallas, Texas, Forente stater, 75235
- Southwest Family Medicine Associates
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Dallas, Texas, Forente stater, 75209
- Alina Clinical Trials, LLC, Barbara Baxter Sole MBR
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Dallas, Texas, Forente stater, 75231-8206
- AARA Research Center
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Edinburg, Texas, Forente stater, 78539
- Proactive Clinical Research LLC
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El Paso, Texas, Forente stater, 79902
- El Paso Pulmonary Association
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El Paso, Texas, Forente stater, 79912
- Western Sky Medical Research
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El Paso, Texas, Forente stater, 79902
- Proactive el Paso, LLC
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Houston, Texas, Forente stater, 77099
- Pioneer Research Solutions
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Houston, Texas, Forente stater, 77008
- Trio Clinical Trials
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Houston, Texas, Forente stater, 77065
- Innovative Medical Research of Texas LLC
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Houston, Texas, Forente stater, 77030
- Texas Children's Allergy and Immunology, Houston
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Houston, Texas, Forente stater, 77074-2005
- Clinical Trial Network
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Katy, Texas, Forente stater, 77494
- R & H Clinical Research
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Kerrville, Texas, Forente stater, 78028
- Sante Clinical Research LLC
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McKinney, Texas, Forente stater, 75069
- Metroplex Pulmonary and Sleep Center Drive
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San Antonio, Texas, Forente stater, 78229
- STAAMP Research, LLC
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San Antonio, Texas, Forente stater, 78258
- Element Research Group
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San Antonio, Texas, Forente stater, 78212
- Quality Assurance Research Center
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Sherman, Texas, Forente stater, 75090
- Sherman Clinical Research
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Splendora, Texas, Forente stater, 77372
- APD Clinical Research / PCP for Life
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Tomball, Texas, Forente stater, 77081
- DM Clinical Tomball
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Victoria, Texas, Forente stater, 77901
- Victoria Clinical Research Group
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Waxahachie, Texas, Forente stater, 75165-1430
- ClinPoint Trials
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Utah
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Bountiful, Utah, Forente stater, 84010
- Pantheon Clinical Research
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Sandy City, Utah, Forente stater, 84093
- Allergy Associates of Utah
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West Valley City, Utah, Forente stater, 84119
- Chronicle Bio
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Virginia
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Williamsburg, Virginia, Forente stater, 23188
- Tidewater Physicians Multispecialty Group (TPMG) Clinical Research
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Wisconsin
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Greenfield, Wisconsin, Forente stater, 53228
- Allergy, Asthma & Sinus Center
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Alexandroupoli, Hellas, 68100
- University General Hospital of Alexandroupolis
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Athens, Hellas, 10675
- Evaggelismos General Hospital
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Athens, Hellas, 11527
- General Pediatric Hospital Panayioti ans Aglaias Kyriakou
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Heraklion, Hellas, 71500
- University General Hospital of Heraklion
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Larissa, Hellas, 41 110
- University General Hospital of Larissa
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Thessaloniki, Hellas, 54639
- Pulmonary Clinic - Athens Medical Center SA, Interbalkan Medical Center of Thessaloniki
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Thessaloniki, Hellas, 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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Ferrara, Italia, 44124
- AOU Ferrara - Arcispedale S.Anna
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Padova, Italia, 35128
- Azienda Ospedale - Universita Padova
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Pisa, Italia, 56126
- Azienda Ospedaliero Universitaria Pisana
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Verona, Italia, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
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Verona, Italia, 37131
- Azienda Ospedaliera Universitaria Integrata Verona (AOUI)
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-
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-
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Balvi, Latvia, LV-4501
- Balvu and Gulbenes Hospital Association
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Daugavpils, Latvia, LV-5417
- Daugavpils Regional Hospital, Centre of Lung Diseases and Tuberculosis
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Jūrmala, Latvia, LV-2015
- Health Center Association, Clinic Dubulti
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Riga, Latvia, LV-1003
- The Centre of Investigation and Treatment of Allergic Diseases
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Riga, Latvia, 1004
- LOR Clinic
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Riga, Latvia, LV-1004
- Bernu KUS
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Riga, Latvia, LV1010
- Consilium Medical
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Rēzekne, Latvia, 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
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Monterrey, Mexico, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzl
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Oaxaca City, Mexico, 68000
- Oaxaca Site Management Organization S.C. (OSMO) - Investigacion Clinica
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Villahermosa, Mexico, 86035
- Consultorio De Especialidad Alergologia Pediatrica
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Auckland, New Zealand, 1010
- Optimal Clinical Trials Ltd
-
Auckland, New Zealand, 626
- Optimal Clinical Trials - North
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Christchurch, New Zealand, 8013
- PCRN Forte
-
Dunedin, New Zealand, 9016
- Momentum Dunedin
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Hamilton, New Zealand, 3204
- Waikato Hospital
-
Hamilton, New Zealand, 3200
- Lakeland Clinical Trials Waikato
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Hastings, New Zealand, 4122
- P3 Research Ltd
-
Nelson, New Zealand, 7011
- PCRN - Tasman
-
Rotorua, New Zealand, 3010
- PCRN Rotorua
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Tauranga, New Zealand, 3110
- Clinical Horizons New Zealand Limited
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Waikanae Beach, New Zealand, 5036
- P3 Research Kapiti
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Wellington, New Zealand, 6021
- MRINZ
-
-
-
-
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Bialystok, Polen, 15-010
- Prywatny Gabinet Internistyczno - Alergologiczny
-
Bialystok, Polen, 15-430
- Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
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Bydgoszcz, Polen, 85-796
- Centrum Medyczne Pratia Bydgoszcz
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Elblag, Polen, 82-300
- Centrum Badan Klinicznych Agnieszka Mital
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Gdansk, Polen, 80-214
- University Clinical Center Medical University of Gdansk
-
Gdansk, Polen, 80-344
- Clinica Vitae Sp. z o.o.
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Krakow, Polen, 31-624
- Malopolskie Centrum Alergologii
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Krakow, Polen, 31-141
- Nzoz Atopia
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Lodz, Polen, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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Lublin, Polen, 20-089
- Przychodnia Alergopneuma
-
Lublin, Polen, 20-095
- Alergotest s.c. Specjalistyczne Centrum Medyczne
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Maków Podhalański, Polen, 34-220
- Makowskie Centrum Medyczne Hamernia Sp z oo
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Ostrowiec Świętokrzyski, Polen, 27-400
- Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
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Poznan, Polen, 60-693
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus
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Rzeszów, Polen, 35-051
- Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
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Skierniewice, Polen, 96-100
- Velocity Skierniewice spolka z ograniczona odpowiedzialnoscia
-
Warsaw, Polen, 00-632
- Centrum Zdrowia MDM
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Zawadzkie, Polen, 47-120
- Centrum Medyczne Lucyna Andrzej Dymek S.C.
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-
-
-
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Bacau, Romania, 600625
- Spital Pneumoftiziologi Bacau
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Bragadiru, Romania, 769764
- Angisan Grup srl
-
Bucharest, Romania, 12052
- Quantum Medical Center
-
Bucharest, Romania, 41507
- Marius Nasta Pneumoftiziology Institute
-
Cluj-Napoca, Romania, 400371
- Spitalul Clinic de Pneumoftiziologie Leon Daniello
-
Craiova, Romania, 200515
- Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes
-
-
-
-
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Belgrade, Serbia, 11080
- Clinical Hospital Center Zemun
-
Belgrade, Serbia, 11070
- Mother and Child Health Institute of Serbia
-
Belgrade, Serbia, 11000
- Cinic for pulmonary diseases, clinical center of Serbia
-
Belgrade, Serbia, 11000
- Municipal Institute for Lung Diseases and Tuberculosis
-
Belgrade, Serbia, 11000
- Univezitetska Decja Klinika Beograd (University Children's Hospital Belgrade)
-
Kamenitz, Serbia, 21204
- Institut za plucne bolesti Vojvodine
-
Kragujevac, Serbia, 34000
- Clinic for Pulmonology, University Clinical Center Kragujevac
-
Niš, Serbia, 18000
- Clinical Centre of Nis,Clinic for Lung Diseases
-
Novi Sad, Serbia, 21000
- Institute for Child and Youth Health Care
-
-
-
-
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Bardejov, Slovakia, 08501
- Ns PSv. Jakuba
-
Kežmarok, Slovakia, 06224
- AlergoImuno centrum s.r.o. - Ambulancia alergologi
-
Košice, Slovakia, 040 11
- Paediatric University Hospital
-
Rimavská Sobota, Slovakia, 979 01
- Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie
-
Spišská Nová Ves, Slovakia, 052 01
- Plucna ambulancia Hrebenar, s.r.o.
-
Žilina, Slovakia, 01001
- Emin s.r.o.
-
Žilina, Slovakia, 1001
- Alergologicka a imunologicka ambulancia
-
-
-
-
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Badalona, Spania, 8916
- Hospital Universitari Germans Trias I Pujol
-
Barcelona, Spania, 08017
- Pectus Respiratory Health (Giromed Institute)
-
Barcelona, Spania, 08035
- Hospital Materno Infantil, Planta 13
-
Córdoba, Spania, 14004
- Hopital Quironsalud Cordoba
-
Madrid, Spania, 28007
- Hospital General Universitario Gregorio Maranon
-
Sabadell, Spania, 8208
- Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
-
Santiago de Compostela, Spania, 15706
- Hospital Clinico Universitario de Santiago
-
Seville, Spania, 41013
- Hospital Universitario Virgen del Rocio
-
Valencia, Spania, 46015
- Hospital Arnau de Vilanova
-
-
-
-
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Seoul, Sør -Korea, 5505
- Asan Medical Center
-
Seoul, Sør -Korea, 04763
- Hanyang University Seoul Hospital
-
Seoul, Sør -Korea, 6591
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul, Sør -Korea, 3722
- Yonsei University Health System - Severance Hospital
-
Seoul, Sør -Korea, 1757
- Inje University Sanggye Paik Hospital
-
Seoul, Sør -Korea, 3312
- The Catholic University of Korea - Eunpyeong St. Marys Hospital
-
-
-
-
-
Benoni, Sør-Afrika, 1501
- Worthwhile Clinical Trials
-
Cape Town, Sør-Afrika, 7530
- TASK Applied Science
-
Cape Town, Sør-Afrika, 7700
- University of Cape Town Lung Institute
-
Cape Town, Sør-Afrika, 7530
- Tiervlei Trial Centre
-
Cape Town, Sør-Afrika, 7570
- Langeberg Clinical Trials (*Medicross)
-
Centurion, Sør-Afrika, 0157
- Global Clinical Trials
-
Chatsworth, Sør-Afrika, 4092
- Precise Clinical Solutions
-
Durban, Sør-Afrika, 4092
- Dr PJ Sebastian
-
Ennerdale, Sør-Afrika, 1830
- Reimed Ennerdale
-
Germiston, Sør-Afrika, 1401
- CRISMO Bertha Gxowa Research Centre
-
Johannesburg, Sør-Afrika, 2113
- Newtown Clinical Research Centre
-
Krugersdorp, Sør-Afrika, 1739
- Ubuntu Clinical Research
-
KwaDukuza, Sør-Afrika, 4450
- Office of Jeevren Reddy MBChB
-
Middelburg, Sør-Afrika, 1050
- Merclinico
-
Midrand, Sør-Afrika, 1685
- Midrand Medical Centre
-
Plettenberg Bay, Sør-Afrika, 6600
- Tsitsikamma Clinical Research Initiative Unit 6,
-
Polokwane, Sør-Afrika, 699
- Gole Biomed Research Centre
-
Pretoria, Sør-Afrika, 0181
- Into Research
-
Roodepoort, Sør-Afrika, 1724
- Roodepoort Medicross Clinical Research Centre
-
Somerset West, Sør-Afrika, 7130
- Helderberg Clinical Research Centre - Somerset West
-
Soweto, Sør-Afrika, 1868
- Bheki Mlangeni District Hospital
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-
-
-
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Brandýs nad Labem-Stará Boleslav, Tsjekkia, 25001
- MUDr. I. Cierna-Peterova s.r.o.
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Brno, Tsjekkia, 60200
- Fakultni Nemocnice u Sv. Anny - FNUSA
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Jihlava, Tsjekkia, 586 01
- Alergologie a imunologie MUDr. Hofstetr
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Jindřichův Hradec, Tsjekkia, 37701
- MediTrial s.r.o.
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Lovosice, Tsjekkia, 410 02
- CEFISPIRO s.r.o.
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Ostrava, Tsjekkia, 70900
- Alergologie SKOPKOVA s.r.o.
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Prague, Tsjekkia, 148 00
- Dawon s.r.o MU
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Varnsdorf, Tsjekkia, 40747
- PNEUMOLOGIE VARNSDORF s.r.o.
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-
-
-
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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
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Delitzsch, Tyskland, 4509
- Klifeck GmbH
-
Essen, Tyskland, 45239
- Universitaetsmedizin Essen, Ruhrlandklinik
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Frankfurt, Tyskland, 60596
- IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
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Frankfurt am Main, Tyskland, 60596
- Medaimun GmbH
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Hamburg, Tyskland, 20354
- Pneumologicum Hamburg
-
Hamburg, Tyskland, 22299
- ME Clinical Respiratory Research Hamburg Gmbh
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Hamburg, Tyskland, 22335
- Praxis Dr. Groth
-
Hanover, Tyskland, 30449
- Siteworks GmbH
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Ibbenbueren, Tyskland, 49477
- Gemeinschaftspraxis fur Pneumologie Allergologie und Schlafmedizin
-
Karlsruhe, Tyskland, D-76137
- Zentrum fuer klinische Studien Karlsruhe
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Leipzig, Tyskland, 04347
- POIS Sachsen GmbH
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Leipzig, Tyskland, 4299
- BAG Prof. G. Hoheisel/Dr. A. Bonitz Praxis fur Pneumologie und Allergologie -Studienzentrum
-
Mainz, Tyskland, 55128
- IKF Pneumologie Mainz
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München, Tyskland, 80539
- Pneumologie Odeonsplatz Dr. med. Jan Feimer
-
München, Tyskland, 81241
- Pneumologisches Studienzentrum Munchen-West
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Neu-Isenburg, Tyskland, 63623
- Ballenberger, Freytag, Wenisch ? Institut fur klinische Forschung GmbH
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Neuss, Tyskland, 41469
- Office of Juergen Funck, Dr.med.
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Peine, Tyskland, 31224
- Studienzentrum Dr.Schlenska
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Wiesbaden, Tyskland, 65189
- Velocity Clinical Research Wiesbaden
-
Witten, Tyskland, 58452
- Lungenpraxis Witten
-
-
-
-
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Budapest, Ungarn, 1033
- Clinexpert Kft
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Budapest, Ungarn, 1094
- Semmelweis University
-
Budapest, Ungarn, 1027
- High Tech Medical Kft
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Debrecen, Ungarn, 4027
- Orvostudomanyi Kutato es Fejleszto Kft.
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Mosonmagyaróvár, Ungarn, 9200
- Omnimodus Elixir KFT.
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Pécs, Ungarn, 7635
- Infer-Med Kft.
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Szeged, Ungarn, 6720
- Aranyklinika
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Szigetvár, Ungarn, 7900
- Spiroped Szigetvar Kft.
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
4 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Tid til første alvorlig klinisk astmaforverring (CAE) med høy dose (HD) Fp/ABS eMDPI
Tidsramme: Opptil 42 måneder
|
Opptil 42 måneder
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid til første alvorlig CAE med Lav Dose (LD) Fp/ABS eMDPI
Tidsramme: Opptil 42 måneder
|
Opptil 42 måneder
|
|
|
Antall deltakere med minst én alvorlig bivirkning
Tidsramme: Opptil 42 måneder
|
Opptil 42 måneder
|
|
|
Antall deltakere som trakk seg fra studien på grunn av behandlingsrelaterte bivirkninger
Tidsramme: Opptil 42 måneder
|
Opptil 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. august 2023
Primær fullføring (Antatt)
31. desember 2026
Studiet fullført (Antatt)
31. desember 2026
Datoer for studieregistrering
Først innsendt
18. september 2023
Først innsendt som oppfylte QC-kriteriene
18. september 2023
Først lagt ut (Faktiske)
25. september 2023
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FpA-AS-30094
- 2023-505435-12-00 (Registeridentifikator: CTIS (EU))
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .