플루티카손 프로피오네이트/알부테롤 황산염의 고정 용량 병용 요법이 천식 악화 예방에 효과적인지 테스트하기 위한 연구
2026년 11월 2일 업데이트: Teva Branded Pharmaceutical Products R&D LLC
천식 환자의 중증 천식 악화에 대한 플루티카손 프로피오네이트/알부테롤 황산염 고정 용량 병용요법의 유효성 및 안전성을 평가하기 위한 무작위, 이중 맹검, 다기관, 능동 대조, 병렬 그룹 연구
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
연구 개요
상태
상태
모집하지 않고 적극적으로
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
2769
단계
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alexandroupoli, 그리스, 68100
- University General Hospital of Alexandroupolis
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Athens, 그리스, 10675
- Evaggelismos General Hospital
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Athens, 그리스, 11527
- General Pediatric Hospital Panayioti ans Aglaias Kyriakou
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Heraklion, 그리스, 71500
- University General Hospital of Heraklion
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Larissa, 그리스, 41 110
- University General Hospital of Larissa
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Thessaloniki, 그리스, 54639
- Pulmonary Clinic - Athens Medical Center SA, Interbalkan Medical Center of Thessaloniki
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Thessaloniki, 그리스, 57 010
- General Hospital of 'Thessaloniki G. Papanikolaou'
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Benoni, 남아프리카, 1501
- Worthwhile Clinical Trials
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Cape Town, 남아프리카, 7530
- TASK Applied Science
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Cape Town, 남아프리카, 7700
- University of Cape Town Lung Institute
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Cape Town, 남아프리카, 7530
- Tiervlei Trial Centre
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Cape Town, 남아프리카, 7570
- Langeberg Clinical Trials (*Medicross)
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Centurion, 남아프리카, 0157
- Global Clinical Trials
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Chatsworth, 남아프리카, 4092
- Precise Clinical Solutions
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Durban, 남아프리카, 4092
- Dr PJ Sebastian
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Ennerdale, 남아프리카, 1830
- Reimed Ennerdale
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Germiston, 남아프리카, 1401
- CRISMO Bertha Gxowa Research Centre
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Johannesburg, 남아프리카, 2113
- Newtown Clinical Research Centre
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Krugersdorp, 남아프리카, 1739
- Ubuntu Clinical Research
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KwaDukuza, 남아프리카, 4450
- Office of Jeevren Reddy MBChB
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Middelburg, 남아프리카, 1050
- Merclinico
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Midrand, 남아프리카, 1685
- Midrand Medical Centre
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Plettenberg Bay, 남아프리카, 6600
- Tsitsikamma Clinical Research Initiative Unit 6,
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Polokwane, 남아프리카, 699
- Gole Biomed Research Centre
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Pretoria, 남아프리카, 0181
- Into Research
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Roodepoort, 남아프리카, 1724
- Roodepoort Medicross Clinical Research Centre
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Somerset West, 남아프리카, 7130
- Helderberg Clinical Research Centre - Somerset West
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Soweto, 남아프리카, 1868
- Bheki Mlangeni District Hospital
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Auckland, 뉴질랜드, 1010
- Optimal Clinical Trials Ltd
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Auckland, 뉴질랜드, 626
- Optimal Clinical Trials - North
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Christchurch, 뉴질랜드, 8013
- PCRN Forte
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Dunedin, 뉴질랜드, 9016
- Momentum Dunedin
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Hamilton, 뉴질랜드, 3204
- Waikato Hospital
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Hamilton, 뉴질랜드, 3200
- Lakeland Clinical Trials Waikato
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Hastings, 뉴질랜드, 4122
- P3 Research Ltd
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Nelson, 뉴질랜드, 7011
- PCRN - Tasman
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Rotorua, 뉴질랜드, 3010
- PCRN Rotorua
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Tauranga, 뉴질랜드, 3110
- Clinical Horizons New Zealand Limited
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Waikanae Beach, 뉴질랜드, 5036
- P3 Research Kapiti
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Wellington, 뉴질랜드, 6021
- MRINZ
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Seoul, 대한민국, 5505
- Asan Medical Center
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Seoul, 대한민국, 04763
- Hanyang University Seoul Hospital
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Seoul, 대한민국, 6591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, 대한민국, 3722
- Yonsei University Health System - Severance Hospital
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Seoul, 대한민국, 1757
- Inje University Sanggye Paik Hospital
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Seoul, 대한민국, 3312
- The Catholic University of Korea - Eunpyeong St. Marys Hospital
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-
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Aalborg, 덴마크, 9100
- Aalborg University Hospital
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Hvidovre, 덴마크, 2650
- Hvidovre Hospital
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Vejle, 덴마크, 7100
- Vejle Hospital
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-
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Augsburg, 독일, 86150
- Zentrum fur Pneumologie und Onkologie am Diako
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Berlin, 독일, 10119
- Studienpraxis Berlin-Brandenburg
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Berlin, 독일, 10717
- Research Center for Medical Studies RCMS
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Berlin, 독일, 12159
- Institut fur Allergie-und Asthmaforschung Berlin
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Cottbus, 독일, D-03050
- MECS Cottbus GmbH
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Darmstadt, 독일, 65283
- Pneumostudien Darmstadt GmbH
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Delitzsch, 독일, 4509
- Klifeck GmbH
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Essen, 독일, 45239
- Universitaetsmedizin Essen, Ruhrlandklinik
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Frankfurt, 독일, 60596
- IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
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Frankfurt am Main, 독일, 60596
- Medaimun GmbH
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Hamburg, 독일, 20354
- Pneumologicum Hamburg
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Hamburg, 독일, 22299
- ME Clinical Respiratory Research Hamburg Gmbh
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Hamburg, 독일, 22335
- Praxis Dr. Groth
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Hanover, 독일, 30449
- Siteworks GmbH
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Ibbenbueren, 독일, 49477
- Gemeinschaftspraxis fur Pneumologie Allergologie und Schlafmedizin
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Karlsruhe, 독일, D-76137
- Zentrum fuer klinische Studien Karlsruhe
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Leipzig, 독일, 04347
- POIS Sachsen GmbH
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Leipzig, 독일, 4299
- BAG Prof. G. Hoheisel/Dr. A. Bonitz Praxis fur Pneumologie und Allergologie -Studienzentrum
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Mainz, 독일, 55128
- IKF Pneumologie Mainz
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München, 독일, 80539
- Pneumologie Odeonsplatz Dr. med. Jan Feimer
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München, 독일, 81241
- Pneumologisches Studienzentrum Munchen-West
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Neu-Isenburg, 독일, 63623
- Ballenberger, Freytag, Wenisch ? Institut fur klinische Forschung GmbH
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Neuss, 독일, 41469
- Office of Juergen Funck, Dr.med.
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Peine, 독일, 31224
- Studienzentrum Dr.Schlenska
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Wiesbaden, 독일, 65189
- Velocity Clinical Research Wiesbaden
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Witten, 독일, 58452
- Lungenpraxis Witten
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Balvi, 라트비아, LV-4501
- Balvu and Gulbenes Hospital Association
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Daugavpils, 라트비아, LV-5417
- Daugavpils Regional Hospital, Centre of Lung Diseases and Tuberculosis
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Jūrmala, 라트비아, LV-2015
- Health Center Association, Clinic Dubulti
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Riga, 라트비아, LV-1003
- The Centre of Investigation and Treatment of Allergic Diseases
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Riga, 라트비아, 1004
- LOR Clinic
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Riga, 라트비아, LV-1004
- Bernu KUS
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Riga, 라트비아, LV1010
- Consilium Medical
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Rēzekne, 라트비아, 4601
- Vevere Viktorija - Doctor's Practice in Pneumology and Allergology
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Bacau, 루마니아, 600625
- Spital Pneumoftiziologi Bacau
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Bragadiru, 루마니아, 769764
- Angisan Grup srl
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Bucharest, 루마니아, 12052
- Quantum Medical Center
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Bucharest, 루마니아, 41507
- Marius Nasta Pneumoftiziology Institute
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Cluj-Napoca, 루마니아, 400371
- Spitalul Clinic de Pneumoftiziologie Leon Daniello
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Craiova, 루마니아, 200515
- Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes
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Chihuahua City, 멕시코, 31203
- Mediadvance Clinical
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Guadalajara, 멕시코, 44670
- PanAmerican Clinical Research - Guadalajara
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Guadalajara, 멕시코, 44100
- Instituto Jaliscience de Investigacion Clinica
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Monterrey, 멕시코, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzl
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Oaxaca City, 멕시코, 68000
- Oaxaca Site Management Organization S.C. (OSMO) - Investigacion Clinica
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Villahermosa, 멕시코, 86035
- Consultorio De Especialidad Alergologia Pediatrica
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Alabama
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Birmingham, Alabama, 미국, 35233
- The University of Alabama at Birmingham
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Birmingham, Alabama, 미국, 35209
- AllerVie Clnical Research
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Dothan, Alabama, 미국, 36305
- SEC Clinical Research
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Arizona
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Paradise Valley, Arizona, 미국, 85258
- One of a Kind Clinical Research Center LLC
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic
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Tucson, Arizona, 미국, 85741
- Novak Clinical Research
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California
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Bakersfield, California, 미국, 93301
- Kern Research, Inc
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Fresno, California, 미국, 93704
- Clinical Research of Central California, LLC
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Huntington Beach, California, 미국, 92647-6853
- Allergy and Asthma Specialists Medical Group
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La Jolla, California, 미국, 92037
- Orso Health
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La Palma, California, 미국, 90623
- IMAX Clinical Trials
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Long Beach, California, 미국, 90815
- Ark Clinical Research, LLC
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Long Beach, California, 미국, 90806-2613
- Long Beach Clinical Trials
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Los Angeles, California, 미국, 90025
- Ricardo Antonio Tan Inc
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Napa, California, 미국, 94558
- One of a Kind Clinical Research Center LLC
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Northridge, California, 미국, 91324
- California Medical Research Associates Inc.
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Redondo Beach, California, 미국, 90277-5720
- Riviera Allergy Medical Center
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San Bernardino, California, 미국, 92408
- Velocity Clinical Research, Banning
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San Diego, California, 미국, 92120
- Institute of HealthCare Assessment, Inc
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San Jose, California, 미국, 95117
- Allergy and Asthma Associates
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Stockton, California, 미국, 95207
- Bensch Clinical Research LLC
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Westminster, California, 미국, 92683
- Allianz Research Institute
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Colorado
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Aurora, Colorado, 미국, 80014
- Allianz Research Institute
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Colorado Springs, Colorado, 미국, 80907
- CRN Clinical Research Network LLC/Asthma and Allergy Associates P.C.
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Colorado Springs, Colorado, 미국, 80922
- OptumCare Colorado Springs LLC
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Englewood, Colorado, 미국, 80110
- Velocity Clinical Research
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20009
- Emerson Clinical Research Institute
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Florida
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Aventura, Florida, 미국, 33180
- Florida Center for Allergy and Asthma Research
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Cape Coral, Florida, 미국, 33914
- Renaissance Research and Medical Group
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Cutler Bay, Florida, 미국, 33189
- Cenara Clinical Research
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Doral, Florida, 미국, 33122
- D & H Doral Research Centers
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Greenacres City, Florida, 미국, 33476
- Finlay Medical Research Corp
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Hialeah, Florida, 미국, 33012
- Direct Helpers Research Center, Inc.
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Hialeah, Florida, 미국, 33012
- New Life Research Institute, LLC
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Homestead, Florida, 미국, 33030
- Homestead Medical Research
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Jacksonville, Florida, 미국, 32207
- Nemours Children Clinic
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Leesburg, Florida, 미국, 34748
- Clinical Site Partner, LLC DBA Flourish Research
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Margate, Florida, 미국, 33063
- D & H Pompano Research Centers, Inc.
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Miami, Florida, 미국, 33126
- Finlay Medical Research
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Miami, Florida, 미국, 33144
- Bio-Medical Research LLC
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Miami, Florida, 미국, 33186
- Phoenix Research Center, LLC
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Miami, Florida, 미국, 33173
- Century Research LLC
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Miami, Florida, 미국, 33155
- D & H National Research Centers, Inc.
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Miami, Florida, 미국, 33143
- Florida Pharmaceutical Research and Associates
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Miami, Florida, 미국, 33126
- EMDA Clinical Research
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Miami, Florida, 미국, 33126
- Life Arc Research Centers
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Miami, Florida, 미국, 33130
- Care Research Center
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Miami, Florida, 미국, 33142-2946
- Acevedo Clinical Research Associates
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Miami, Florida, 미국, 33144
- Y&L Advance Health Care, Inc. d/b/a Elite Clinical Research
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Miami, Florida, 미국, 33173
- Advance Medical Research Practice
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Miami, Florida, 미국, 33173
- Florida Center for Allergy and Asthma Research
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Miami, Florida, 미국, 33175
- ITB Research
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Miami, Florida, 미국, 33176
- DY Professional Research Center
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Miami, Florida, 미국, 33176
- IMIC INC
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Miami Lakes, Florida, 미국, 33014
- San Marcus Research Clinic, Inc.
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Miami Lakes, Florida, 미국, 33016
- Quality Research of South Florida
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Miami Lakes, Florida, 미국, 33014
- The Research Center
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Oldsmar, Florida, 미국, 34677
- Journey Research Inc.
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Orlando, Florida, 미국, 32819
- HMD Research LLC
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Orlando, Florida, 미국, 32806
- Anderson Allergy And Asthma, PA
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Orlando, Florida, 미국, 32825
- AHMG Pulmonology at East Orlando
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Pembroke Pines, Florida, 미국, 33025
- Pines Care Research Center LLC
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Sweetwater, Florida, 미국, 33182
- Cordova Research Institute, LLC
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Tamarac, Florida, 미국, 33321
- TBC Research Corp
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Tampa, Florida, 미국, 33604
- Wecare research center LLC
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Tampa, Florida, 미국, 33607-6327
- Clinical Research Trials of Florida, Inc.
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Tampa, Florida, 미국, 33607
- Nodal Medical Center, Llc
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Virginia Gardens, Florida, 미국, 33166
- Hope Research Network/CBS Laboratory
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Winter Park, Florida, 미국, 32789
- Florida Pediatric Research Institute
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Georgia
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Atlanta, Georgia, 미국, 30329
- Children's Healthcare of Atlanta Center for Advanced Pediatrics
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Conyers, Georgia, 미국, 30012
- Oracle Clinical Research
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Savannah, Georgia, 미국, 31406-2668
- Aeroallergy Research Laboratories of Savannah, Inc.
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Idaho
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Boise, Idaho, 미국, 83706
- Treasure Valley Medical Research
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Illinois
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Chicago, Illinois, 미국, 60612
- Rush University Medical Center
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Chicago, Illinois, 미국, 60637
- University of Chicago
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Chicago, Illinois, 미국, 60607
- Cedar Crosse Research Center
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Skokie, Illinois, 미국, 60077
- Northshore University Health System Clinical Trials Center
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Indiana
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Evansville, Indiana, 미국, 47715
- Deaconess Clinic
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Kansas
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Overland Park, Kansas, 미국, 66210
- Velocity Clinical Research, Kansas City
-
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Kentucky
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Lexington, Kentucky, 미국, 40509
- Bluegrass Allergy Research
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Louisiana
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Lafayette, Louisiana, 미국, 70508
- Velocity Clinical Research - Lafayette
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Maine
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Bangor, Maine, 미국, 04401
- Paul A. Shapero M.D.
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Maryland
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Rockville, Maryland, 미국, 20852
- DelRicht Research @ Matthew Mintz Clinic
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White Marsh, Maryland, 미국, 21162
- Chesapeake Clinical Research Inc
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham Womens Hospital
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Fall River, Massachusetts, 미국, 02723
- Exordia Medical Research Inc,
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North Dartmouth, Massachusetts, 미국, 02747
- Infinity Medical Research
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South Dartmouth, Massachusetts, 미국, 02747
- Mayflower Clinical Research
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Michigan
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Detroit, Michigan, 미국, 48202
- Henry Ford
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Flint, Michigan, 미국, 48507
- Onyx Clinical Research
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Ypsilanti, Michigan, 미국, 48197
- Respiratory Medicine Research Institute of Michigan
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Missouri
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Kansas City, Missouri, 미국, 66160
- University of Kansas School of Medicine
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St Louis, Missouri, 미국, 63110
- Washington University
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St Louis, Missouri, 미국, 63123
- Clayton Sleep Institute
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St Louis, Missouri, 미국, 63141-7068
- Midwest Clinical Research
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Nebraska
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Hastings, Nebraska, 미국, 68901
- Family Medical Center of Hastings
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Nevada
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Las Vegas, Nevada, 미국, 89123-2875
- American Institute of Medical Research
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New Jersey
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North Bergen, New Jersey, 미국, 07047
- Northern Valley Allergy, Asthma & Sinus Center
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New York
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Hawthorne, New York, 미국, 10532
- New York Medical College
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Horseheads, New York, 미국, 14845
- Corning Center for Clinical Research
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Hyde Park, New York, 미국, 11042
- Northwell Health Physician Partners
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New Windsor, New York, 미국, 12553
- Mid Hudson Medical Research PLLC
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North Carolina
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Asheville, North Carolina, 미국, 28803
- Allergy Partners of WNC
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Chapel Hill, North Carolina, 미국, 27599
- UNC Chapel Hill
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Charlotte, North Carolina, 미국, 28277
- OnSite Clinical Solutions LLC
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Elizabeth City, North Carolina, 미국, 27909-3465
- Atlantic Pulmonary Associates
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High Point, North Carolina, 미국, 27260
- Peters Medical Research, LLC
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Statesville, North Carolina, 미국, 28625
- Piedmont Healthcare, P.A.
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Wilmington, North Carolina, 미국, 28401
- Accellacare of Wilmington
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest Baptist Health
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Ohio
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Cincinnati, Ohio, 미국, 45236
- Bernstein Clinical Research Center
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Columbus, Ohio, 미국, 43205
- Nationwide Childrens Hospital
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Dayton, Ohio, 미국, 45429
- PriMed Clinical Research
-
Dayton, Ohio, 미국, 45404
- Daytons Children's Hospital
-
Toledo, Ohio, 미국, 43617
- Toledo Institute of Clinical Research Inc
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Toledo, Ohio, 미국, 43606
- ProMedica Russell J. Ebeid Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73120-9389
- Allergy Asthma Clinical Research Cent
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Tulsa, Oklahoma, 미국, 74133
- Pulmonary & Sleep Center of Oklahoma
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Yukon, Oklahoma, 미국, 73099
- Tekton Research
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Oregon
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Grants Pass, Oregon, 미국, 97527
- Velocity Clinical Research, Grants Pass
-
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19140
- Temple University Hospital
-
Pittsburgh, Pennsylvania, 미국, 15241
- Allergy and Clinical Immunology
-
-
South Carolina
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North Charleston, South Carolina, 미국, 29420
- National Allergy and Asthma Research LLC.
-
Rock Hill, South Carolina, 미국, 29732
- Clinical Research of Rock Hill
-
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Tennessee
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Knoxville, Tennessee, 미국, 37909
- Allergy Associates, PA dba Allergy, Asthma & Sinus Center
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Texas
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Austin, Texas, 미국, 78759
- Orion Clinical Research
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Boerne, Texas, 미국, 78006
- South Texas Medical Research Institute, Inc., DBA TTS Research
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Brownsville, Texas, 미국, 78520
- PanAmerican Clinical Research Brownsville
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Corsicana, Texas, 미국, 75110
- Corsicana Medical Research
-
Dallas, Texas, 미국, 75235
- Southwest Family Medicine Associates
-
Dallas, Texas, 미국, 75209
- Alina Clinical Trials, LLC, Barbara Baxter Sole MBR
-
Dallas, Texas, 미국, 75231-8206
- AARA Research Center
-
Edinburg, Texas, 미국, 78539
- Proactive Clinical Research LLC
-
El Paso, Texas, 미국, 79902
- El Paso Pulmonary Association
-
El Paso, Texas, 미국, 79912
- Western Sky Medical Research
-
El Paso, Texas, 미국, 79902
- Proactive el Paso, LLC
-
Houston, Texas, 미국, 77099
- Pioneer Research Solutions
-
Houston, Texas, 미국, 77008
- Trio Clinical Trials
-
Houston, Texas, 미국, 77065
- Innovative Medical Research of Texas LLC
-
Houston, Texas, 미국, 77030
- Texas Children's Allergy and Immunology, Houston
-
Houston, Texas, 미국, 77074-2005
- Clinical Trial Network
-
Katy, Texas, 미국, 77494
- R & H Clinical Research
-
Kerrville, Texas, 미국, 78028
- Sante Clinical Research LLC
-
McKinney, Texas, 미국, 75069
- Metroplex Pulmonary and Sleep Center Drive
-
San Antonio, Texas, 미국, 78229
- STAAMP Research, LLC
-
San Antonio, Texas, 미국, 78258
- Element Research Group
-
San Antonio, Texas, 미국, 78212
- Quality Assurance Research Center
-
Sherman, Texas, 미국, 75090
- Sherman Clinical Research
-
Splendora, Texas, 미국, 77372
- APD Clinical Research / PCP for Life
-
Tomball, Texas, 미국, 77081
- DM Clinical Tomball
-
Victoria, Texas, 미국, 77901
- Victoria Clinical Research Group
-
Waxahachie, Texas, 미국, 75165-1430
- ClinPoint Trials
-
-
Utah
-
Bountiful, Utah, 미국, 84010
- Pantheon Clinical Research
-
Sandy City, Utah, 미국, 84093
- Allergy Associates of Utah
-
West Valley City, Utah, 미국, 84119
- Chronicle Bio
-
-
Virginia
-
Williamsburg, Virginia, 미국, 23188
- Tidewater Physicians Multispecialty Group (TPMG) Clinical Research
-
-
Wisconsin
-
Greenfield, Wisconsin, 미국, 53228
- Allergy, Asthma & Sinus Center
-
-
-
-
-
Blagoevgrad, 불가리아, 2700
- Multiprofile Hospital for Active Treatment Puls AD
-
Kozloduy, 불가리아, 3320
- Medical Center Zdrave 1 - OOD
-
Pernik, 불가리아, 2300
- DCC-1 Pernik
-
Pleven, 불가리아, 5800
- Medical Center MedConsult Pleven OOD
-
Plovdiv, 불가리아, 4002
- UMHAT Sveti Georgi
-
Plovdiv, 불가리아, 4002
- Medical Center Dar Plovdiv OOD
-
Rousse, 불가리아, 7002
- SHATPPD - Ruse Pulmonary Hospital
-
Sliven, 불가리아, 8800
- Diagnostic - Consultative Center - Sliven OOD
-
Sofia, 불가리아, 1407
- Medical Center Excelsior
-
Sofia, 불가리아, 1408
- DCC NeoClinic
-
Sofia, 불가리아, 1142
- First MHAT - Sofia
-
Sofia, 불가리아, 1421
- AGPSMP Pediatric Diseases South Park OOD
-
Sofia, 불가리아, 1431
- DKC Alexandrovska EOOD
-
Sofia, 불가리아, 1680
- Diagnostic - Consultative Center Convex EOOD
-
Stara Zagora, 불가리아, 6001
- Medical Center New Rehabilitation Center Ltd
-
Varna, 불가리아, 9000
- MC Research expert
-
Vratsa, 불가리아, 3001
- Specialized Hospital for Active Treatment of Pneumo-Phtisiatric Diseases Vratsa EOOD (SHATPPD- Vratsa)
-
-
-
-
-
Belgrade, 세르비아, 11080
- Clinical Hospital Center Zemun
-
Belgrade, 세르비아, 11070
- Mother and Child Health Institute of Serbia
-
Belgrade, 세르비아, 11000
- Cinic for pulmonary diseases, clinical center of Serbia
-
Belgrade, 세르비아, 11000
- Municipal Institute for Lung Diseases and Tuberculosis
-
Belgrade, 세르비아, 11000
- Univezitetska Decja Klinika Beograd (University Children's Hospital Belgrade)
-
Kamenitz, 세르비아, 21204
- Institut za plucne bolesti Vojvodine
-
Kragujevac, 세르비아, 34000
- Clinic for Pulmonology, University Clinical Center Kragujevac
-
Niš, 세르비아, 18000
- Clinical Centre of Nis,Clinic for Lung Diseases
-
Novi Sad, 세르비아, 21000
- Institute for Child and Youth Health Care
-
-
-
-
-
Badalona, 스페인, 8916
- Hospital Universitari Germans Trias I Pujol
-
Barcelona, 스페인, 08017
- Pectus Respiratory Health (Giromed Institute)
-
Barcelona, 스페인, 08035
- Hospital Materno Infantil, Planta 13
-
Córdoba, 스페인, 14004
- Hopital Quironsalud Cordoba
-
Madrid, 스페인, 28007
- Hospital General Universitario Gregorio Maranon
-
Sabadell, 스페인, 8208
- Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
-
Santiago de Compostela, 스페인, 15706
- Hospital Clinico Universitario de Santiago
-
Seville, 스페인, 41013
- Hospital Universitario Virgen del Rocio
-
Valencia, 스페인, 46015
- Hospital Arnau de Vilanova
-
-
-
-
-
Bardejov, 슬로바키아, 08501
- Ns PSv. Jakuba
-
Kežmarok, 슬로바키아, 06224
- AlergoImuno centrum s.r.o. - Ambulancia alergologi
-
Košice, 슬로바키아, 040 11
- Paediatric University Hospital
-
Rimavská Sobota, 슬로바키아, 979 01
- Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie
-
Spišská Nová Ves, 슬로바키아, 052 01
- Plucna ambulancia Hrebenar, s.r.o.
-
Žilina, 슬로바키아, 01001
- Emin s.r.o.
-
Žilina, 슬로바키아, 1001
- Alergologicka a imunologicka ambulancia
-
-
-
-
-
Bahía Blanca, 아르헨티나, B8000JRB
- Instituto de Alergia e Inmunologia del Sur - IAIS
-
Bahía Blanca, 아르헨티나, B8001AAD
- CEC Consultorios de Especialidades Cardiovasculares
-
Bahía Blanca, 아르헨티나, B8001DDU
- Hospital Interzonal Dr Jose Penna Bahia Blanca
-
Buenos Aires, 아르헨티나, C1121ABE
- Fundacion CIDEA
-
Buenos Aires, 아르헨티나, C1128AAF
- Mautalen Salud e Investigacion
-
Buenos Aires, 아르헨티나, C1425BEN
- InAER
-
Buenos Aires, 아르헨티나, C1426ABP
- Consultorio Medico Dra. Rivera
-
Buenos Aires, 아르헨티나, C1426ABP
- Consultorios Medicos Dr. Doreski - Fundacion Respirar
-
CABA, 아르헨티나, 1414
- CARE - Centro de Alergia y Enfermedades Respiratorias
-
CABA, 아르헨티나, C1426ABP
- Fundacion Respirar-Consultorios Dr. Doreski
-
Concepción del Uruguay, 아르헨티나, 3260
- Centro de Medicina Respiratoria
-
Córdoba, 아르헨티나, X5003DCE
- Instituto de Medicina Respiratoria, IMeR
-
Florida, 아르헨티나, B1602DQD
- CEMER Centro Medico de Enfermedades Respiratorias
-
Godoy Cruz, 아르헨티나, 5501
- Respira Salud Clinica Integral
-
Lanus, 아르헨티나, 1824
- CIMeL
-
Lobos, 아르헨티나, B7240KJB
- CEMLO-Centro Especialidades Medicas Lobos
-
Mar del Plata, 아르헨티나, B7612ENA
- Fundacion Enfisema
-
Mar del Plata, 아르헨티나, 7600
- Centro de Investigaciones Medicas Mar del Plata (CIM-MDP)
-
Mendoza, 아르헨티나, 5500
- Fundacion Scherbovsky
-
Mendoza, 아르헨티나, M55000CBA
- Dharma Centro Medico
-
Mendoza, 아르헨티나, M5500CCA
- INSARES
-
Mendoza, 아르헨티나, M5507XAF
- Polo de Salud Vistalba
-
Paraná, 아르헨티나, E3100XAI
- Centro Privado de Medicina Respiratoria
-
Quilmes, 아르헨티나, 1878
- Centro Respiratorio Quilmes
-
Rosario, 아르헨티나, 2000
- Sanatorio Ipam
-
Rosario, 아르헨티나, S2000 DEJ
- Fundacion Estudios Clinicos (FECLIN)
-
Rosario, 아르헨티나, S2000JKR
- Instituto de Diagnostico ABC
-
San Fernando, 아르헨티나, B1646EBJ
- Centro Medico Respire
-
San Juan Bautista, 아르헨티나, 1888
- IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica
-
San Miguel de Tucumán, 아르헨티나, 4000
- Centro Integral de Medicina Respiratoria (CIMER)
-
San Miguel de Tucumán, 아르헨티나, 4000
- Clinica Mayo de UMCB SRL
-
San Miguel de Tucumán, 아르헨티나, 4000
- Investigaciones En Patologias Respiratorias
-
San Miguel de Tucumán, 아르헨티나, T4000EGH
- Centro Modelo de Cardiologa SRL
-
San Rafael, 아르헨티나, M5602GGS
- Cimro Consultorios Medicos - Centro de Investigacion
-
Santa Fe, 아르헨티나, S3000ASF
- Instituto del Buen Aire
-
-
-
-
-
Ashkelon, 이스라엘, 7830604
- Barzilai Medical Center
-
Beersheba, 이스라엘, 8457108
- Soroka University Medical Center
-
Haifa, 이스라엘, 3109601
- Rambam Health Care Campus - The Ruth Rappaport Children's Hospital
-
Jerusalem, 이스라엘, 9103102
- Shaare Zedek Medical Center - Pulmonary Institute
-
Jerusalem, 이스라엘, 9112010
- The Hadassah University Hospital-Ein Kerem - Institute of Pulmonology
-
Petach Tikvah, 이스라엘, 4920235
- Kipper Institute of Allergy and Immunology at Schneider Children's Medical Center of Israel
-
Petah Tikva, 이스라엘, 4941492
- Rabin Medical Center
-
Rehovot, 이스라엘, 7661041
- Kaplan Medical Center
-
Tel Aviv, 이스라엘, 6423906
- Tel Aviv Sourasky Medical Center - Ichilov
-
-
-
-
-
Ferrara, 이탈리아, 44124
- AOU Ferrara - Arcispedale S.Anna
-
Padova, 이탈리아, 35128
- Azienda Ospedale - Universita Padova
-
Pisa, 이탈리아, 56126
- Azienda Ospedaliero Universitaria Pisana
-
Verona, 이탈리아, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
-
Verona, 이탈리아, 37131
- Azienda Ospedaliera Universitaria Integrata Verona (AOUI)
-
-
-
-
-
Brandýs nad Labem-Stará Boleslav, 체코, 25001
- MUDr. I. Cierna-Peterova s.r.o.
-
Brno, 체코, 60200
- Fakultni Nemocnice u Sv. Anny - FNUSA
-
Jihlava, 체코, 586 01
- Alergologie a imunologie MUDr. Hofstetr
-
Jindřichův Hradec, 체코, 37701
- MediTrial s.r.o.
-
Lovosice, 체코, 410 02
- CEFISPIRO s.r.o.
-
Ostrava, 체코, 70900
- Alergologie SKOPKOVA s.r.o.
-
Prague, 체코, 148 00
- Dawon s.r.o MU
-
Varnsdorf, 체코, 40747
- PNEUMOLOGIE VARNSDORF s.r.o.
-
-
-
-
Alberta
-
Edmonton, Alberta, 캐나다, T6G2G3
- University of Alberta
-
-
Ontario
-
Ajax, Ontario, 캐나다, l1s2j5
- Dynamic Drug Advancement
-
Etobicoke, Ontario, 캐나다, M9V 4B4
- Albion Finch Medical Centre
-
Hamilton, Ontario, 캐나다, L8S 1G5
- Triple A Lab
-
Winchester, Ontario, 캐나다, K0C 2K0
- Winchester Memorial Hospital
-
Windsor, Ontario, 캐나다, N8X 2G1
- Joel Liem Medicine Professional Corporation
-
-
-
-
-
Bialystok, 폴란드, 15-010
- Prywatny Gabinet Internistyczno - Alergologiczny
-
Bialystok, 폴란드, 15-430
- Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
-
Bydgoszcz, 폴란드, 85-796
- Centrum Medyczne Pratia Bydgoszcz
-
Elblag, 폴란드, 82-300
- Centrum Badan Klinicznych Agnieszka Mital
-
Gdansk, 폴란드, 80-214
- University Clinical Center Medical University of Gdansk
-
Gdansk, 폴란드, 80-344
- Clinica Vitae Sp. z o.o.
-
Krakow, 폴란드, 31-624
- Malopolskie Centrum Alergologii
-
Krakow, 폴란드, 31-141
- Nzoz Atopia
-
Lodz, 폴란드, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
Lublin, 폴란드, 20-089
- Przychodnia Alergopneuma
-
Lublin, 폴란드, 20-095
- Alergotest s.c. Specjalistyczne Centrum Medyczne
-
Maków Podhalański, 폴란드, 34-220
- Makowskie Centrum Medyczne Hamernia Sp z oo
-
Ostrowiec Świętokrzyski, 폴란드, 27-400
- Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
-
Poznan, 폴란드, 60-693
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus
-
Rzeszów, 폴란드, 35-051
- Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
-
Skierniewice, 폴란드, 96-100
- Velocity Skierniewice spolka z ograniczona odpowiedzialnoscia
-
Warsaw, 폴란드, 00-632
- Centrum Zdrowia MDM
-
Zawadzkie, 폴란드, 47-120
- Centrum Medyczne Lucyna Andrzej Dymek S.C.
-
-
-
-
-
Budapest, 헝가리, 1033
- Clinexpert Kft
-
Budapest, 헝가리, 1094
- Semmelweis University
-
Budapest, 헝가리, 1027
- High Tech Medical Kft
-
Debrecen, 헝가리, 4027
- Orvostudomanyi Kutato es Fejleszto Kft.
-
Mosonmagyaróvár, 헝가리, 9200
- Omnimodus Elixir KFT.
-
Pécs, 헝가리, 7635
- Infer-Med Kft.
-
Szeged, 헝가리, 6720
- Aranyklinika
-
Szigetvár, 헝가리, 7900
- Spiroped Szigetvar Kft.
-
-
-
-
-
Box Hill, 호주, 3128
- Eastern Health, Box Hill Hospital
-
Clayton, 호주, 3168
- Monash Health
-
Melbourne, 호주, 3004
- Alfred Health
-
Midland, 호주, 6056
- Institute for Respiratory Health - Midland
-
Nedlands, 호주, 6009
- Institute for Respiratory Health ,Sir Charles Gairdner Hospital
-
North Adelaide, 호주, 5006
- Women's and Children's Hospital (WCH)
-
Parkville, 호주, 3052
- The Royal Children's Hospital Melbourne
-
South Brisbane, 호주, 4101
- Centre for Childrens Health Research
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
4년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
실험적: 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. |
|
활성 비교기: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
고용량(HD) Fp/ABS eMDPI 사용 시 첫 번째 중증 임상 천식 악화(CAE) 발생 시간
기간: 최대 42개월
|
최대 42개월
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
저용량(LD) Fp/ABS eMDPI 투여 후 첫 번째 중증 CAE 발생까지의 시간
기간: 최대 42개월
|
최대 42개월
|
|
|
심각한 이상사건이 최소 1회 이상 발생한 참가자 수
기간: 최대 42개월
|
최대 42개월
|
|
|
치료 관련 이상반응으로 시험에서 철회한 참가자 수
기간: 최대 42개월
|
최대 42개월
|
|
|
Annualized Severe CAE Rate
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 책임자: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2023년 8월 30일
기본 완료 (추정된)
기본 완료
2026년 12월 31일
연구 완료 (추정된)
연구 완료
2026년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2023년 9월 18일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2023년 9월 18일
처음 게시됨 (실제)
처음 게시됨
2023년 9월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 11월 4일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 11월 2일
마지막으로 확인됨
마지막으로 확인됨
2026년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- FpA-AS-30094
- 2023-505435-12-00 (레지스트리 식별자: CTIS (EU))
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .