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一项测试丙酸氟替卡松/硫酸沙丁胺醇固定剂量组合是否能有效预防哮喘恶化的研究

2026年11月2日更新者：Teva Branded Pharmaceutical Products R&D LLC

一项随机、双盲、多中心、活性对照、平行组研究，旨在评估丙酸氟替卡松/硫酸沙丁胺醇固定剂量组合对哮喘患者严重哮喘发作的疗效和安全性

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

研究概览

地位

主动，不招人

条件

哮喘

干预/治疗

研究类型

介入性

注册 (实际的)

2769

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

4年及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：四人间

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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.	药品：TEV-56248 Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
实验性的：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.	药品：TEV-56248 Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
有源比较器：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.	药品：Albuterol sulfate Oral inhalation powder

研究衡量的是什么？

主要结果指标

结果测量	大体时间
首次发生严重临床哮喘急性发作（CAE）的时间（使用高剂量（HD）Fp/ABS eMDPI）大体时间：最长42个月	最长42个月

次要结果测量

结果测量	措施说明	大体时间
低剂量（LD）Fp/ABS eMDPI首次严重CAE发生时间大体时间：长达42个月		长达42个月
发生至少一次严重不良事件的受试者数量大体时间：长达 42 个月		长达 42 个月
因治疗期间出现的不良事件而退出试验的参与者人数大体时间：长达42个月		长达42个月
Annualized Severe CAE Rate 大体时间：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 大体时间：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 大体时间：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) 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Teva Branded Pharmaceutical Products R&D LLC

调查人员

研究主任：Teva Medical Expert, MD、Teva Branded Pharmaceutical Products R&D LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年8月30日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2023年9月18日

首先提交符合 QC 标准的

2023年9月18日

首次发布 (实际的)

2023年9月25日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

一项测试丙酸氟替卡松/硫酸沙丁胺醇固定剂量组合是否能有效预防哮喘恶化的研究

一项随机、双盲、多中心、活性对照、平行组研究，旨在评估丙酸氟替卡松/硫酸沙丁胺醇固定剂量组合对哮喘患者严重哮喘发作的疗效和安全性

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品