A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

November 2, 2026 updated by: Teva Branded Pharmaceutical Products R&D LLC

A Randomized, Double-Blind, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Fixed-Dose Combination on Severe Asthma Exacerbations in Patients With Asthma

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2769

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: TEV-56248

Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Experimental: 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.
Drug: TEV-56248

Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Active Comparator: 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.
Drug: Albuterol sulfate

Oral inhalation powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI
Time Frame: Up to 42 months
Up to 42 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first severe CAE with Low Dose (LD) Fp/ABS eMDPI
Time Frame: Up to 42 months
Up to 42 months
Number of Participants with at Least One Serious Adverse Event
Time Frame: Up to 42 months
Up to 42 months
Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events
Time Frame: Up to 42 months
Up to 42 months
Annualized Severe CAE Rate
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Investigators

  • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FpA-AS-30094
  • 2023-505435-12-00 (Registry Identifier: CTIS (EU))
  • 2023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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