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

May 21, 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

Asthma

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2772

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
    - Teva Investigational Site 20126
  - Bahía Blanca, Argentina, B8001AAD
    - Teva Investigational Site 20130
  - Bahía Blanca, Argentina, B8001DDU
    - Teva Investigational Site 20109
  - Buenos Aires, Argentina, C1121ABE
    - Teva Investigational Site 20113
  - Buenos Aires, Argentina, C1128AAF
    - Teva Investigational Site 20135
  - Buenos Aires, Argentina, C1426ABP
    - Teva Investigational Site 20111
  - Buenos Aires, Argentina, C1426ABP
    - Teva Investigational Site 20138
  - Buenos Aires Province, Argentina, 7600
    - Teva Investigational Site 20117
  - CABA, Argentina, 1414
    - Teva Investigational Site 20128
  - CABA, Argentina, C1426ABP
    - Teva Investigational Site 20139
  - CapitalFederal, Argentina, C1425BEN
    - Teva Investigational Site 20129
  - Concepción del Uruguay, Argentina, 3260
    - Teva Investigational Site 20118
  - Córdoba, Argentina, X5003DCE
    - Teva Investigational Site 20106
  - Florida, Vicente Lopez, Argentina, B1602DQD
    - Teva Investigational Site 20125
  - Godoy Cruz, Argentina, 5501
    - Teva Investigational Site 20136
  - Lanús Este, Argentina, 1824
    - Teva Investigational Site 20122
  - Lobos, Argentina, B7240KJB
    - Teva Investigational Site 20107
  - Mar del Plata, Argentina, B7612ENA
    - Teva Investigational Site 20123
  - Mendoza, Argentina, M5500CCA
    - Teva Investigational Site 20110
  - Mendoza, Argentina, 5500
    - Teva Investigational Site 20121
  - Mendoza, Argentina, M55000CBA
    - Teva Investigational Site 20115
  - Mendoza, Argentina, M5507XAF
    - Teva Investigational Site 20127
  - Paraná, Argentina, E3100XAI
    - Teva Investigational Site 20140
  - Quilmes, Argentina, 1878
    - Teva Investigational Site 20112
  - Rosario, Argentina, 2000
    - Teva Investigational Site 20119
  - Rosario, Argentina, S2000 DEJ
    - Teva Investigational Site 20105
  - Rosario, Argentina, S2000JKR
    - Teva Investigational Site 20120
  - San Fernando, Argentina, B1646EBJ
    - Teva Investigational Site 20133
  - San Juan Bautista, Argentina, 1888
    - Teva Investigational Site 20114
  - San Miguel de Tucumán, Argentina, 4000
    - Teva Investigational Site 20104
  - San Miguel de Tucumán, Argentina, 4000
    - Teva Investigational Site 20124
  - San Miguel de Tucumán, Argentina, 4000
    - Teva Investigational Site 20131
  - San Miguel de Tucumán, Argentina, T4000EGH
    - Teva Investigational Site 20137
  - San Rafael, Argentina, M5602GGS
    - Teva Investigational Site 20116
  - Santa Fe, Argentina, S3000ASF
    - Teva Investigational Site 20132
Australia
- - Box Hill, Australia, 3128
    - Teva Investigational Site 78131
  - Clayton, Australia, 3168
    - Teva Investigational Site 78135
  - Melbourne, Australia, 3004
    - Teva Investigational Site 78133
  - Midland, Australia, 6056
    - Teva Investigational Site 78132
  - Nedlands, Australia, 6009
    - Teva Investigational Site 78130
  - North Adelaide, Australia, 5006
    - Teva Investigational Site 78134
  - Parkville, Australia, 3052
    - Teva Investigational Site 78128
  - South Brisbane, Australia, 4101
    - Teva Investigational Site 78127
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - Teva Investigational Site 59230
  - Kozloduy, Bulgaria, 3320
    - Teva Investigational Site 59227
  - Pernik, Bulgaria, 2300
    - Teva Investigational Site 59218
  - Pleven, Bulgaria, 5800
    - Teva Investigational Site 59237
  - Plovdiv, Bulgaria, 4002
    - Teva Investigational Site 59222
  - Plovdiv, Bulgaria, 4002
    - Teva Investigational Site 59233
  - Rousse, Bulgaria, 7002
    - Teva Investigational Site 59219
  - Sliven, Bulgaria, 8800
    - Teva Investigational Site 59231
  - Sofia, Bulgaria, 1142
    - Teva Investigational Site 59224
  - Sofia, Bulgaria, 1407
    - Teva Investigational Site 59226
  - Sofia, Bulgaria, 1421
    - Teva Investigational Site 59228
  - Sofia, Bulgaria, 1680
    - Teva Investigational Site 59221
  - Sofia, Bulgaria, 1408
    - Teva Investigational Site 59235
  - Sofia, Bulgaria, 1431
    - Teva Investigational Site 59234
  - Stara Zagora, Bulgaria, 6001
    - Teva Investigational Site 59220
  - Varna, Bulgaria, 9000
    - Teva Investigational Site 59232
  - Vratsa, Bulgaria, 3001
    - Teva Investigational Site 59229
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G2G3
    - Teva Investigational Site 11267
- Ontario
  - Ajax, Ontario, Canada, l1s2j5
    - Teva Investigational Site 11272
  - Etobicoke, Ontario, Canada, M9V 4B4
    - Teva Investigational Site 11270
  - Hamilton, Ontario, Canada, L8S 1G5
    - Teva Investigational Site 11274
  - Winchester, Ontario, Canada, K0C 2K0
    - Teva Investigational Site 11271
  - Windsor, Ontario, Canada, N8X 2G1
    - Teva Investigational Site 11273
Czechia
- - Brandýs nad Labem-Stará Boleslav, Czechia, 25001
    - Teva Investigational Site 54231
  - Brno, Czechia, 60200
    - Teva Investigational Site 54232
  - Jihlava, Czechia, 586 01
    - Teva Investigational Site 54229
  - Jindřichův Hradec, Czechia, 37701
    - Teva Investigational Site 54226
  - Lovosice, Czechia, 410 02
    - Teva Investigational Site 54225
  - Ostrava, Czechia, 70900
    - Teva Investigational Site 54228
  - Prague, Czechia, 148 00
    - Teva Investigational Site 54230
  - Varnsdorf, Czechia, 40747
    - Teva Investigational Site 54227
Denmark
- - Aalborg, Denmark, 9100
    - Teva Investigational Site 39099
  - Hvidovre, Denmark, 2650
    - Teva Investigational Site 39100
  - Vejle, Denmark, 7100
    - Teva Investigational Site 39098
Germany
- - Augsburg, Germany, 86150
    - Teva Investigational Site 32846
  - Berlin, Germany, 10119
    - Teva Investigational Site 32835
  - Berlin, Germany, 10717
    - Teva Investigational Site 32834
  - Berlin, Germany, 12159
    - Teva Investigational Site 32833
  - Cottbus, Germany, D-03050
    - Teva Investigational Site 32840
  - Darmstadt, Germany, 65283
    - Teva Investigational Site 32829
  - Delitzsch, Germany, 4509
    - Teva Investigational Site 32850
  - Essen, Germany, 45239
    - Teva Investigational Site 32853
  - Frankfurt, Germany, 60596
    - Teva Investigational Site 32831
  - Frankfurt am Main, Germany, 60596
    - Teva Investigational Site 32845
  - Hamburg, Germany, 20354
    - Teva Investigational Site 32838
  - Hamburg, Germany, 22299
    - Teva Investigational Site 32827
  - Hamburg, Germany, 22335
    - Teva Investigational Site 32848
  - Hanover, Germany, 30449
    - Teva Investigational Site 32841
  - Ibbenbueren, Germany, 49477
    - Teva Investigational Site 32851
  - Karlsruhe, Germany, D-76137
    - Teva Investigational Site 32842
  - Leipzig, Germany, 4299
    - Teva Investigational Site 32844
  - Leipzig - Nordost, Germany, 04347
    - Teva Investigational Site 32830
  - Mainz A. Rhein, Germany, 55128
    - Teva Investigational Site 32832
  - München, Germany, 80539
    - Teva Investigational Site 32847
  - München, Germany, 81241
    - Teva Investigational Site 32828
  - Neu-Isenburg, Germany, 63623
    - Teva Investigational Site 32843
  - Neuss, Germany, 41469
    - Teva Investigational Site 32839
  - Peine, Germany, 31224
    - Teva Investigational Site 32836
  - Wiesbaden, Germany, 65189
    - Teva Investigational Site 32849
  - Witten, Germany, 58452
    - Teva Investigational Site 32852
Greece
- - Athens, Greece, 10675
    - Teva Investigational Site 63086
  - Evros, Greece, 68100
    - Teva Investigational Site 63085
  - Heraklion, Greece, 71500
    - Teva Investigational Site 63089
  - Larissa, Greece, 41 110
    - Teva Investigational Site 63087
  - Thessaloniki, Greece, 57 010
    - Teva Investigational Site 63083
  - Thessaloniki, Greece, 54639
    - Teva Investigational Site 63082
  - Thivon and Livadias, Greece, 11527
    - Teva Investigational Site 63088
Hungary
- - Budapest, Hungary, 1027
    - Teva Investigational Site 51346
  - Budapest, Hungary, 1033
    - Teva Investigational Site 51344
  - Budapest, Hungary, 1094
    - Teva Investigational Site 51340
  - Debrecen, Hungary, 4027
    - Teva Investigational Site 51342
  - Mosonmagyaróvár, Hungary, 9200
    - Teva Investigational Site 51345
  - Pécs, Hungary, 7635
    - Teva Investigational Site 51343
  - Szeged, Hungary, 6720
    - Teva Investigational Site 51339
  - Szigetvár, Hungary, 7900
    - Teva Investigational Site 51341
Israel
- - Ashkelon, Israel, 7830604
    - Teva Investigational Site 80196
  - Beersheba, Israel, 8457108
    - Teva Investigational Site 80201
  - Haifa, Israel, 3109601
    - Teva Investigational Site 80200
  - Jerusalem, Israel, 9103102
    - Teva Investigational Site 80194
  - Jerusalem, Israel, 9112010
    - Teva Investigational Site 80198
  - Petach Tikvah, Israel, 4920235
    - Teva Investigational Site 80199
  - Petah Tikva, Israel, 4941492
    - Teva Investigational Site 80195
  - Rehovot, Israel, 7661041
    - Teva Investigational Site 80193
  - Tel Aviv, Israel, 6423906
    - Teva Investigational Site 80197
Italy
- - Ferrara, Italy, 44124
    - Teva Investigational Site 30306
  - Padova, Italy, 35128
    - Teva Investigational Site 30316
  - Pisa, Italy, 56126
    - Teva Investigational Site 30317
  - Verona, Italy, 37134
    - Teva Investigational Site 30307
  - Verona, Italy, 37131
    - Teva Investigational Site 30318
Latvia
- - Balvi, Latvia, LV-4501
    - Teva Investigational Site 56016
  - Daugavpils, Latvia, LV-5417
    - Teva Investigational Site 56019
  - Jūrmala, Latvia, LV-2015
    - Teva Investigational Site 56017
  - Riga, Latvia, 1004
    - Teva Investigational Site 56014
  - Riga, Latvia, LV-1003
    - Teva Investigational Site 56013
  - Riga, Latvia, LV1010
    - Teva Investigational Site 56018
  - Riga, Latvia, LV-1004
    - Teva Investigational Site 56020
  - Rēzekne, Latvia, 4601
    - Teva Investigational Site 56015
Mexico
- - Chihuahua City, Mexico, 31203
    - Teva Investigational Site 21125
  - Guadalajara, Mexico, 44100
    - Teva Investigational Site 21122
  - Guadalajara, Mexico, 44670
    - Teva Investigational Site 21127
  - Monterrey, Mexico, 64460
    - Teva Investigational Site 21126
  - Oaxaca City, Mexico, 68000
    - Teva Investigational Site 21123
  - Villahermosa, Mexico, 86035
    - Teva Investigational Site 21129
New Zealand
- - Auckland, New Zealand, 1010
    - Teva Investigational Site 79054
  - Auckland, New Zealand, 626
    - Teva Investigational Site 79056
  - Christchurch, New Zealand, 8013
    - Teva Investigational Site 79055
  - Dunedin, New Zealand, 9016
    - Teva Investigational Site 79057
  - Hamilton, New Zealand, 3204
    - Teva Investigational Site 79051
  - Nawton, New Zealand, 3200
    - Teva Investigational Site 79062
  - Nelson, New Zealand, 7011
    - Teva Investigational Site 79061
  - Rotorua, New Zealand, 3010
    - Teva Investigational Site 79059
  - South Hastings, New Zealand, 4122
    - Teva Investigational Site 79060
  - Tauranga, New Zealand, 3110
    - Teva Investigational Site 79052
  - Waikanae Beach, New Zealand, 5036
    - Teva Investigational Site 79058
  - Wellington, New Zealand, 6021
    - Teva Investigational Site 79050
Poland
- - Bialystok, Poland, 15-010
    - Teva Investigational Site 53531
  - Bialystok, Poland, 15-430
    - Teva Investigational Site 53527
  - Bydgoszcz, Poland, 85-796
    - Teva Investigational Site 53534
  - Elblag, Poland, 82-300
    - Teva Investigational Site 53537
  - Gdansk, Poland, 80-214
    - Teva Investigational Site 53524
  - Gdansk, Poland, 80-344
    - Teva Investigational Site 53538
  - Krakow, Poland, 31-141
    - Teva Investigational Site 53530
  - Krakow, Poland, 31-624
    - Teva Investigational Site 53521
  - Lodz, Poland, 93-513
    - Teva Investigational Site 53528
  - Lublin, Poland, 20-089
    - Teva Investigational Site 53523
  - Lublin, Poland, 20-095
    - Teva Investigational Site 53533
  - Maków Podhalański, Poland, 34-220
    - Teva Investigational Site 53522
  - Ostrowiec Świętokrzyski, Poland, 27-400
    - Teva Investigational Site 53525
  - Poznan, Poland, 60-693
    - Teva Investigational Site 53532
  - Rzeszów, Poland, 35-051
    - Teva Investigational Site 53526
  - Skierniewice, Poland, 96-100
    - Teva Investigational Site 53536
  - Warsaw, Poland, 00-632
    - Teva Investigational Site 53535
  - Zawadzkie, Poland, 47-120
    - Teva Investigational Site 53529
Romania
- - Bacau, Romania, 600625
    - Teva Investigational Site 52139
  - Bragadiru, Romania, 769764
    - Teva Investigational Site 52140
  - Bucharest, Romania, 12052
    - Teva Investigational Site 52138
  - Bucharest, Romania, 41507
    - Teva Investigational Site 52136
  - Cluj-Napoca, Romania, 400371
    - Teva Investigational Site 52135
  - Craiova, Romania, 200515
    - Teva Investigational Site 52137
Serbia
- - Belgrade, Serbia, 11000
    - Teva Investigational Site 61071
  - Belgrade, Serbia, 11000
    - Teva Investigational Site 61075
  - Belgrade, Serbia, 11070
    - Teva Investigational Site 61076
  - Belgrade, Serbia, 11000
    - Teva Investigational Site 61073
  - Belgrade, Serbia, 11000
    - Teva Investigational Site 61074
  - Belgrade, Serbia, 11000
    - Teva Investigational Site 61080
  - Belgrade, Serbia, 11080
    - Teva Investigational Site 61077
  - Kamenitz, Serbia, 21204
    - Teva Investigational Site 61072
  - Kragujevac, Serbia, 34000
    - Teva Investigational Site 61078
  - Niš, Serbia, 18000
    - Teva Investigational Site 61070
  - Novi Sad, Serbia, 21000
    - Teva Investigational Site 61079
Slovakia
- - Bardejov, Slovakia, 08501
    - Teva Investigational Site 62083
  - Košice, Slovakia, 040 11
    - Teva Investigational Site 62082
  - Rimavská Sobota, Slovakia, 979 01
    - Teva Investigational Site 62080
  - Slovakia, Slovakia, 06224
    - Teva Investigational Site 62077
  - Spišská Nová Ves, Slovakia, 052 01
    - Teva Investigational Site 62078
  - Žilina, Slovakia, 01001
    - Teva Investigational Site 62079
  - Žilina, Slovakia, 1001
    - Teva Investigational Site 62081
South Africa
- - Benoni, South Africa, 1501
    - Teva Investigational Site 90078
  - Cape Town, South Africa, 7530
    - Teva Investigational Site 90069
  - Cape Town, South Africa, 7530
    - Teva Investigational Site 90077
  - Cape Town, South Africa, 7700
    - Teva Investigational Site 90079
  - Cape Town, South Africa, 7570
    - Teva Investigational Site 90063
  - Chatsworth, South Africa, 4092
    - Teva Investigational Site 90073
  - Durban, South Africa, 4092
    - Teva Investigational Site 90067
  - Ennerdale, South Africa, 1830
    - Teva Investigational Site 90070
  - Germiston, South Africa, 1401
    - Teva Investigational Site 90083
  - Johannesburg, South Africa, 2113
    - Teva Investigational Site 90062
  - Krugersdorp, South Africa, 1739
    - Teva Investigational Site 90074
  - KwaDukuza, South Africa, 4450
    - Teva Investigational Site 90065
  - Middelburg, South Africa, 1050
    - Teva Investigational Site 90064
  - Midrand, South Africa, 1685
    - Teva Investigational Site 90072
  - Plettenberg Bay, South Africa, 6600
    - Teva Investigational Site 90071
  - Polokwane, South Africa, 699
    - Teva Investigational Site 90081
  - Pretoria, South Africa, 0181
    - Teva Investigational Site 90076
  - Raslouw, South Africa, 0157
    - Teva Investigational Site 90080
  - Roodepoort, South Africa, 1724
    - Teva Investigational Site 90068
  - Somerset West, South Africa, 7130
    - Teva Investigational Site 90066
  - Soweto, South Africa, 1868
    - Teva Investigational Site 90082
South Korea
- - Seoul, South Korea, 04763
    - Teva Investigational Site 87039
  - Seoul, South Korea, 1757
    - Teva Investigational Site 87044
  - Seoul, South Korea, 3312
    - Teva Investigational Site 87043
  - Seoul, South Korea, 3722
    - Teva Investigational Site 87042
  - Seoul, South Korea, 5505
    - Teva Investigational Site 87040
  - Seoul, South Korea, 6591
    - Teva Investigational Site 87041
Spain
- - Badalona, Spain, 8916
    - Teva Investigational Site 31304
  - Barcelona, Spain, 08017
    - Teva Investigational Site 31305
  - Barcelona, Spain, 08035
    - Teva Investigational Site 31307
  - Córdoba, Spain, 14004
    - Teva Investigational Site 31309
  - Madrid, Spain, 28007
    - Teva Investigational Site 31303
  - Sabadell, Spain, 8208
    - Teva Investigational Site 31310
  - Santiago de Compostela, Spain, 15706
    - Teva Investigational Site 31306
  - Seville, Spain, 41013
    - Teva Investigational Site 31311
  - Valencia, Spain, 46015
    - Teva Investigational Site 31308
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Teva Investigational Site 15706
  - Birmingham, Alabama, United States, 35233
    - Teva Investigational Site 15786
  - Dothan, Alabama, United States, 36305
    - Teva Investigational Site 15768
- Arizona
  - Paradise Valley, Arizona, United States, 85258
    - Teva Investigational Site 15581
  - Scottsdale, Arizona, United States, 85259
    - Teva Investigational Site 15710
  - Tucson, Arizona, United States, 85741
    - Teva Investigational Site 15661
- California
  - Bakersfield, California, United States, 93301
    - Teva Investigational Site 15685
  - Fresno, California, United States, 93704
    - Teva Investigational Site 15721
  - Huntington Beach, California, United States, 92647-6853
    - Teva Investigational Site 15788
  - La Jolla, California, United States, 92037
    - Teva Investigational Site 15720
  - La Palma, California, United States, 90623
    - Teva Investigational Site 15687
  - Long Beach, California, United States, 90806-2613
    - Teva Investigational Site 15708
  - Long Beach, California, United States, 90815
    - Teva Investigational Site 15712
  - Los Angeles, California, United States, 90025
    - Teva Investigational Site 15643
  - Napa, California, United States, 94558
    - Teva Investigational Site 15695
  - Northridge, California, United States, 91324
    - Teva Investigational Site 15692
  - Redondo Beach, California, United States, 90277-5720
    - Teva Investigational Site 15682
  - San Bernardino, California, United States, 92408
    - Teva Investigational Site 15629
  - San Diego, California, United States, 92120
    - Teva Investigational Site 15709
  - San Jose, California, United States, 95117
    - Teva Investigational Site 15704
  - Stockton, California, United States, 95207
    - Teva Investigational Site 15620
  - Westminster, California, United States, 92683
    - Teva Investigational Site 15621
- Colorado
  - Aurora, Colorado, United States, 80014
    - Teva Investigational Site 15612
  - Colorado Springs, Colorado, United States, 80907
    - Teva Investigational Site 15588
  - Colorado Springs, Colorado, United States, 80922
    - Teva Investigational Site 15765
  - Englewood, Colorado, United States, 80110
    - Teva Investigational Site 15676
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20009
    - Teva Investigational Site 15781
- Florida
  - Aventura, Florida, United States, 33180
    - Teva Investigational Site 15660
  - Cape Coral, Florida, United States, 33914
    - Teva Investigational Site 15624
  - Cutler Bay, Florida, United States, 33189
    - Teva Investigational Site 15598
  - Doral, Florida, United States, 33122
    - Teva Investigational Site 15776
  - Greenacres City, Florida, United States, 33476
    - Teva Investigational Site 15579
  - Hialeah, Florida, United States, 33012
    - Teva Investigational Site 15582
  - Hialeah, Florida, United States, 33012
    - Teva Investigational Site 15664
  - Homestead, Florida, United States, 33030
    - Teva Investigational Site 15657
  - Jacksonville, Florida, United States, 32207
    - Teva Investigational Site 15713
  - Leesburg, Florida, United States, 34748
    - Teva Investigational Site 15632
  - Margate, Florida, United States, 33063
    - Teva Investigational Site 15777
  - Miami, Florida, United States, 33126
    - Teva Investigational Site 15602
  - Miami, Florida, United States, 33126
    - Teva Investigational Site 15722
  - Miami, Florida, United States, 33126
    - Teva Investigational Site 15724
  - Miami, Florida, United States, 33130
    - Teva Investigational Site 15655
  - Miami, Florida, United States, 33142-2946
    - Teva Investigational Site 15605
  - Miami, Florida, United States, 33143
    - Teva Investigational Site 15634
  - Miami, Florida, United States, 33144
    - Teva Investigational Site 15596
  - Miami, Florida, United States, 33144
    - Teva Investigational Site 15654
  - Miami, Florida, United States, 33155
    - Teva Investigational Site 15773
  - Miami, Florida, United States, 33173
    - Teva Investigational Site 15585
  - Miami, Florida, United States, 33173
    - Teva Investigational Site 15639
  - Miami, Florida, United States, 33173
    - Teva Investigational Site 15645
  - Miami, Florida, United States, 33175
    - Teva Investigational Site 15772
  - Miami, Florida, United States, 33176
    - Teva Investigational Site 15592
  - Miami, Florida, United States, 33176
    - Teva Investigational Site 15769
  - Miami, Florida, United States, 33186
    - Teva Investigational Site 15644
  - Miami Lakes, Florida, United States, 33014
    - Teva Investigational Site 15589
  - Miami Lakes, Florida, United States, 33014
    - Teva Investigational Site 15599
  - Miami Lakes, Florida, United States, 33016
    - Teva Investigational Site 15595
  - Oldsmar, Florida, United States, 34677
    - Teva Investigational Site 15665
  - Orlando, Florida, United States, 32806
    - Teva Investigational Site 15659
  - Orlando, Florida, United States, 32819
    - Teva Investigational Site 15617
  - Orlando, Florida, United States, 32825
    - Teva Investigational Site 15625
  - Pembroke Pines, Florida, United States, 33025
    - Teva Investigational Site 15597
  - Sweetwater, Florida, United States, 33182
    - Teva Investigational Site 15767
  - Tamarac, Florida, United States, 33321
    - Teva Investigational Site 15587
  - Tampa, Florida, United States, 33604
    - Teva Investigational Site 15611
  - Tampa, Florida, United States, 33607-6327
    - Teva Investigational Site 15619
  - Tampa, Florida, United States, 33607
    - Teva Investigational Site 15653
  - Virginia Gardens, Florida, United States, 33166
    - Teva Investigational Site 15652
  - Winter Park, Florida, United States, 32789
    - Teva Investigational Site 15606
- Georgia
  - Atlanta, Georgia, United States, 30329
    - Teva Investigational Site 15717
  - Conyers, Georgia, United States, 30012
    - Teva Investigational Site 15711
  - Savannah, Georgia, United States, 31406-2668
    - Teva Investigational Site 15626
- Idaho
  - Boise, Idaho, United States, 83706
    - Teva Investigational Site 15604
- Illinois
  - Chicago, Illinois, United States, 60607
    - Teva Investigational Site 15669
  - Chicago, Illinois, United States, 60612
    - Teva Investigational Site 15616
  - Chicago, Illinois, United States, 60637
    - Teva Investigational Site 15716
  - Skokie, Illinois, United States, 60077
    - Teva Investigational Site 15600
- Indiana
  - Evansville, Indiana, United States, 47715
    - Teva Investigational Site 15674
- Kansas
  - Overland Park, Kansas, United States, 66210
    - Teva Investigational Site 15580
- Kentucky
  - Lexington, Kentucky, United States, 40509
    - Teva Investigational Site 15627
- Louisiana
  - Lafayette, Louisiana, United States, 70508
    - Teva Investigational Site 15770
- Maine
  - Bangor, Maine, United States, 04401
    - Teva Investigational Site 15667
- Maryland
  - Rockville, Maryland, United States, 20852
    - Teva Investigational Site 15689
  - White Marsh, Maryland, United States, 21162
    - Teva Investigational Site 15583
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Teva Investigational Site 15628
  - Fall River, Massachusetts, United States, 02723
    - Teva Investigational Site 15686
  - North Dartmouth, Massachusetts, United States, 02747
    - Teva Investigational Site 15663
  - South Dartmouth, Massachusetts, United States, 02747
    - Teva Investigational Site 15764
- Michigan
  - Detroit, Michigan, United States, 48202
    - Teva Investigational Site 15702
  - Flint, Michigan, United States, 48507
    - Teva Investigational Site 15701
  - Ypsilanti, Michigan, United States, 48197
    - Teva Investigational Site 15593
- Missouri
  - Kansas City, Missouri, United States, 66160
    - Teva Investigational Site 15648
  - St Louis, Missouri, United States, 63110
    - Teva Investigational Site 15640
  - St Louis, Missouri, United States, 63123
    - Teva Investigational Site 15650
  - St Louis, Missouri, United States, 63141-7068
    - Teva Investigational Site 15633
- Nebraska
  - Hastings, Nebraska, United States, 68901
    - Teva Investigational Site 15790
- Nevada
  - Las Vegas, Nevada, United States, 89123-2875
    - Teva Investigational Site 15679
- New Jersey
  - North Bergen, New Jersey, United States, 07047
    - Teva Investigational Site 15725
- New York
  - Hawthorne, New York, United States, 10532
    - Teva Investigational Site 15688
  - Horseheads, New York, United States, 14845
    - Teva Investigational Site 15603
  - Hyde Park, New York, United States, 11042
    - Teva Investigational Site 15666
  - New Windsor, New York, United States, 12553
    - Teva Investigational Site 15675
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Teva Investigational Site 15618
  - Chapel Hill, North Carolina, United States, 27599
    - Teva Investigational Site 15601
  - Charlotte, North Carolina, United States, 28277
    - Teva Investigational Site 15697
  - Elizabeth City, North Carolina, United States, 27909-3465
    - Teva Investigational Site 15610
  - High Point, North Carolina, United States, 27260
    - Teva Investigational Site 15651
  - Statesville, North Carolina, United States, 28625
    - Teva Investigational Site 15771
  - Wilmington, North Carolina, United States, 28401
    - Teva Investigational Site 15631
  - Winston-Salem, North Carolina, United States, 27157
    - Teva Investigational Site 15584
- Ohio
  - Cincinnati, Ohio, United States, 45236
    - Teva Investigational Site 15607
  - Columbus, Ohio, United States, 43205
    - Teva Investigational Site 15613
  - Dayton, Ohio, United States, 45404
    - Teva Investigational Site 15784
  - Dayton, Ohio, United States, 45429
    - Teva Investigational Site 15791
  - Toledo, Ohio, United States, 43617
    - Teva Investigational Site 15662
  - Toledo, Ohio, United States, 43606
    - Teva Investigational Site 15780
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120-9389
    - Teva Investigational Site 15577
  - Tulsa, Oklahoma, United States, 74133
    - Teva Investigational Site 15594
  - Yukon, Oklahoma, United States, 73099
    - Teva Investigational Site 15775
- Oregon
  - Grants Pass, Oregon, United States, 97527
    - Teva Investigational Site 15646
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19140
    - Teva Investigational Site 15642
  - Pittsburgh, Pennsylvania, United States, 15241
    - Teva Investigational Site 15576
- South Carolina
  - North Charleston, South Carolina, United States, 29420
    - Teva Investigational Site 15608
  - Rock Hill, South Carolina, United States, 29732
    - Teva Investigational Site 15672
- Tennessee
  - Knoxville, Tennessee, United States, 37909
    - Teva Investigational Site 15691
- Texas
  - Austin, Texas, United States, 78759
    - Teva Investigational Site 15705
  - Boerne, Texas, United States, 78006
    - Teva Investigational Site 15641
  - Brownsville, Texas, United States, 78520
    - Teva Investigational Site 15778
  - Corsicana, Texas, United States, 75110
    - Teva Investigational Site 15668
  - Dallas, Texas, United States, 75209
    - Teva Investigational Site 15658
  - Dallas, Texas, United States, 75231-8206
    - Teva Investigational Site 15637
  - Dallas, Texas, United States, 75235
    - Teva Investigational Site 15623
  - Edinburg, Texas, United States, 78539
    - Teva Investigational Site 15785
  - El Paso, Texas, United States, 79902
    - Teva Investigational Site 15678
  - El Paso, Texas, United States, 79902
    - Teva Investigational Site 15787
  - El Paso, Texas, United States, 79912
    - Teva Investigational Site 15591
  - Houston, Texas, United States, 77008
    - Teva Investigational Site 15696
  - Houston, Texas, United States, 77074-2005
    - Teva Investigational Site 15614
  - Houston, Texas, United States, 77099
    - Teva Investigational Site 15578
  - Houston, Texas, United States, 77030
    - Teva Investigational Site 15714
  - Houston, Texas, United States, 77065
    - Teva Investigational Site 15680
  - Katy, Texas, United States, 77494
    - Teva Investigational Site 15690
  - Kerrville, Texas, United States, 78028
    - Teva Investigational Site 15684
  - McKinney, Texas, United States, 75069
    - Teva Investigational Site 15630
  - San Antonio, Texas, United States, 78229
    - Teva Investigational Site 15670
  - San Antonio, Texas, United States, 78258
    - Teva Investigational Site 15638
  - San Antonio, Texas, United States, 78212
    - Teva Investigational Site 15656
  - Sherman, Texas, United States, 75090
    - Teva Investigational Site 15647
  - Splendora, Texas, United States, 77372
    - Teva Investigational Site 15673
  - Tomball, Texas, United States, 77081
    - Teva Investigational Site 15707
  - Victoria, Texas, United States, 77901
    - Teva Investigational Site 15693
  - Waxahachie, Texas, United States, 75165-1430
    - Teva Investigational Site 15649
- Utah
  - Bountiful, Utah, United States, 84010
    - Teva Investigational Site 15671
  - Sandy City, Utah, United States, 84093
    - Teva Investigational Site 15635
  - West Valley City, Utah, United States, 84119
    - Teva Investigational Site 15789
- Virginia
  - Williamsburg, Virginia, United States, 23188
    - Teva Investigational Site 15683
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228
    - Teva Investigational Site 15586

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

Child
Adult
Older Adult

Accepts Healthy Volunteers

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

Number of Arms

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
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
Time to first severe CAE with Low Dose (LD) Fp/ABS eMDPI 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
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
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

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)

October 31, 2026

Study Completion (Estimated)

October 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)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

FpA-AS-30094
2023-505435-12-00 (Other Identifier: EUCT)

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

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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