A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
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
2 other identifiers
interventional
2,700
22 countries
393
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Aug 2023
Longer than P75 for phase_3 asthma
393 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2023
CompletedFirst Submitted
Initial submission to the registry
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
May 4, 2026
April 1, 2026
3.2 years
September 18, 2023
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI
Up to 42 months
Secondary Outcomes (8)
Time to first severe CAE with Low Dose (LD) Fp/ABS eMDPI
Up to 42 months
Annualized Severe CAE Rate
Up to 42 months
Total Annualized SCS Exposure Over the Treatment Period
Up to 42 months
Asthma Control Questionnaire-5 (ACQ-5) Response
Baseline, Week 24
Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)
Baseline, Week 24
- +3 more secondary outcomes
Study Arms (3)
TEV-56248 Low Dose
EXPERIMENTALInhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
TEV-56248 High Dose
EXPERIMENTALInhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Albuterol sulfate
ACTIVE COMPARATORInhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Interventions
Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (393)
Teva Investigational Site 15706
Birmingham, Alabama, 35209, United States
Teva Investigational Site 15786
Birmingham, Alabama, 35233, United States
Teva Investigational Site 15768
Dothan, Alabama, 36305, United States
Teva Investigational Site 15581
Paradise Valley, Arizona, 85258, United States
Teva Investigational Site 15710
Scottsdale, Arizona, 85259, United States
Teva Investigational Site 15661
Tucson, Arizona, 85741, United States
Teva Investigational Site 15685
Bakersfield, California, 93301, United States
Teva Investigational Site 15721
Fresno, California, 93704, United States
Teva Investigational Site 15788
Huntington Beach, California, 92647-6853, United States
Teva Investigational Site 15720
La Jolla, California, 92037, United States
Teva Investigational Site 15687
La Palma, California, 90623, United States
Teva Investigational Site 15708
Long Beach, California, 90806-2613, United States
Teva Investigational Site 15712
Long Beach, California, 90815, United States
Teva Investigational Site 15643
Los Angeles, California, 90025, United States
Teva Investigational Site 15695
Napa, California, 94558, United States
Teva Investigational Site 15692
Northridge, California, 91324, United States
Teva Investigational Site 15682
Redondo Beach, California, 90277-5720, United States
Teva Investigational Site 15629
San Bernardino, California, 92408, United States
Teva Investigational Site 15709
San Diego, California, 92120, United States
Teva Investigational Site 15704
San Jose, California, 95117, United States
Teva Investigational Site 15620
Stockton, California, 95207, United States
Teva Investigational Site 15621
Westminster, California, 92683, United States
Teva Investigational Site 15612
Aurora, Colorado, 80014, United States
Teva Investigational Site 15588
Colorado Springs, Colorado, 80907, United States
Teva Investigational Site 15765
Colorado Springs, Colorado, 80922, United States
Teva Investigational Site 15676
Englewood, Colorado, 80110, United States
Teva Investigational Site 15781
Washington D.C., District of Columbia, 20009, United States
Teva Investigational Site 15660
Aventura, Florida, 33180, United States
Teva Investigational Site 15624
Cape Coral, Florida, 33914, United States
Teva Investigational Site 15598
Cutler Bay, Florida, 33189, United States
Teva Investigational Site 15776
Doral, Florida, 33122, United States
Teva Investigational Site 15579
Greenacres City, Florida, 33476, United States
Teva Investigational Site 15582
Hialeah, Florida, 33012, United States
Teva Investigational Site 15664
Hialeah, Florida, 33012, United States
Teva Investigational Site 15657
Homestead, Florida, 33030, United States
Teva Investigational Site 15713
Jacksonville, Florida, 32207, United States
Teva Investigational Site 15632
Leesburg, Florida, 34748, United States
Teva Investigational Site 15777
Margate, Florida, 33063, United States
Teva Investigational Site 15602
Miami, Florida, 33126, United States
Teva Investigational Site 15722
Miami, Florida, 33126, United States
Teva Investigational Site 15724
Miami, Florida, 33126, United States
Teva Investigational Site 15655
Miami, Florida, 33130, United States
Teva Investigational Site 15605
Miami, Florida, 33142-2946, United States
Teva Investigational Site 15634
Miami, Florida, 33143, United States
Teva Investigational Site 15596
Miami, Florida, 33144, United States
Teva Investigational Site 15654
Miami, Florida, 33144, United States
Teva Investigational Site 15773
Miami, Florida, 33155, United States
Teva Investigational Site 15585
Miami, Florida, 33173, United States
Teva Investigational Site 15639
Miami, Florida, 33173, United States
Teva Investigational Site 15645
Miami, Florida, 33173, United States
Teva Investigational Site 15772
Miami, Florida, 33175, United States
Teva Investigational Site 15592
Miami, Florida, 33176, United States
Teva Investigational Site 15769
Miami, Florida, 33176, United States
Teva Investigational Site 15644
Miami, Florida, 33186, United States
Teva Investigational Site 15589
Miami Lakes, Florida, 33014, United States
Teva Investigational Site 15599
Miami Lakes, Florida, 33014, United States
Teva Investigational Site 15595
Miami Lakes, Florida, 33016, United States
Teva Investigational Site 15665
Oldsmar, Florida, 34677, United States
Teva Investigational Site 15659
Orlando, Florida, 32806, United States
Teva Investigational Site 15617
Orlando, Florida, 32819, United States
Teva Investigational Site 15625
Orlando, Florida, 32825, United States
Teva Investigational Site 15597
Pembroke Pines, Florida, 33025, United States
Teva Investigational Site 15767
Sweetwater, Florida, 33182, United States
Teva Investigational Site 15587
Tamarac, Florida, 33321, United States
Teva Investigational Site 15611
Tampa, Florida, 33604, United States
Teva Investigational Site 15619
Tampa, Florida, 33607-6327, United States
Teva Investigational Site 15653
Tampa, Florida, 33607, United States
Teva Investigational Site 15652
Virginia Gardens, Florida, 33166, United States
Teva Investigational Site 15606
Winter Park, Florida, 32789, United States
Teva Investigational Site 15717
Atlanta, Georgia, 30329, United States
Teva Investigational Site 15711
Conyers, Georgia, 30012, United States
Teva Investigational Site 15626
Savannah, Georgia, 31406-2668, United States
Teva Investigational Site 15604
Boise, Idaho, 83706, United States
Teva Investigational Site 15669
Chicago, Illinois, 60607, United States
Teva Investigational Site 15616
Chicago, Illinois, 60612, United States
Teva Investigational Site 15716
Chicago, Illinois, 60637, United States
Teva Investigational Site 15600
Skokie, Illinois, 60077, United States
Teva Investigational Site 15674
Evansville, Indiana, 47715, United States
Teva Investigational Site 15580
Overland Park, Kansas, 66210, United States
Teva Investigational Site 15627
Lexington, Kentucky, 40509, United States
Teva Investigational Site 15770
Lafayette, Louisiana, 70508, United States
Teva Investigational Site 15667
Bangor, Maine, 04401, United States
Teva Investigational Site 15689
Rockville, Maryland, 20852, United States
Teva Investigational Site 15583
White Marsh, Maryland, 21162, United States
Teva Investigational Site 15628
Boston, Massachusetts, 02115, United States
Teva Investigational Site 15686
Fall River, Massachusetts, 02723, United States
Teva Investigational Site 15663
North Dartmouth, Massachusetts, 02747, United States
Teva Investigational Site 15764
South Dartmouth, Massachusetts, 02747, United States
Teva Investigational Site 15702
Detroit, Michigan, 48202, United States
Teva Investigational Site 15701
Flint, Michigan, 48507, United States
Teva Investigational Site 15593
Ypsilanti, Michigan, 48197, United States
Teva Investigational Site 15648
Kansas City, Missouri, 66160, United States
Teva Investigational Site 15640
St Louis, Missouri, 63110, United States
Teva Investigational Site 15650
St Louis, Missouri, 63123, United States
Teva Investigational Site 15633
St Louis, Missouri, 63141-7068, United States
Teva Investigational Site 15790
Hastings, Nebraska, 68901, United States
Teva Investigational Site 15679
Las Vegas, Nevada, 89123-2875, United States
Teva Investigational Site 15725
North Bergen, New Jersey, 07047, United States
Teva Investigational Site 15688
Hawthorne, New York, 10532, United States
Teva Investigational Site 15603
Horseheads, New York, 14845, United States
Teva Investigational Site 15666
Hyde Park, New York, 11042, United States
Teva Investigational Site 15675
New Windsor, New York, 12553, United States
Teva Investigational Site 15618
Asheville, North Carolina, 28803, United States
Teva Investigational Site 15601
Chapel Hill, North Carolina, 27599, United States
Teva Investigational Site 15697
Charlotte, North Carolina, 28277, United States
Teva Investigational Site 15610
Elizabeth City, North Carolina, 27909-3465, United States
Teva Investigational Site 15651
High Point, North Carolina, 27260, United States
Teva Investigational Site 15771
Statesville, North Carolina, 28625, United States
Teva Investigational Site 15631
Wilmington, North Carolina, 28401, United States
Teva Investigational Site 15584
Winston-Salem, North Carolina, 27157, United States
Teva Investigational Site 15607
Cincinnati, Ohio, 45236, United States
Teva Investigational Site 15613
Columbus, Ohio, 43205, United States
Teva Investigational Site 15784
Dayton, Ohio, 45404, United States
Teva Investigational Site 15791
Dayton, Ohio, 45429, United States
Teva Investigational Site 15780
Toledo, Ohio, 43606, United States
Teva Investigational Site 15662
Toledo, Ohio, 43617, United States
Teva Investigational Site 15577
Oklahoma City, Oklahoma, 73120-9389, United States
Teva Investigational Site 15594
Tulsa, Oklahoma, 74133, United States
Teva Investigational Site 15775
Yukon, Oklahoma, 73099, United States
Teva Investigational Site 15646
Grants Pass, Oregon, 97527, United States
Teva Investigational Site 15642
Philadelphia, Pennsylvania, 19140, United States
Teva Investigational Site 15576
Pittsburgh, Pennsylvania, 15241, United States
Teva Investigational Site 15608
North Charleston, South Carolina, 29420, United States
Teva Investigational Site 15672
Rock Hill, South Carolina, 29732, United States
Teva Investigational Site 15691
Knoxville, Tennessee, 37909, United States
Teva Investigational Site 15705
Austin, Texas, 78759, United States
Teva Investigational Site 15641
Boerne, Texas, 78006, United States
Teva Investigational Site 15778
Brownsville, Texas, 78520, United States
Teva Investigational Site 15668
Corsicana, Texas, 75110, United States
Teva Investigational Site 15658
Dallas, Texas, 75209, United States
Teva Investigational Site 15637
Dallas, Texas, 75231-8206, United States
Teva Investigational Site 15623
Dallas, Texas, 75235, United States
Teva Investigational Site 15785
Edinburg, Texas, 78539, United States
Teva Investigational Site 15678
El Paso, Texas, 79902, United States
Teva Investigational Site 15787
El Paso, Texas, 79902, United States
Teva Investigational Site 15591
El Paso, Texas, 79912, United States
Teva Investigational Site 15696
Houston, Texas, 77008, United States
Teva Investigational Site 15714
Houston, Texas, 77030, United States
Teva Investigational Site 15680
Houston, Texas, 77065, United States
Teva Investigational Site 15614
Houston, Texas, 77074-2005, United States
Teva Investigational Site 15578
Houston, Texas, 77099, United States
Teva Investigational Site 15690
Katy, Texas, 77494, United States
Teva Investigational Site 15684
Kerrville, Texas, 78028, United States
Teva Investigational Site 15630
McKinney, Texas, 75069, United States
Teva Investigational Site 15656
San Antonio, Texas, 78212, United States
Teva Investigational Site 15670
San Antonio, Texas, 78229, United States
Teva Investigational Site 15638
San Antonio, Texas, 78258, United States
Teva Investigational Site 15647
Sherman, Texas, 75090, United States
Teva Investigational Site 15673
Splendora, Texas, 77372, United States
Teva Investigational Site 15707
Tomball, Texas, 77081, United States
Teva Investigational Site 15693
Victoria, Texas, 77901, United States
Teva Investigational Site 15649
Waxahachie, Texas, 75165-1430, United States
Teva Investigational Site 15671
Bountiful, Utah, 84010, United States
Teva Investigational Site 15635
Sandy City, Utah, 84093, United States
Teva Investigational Site 15789
West Valley City, Utah, 84119, United States
Teva Investigational Site 15683
Williamsburg, Virginia, 23188, United States
Teva Investigational Site 15586
Greenfield, Wisconsin, 53228, United States
Teva Investigational Site 20126
Bahía Blanca, B8000JRB, Argentina
Teva Investigational Site 20130
Bahía Blanca, B8001AAD, Argentina
Teva Investigational Site 20109
Bahía Blanca, B8001DDU, Argentina
Teva Investigational Site 20113
Buenos Aires, C1121ABE, Argentina
Teva Investigational Site 20135
Buenos Aires, C1128AAF, Argentina
Teva Investigational Site 20111
Buenos Aires, C1426ABP, Argentina
Teva Investigational Site 20138
Buenos Aires, C1426ABP, Argentina
Teva Investigational Site 20117
Buenos Aires Province, 7600, Argentina
Teva Investigational Site 20128
CABA, 1414, Argentina
Teva Investigational Site 20139
CABA, C1426ABP, Argentina
Teva Investigational Site 20129
CapitalFederal, C1425BEN, Argentina
Teva Investigational Site 20118
Concepción del Uruguay, 3260, Argentina
Teva Investigational Site 20106
Córdoba, X5003DCE, Argentina
Teva Investigational Site 20125
Florida, Vicente Lopez, B1602DQD, Argentina
Teva Investigational Site 20136
Godoy Cruz, 5501, Argentina
Teva Investigational Site 20122
Lanús Este, 1824, Argentina
Teva Investigational Site 20107
Lobos, B7240KJB, Argentina
Teva Investigational Site 20123
Mar del Plata, B7612ENA, Argentina
Teva Investigational Site 20121
Mendoza, 5500, Argentina
Teva Investigational Site 20115
Mendoza, M55000CBA, Argentina
Teva Investigational Site 20110
Mendoza, M5500CCA, Argentina
Teva Investigational Site 20127
Mendoza, M5507XAF, Argentina
Teva Investigational Site 20140
Paraná, E3100XAI, Argentina
Teva Investigational Site 20112
Quilmes, 1878, Argentina
Teva Investigational Site 20119
Rosario, 2000, Argentina
Teva Investigational Site 20105
Rosario, S2000 DEJ, Argentina
Teva Investigational Site 20120
Rosario, S2000JKR, Argentina
Teva Investigational Site 20133
San Fernando, B1646EBJ, Argentina
Teva Investigational Site 20114
San Juan Bautista, 1888, Argentina
Teva Investigational Site 20104
San Miguel de Tucumán, 4000, Argentina
Teva Investigational Site 20124
San Miguel de Tucumán, 4000, Argentina
Teva Investigational Site 20131
San Miguel de Tucumán, 4000, Argentina
Teva Investigational Site 20137
San Miguel de Tucumán, T4000EGH, Argentina
Teva Investigational Site 20116
San Rafael, M5602GGS, Argentina
Teva Investigational Site 20132
Santa Fe, S3000ASF, Argentina
Teva Investigational Site 78131
Box Hill, 3128, Australia
Teva Investigational Site 78135
Clayton, 3168, Australia
Teva Investigational Site 78133
Melbourne, 3004, Australia
Teva Investigational Site 78132
Midland, 6056, Australia
Teva Investigational Site 78130
Nedlands, 6009, Australia
Teva Investigational Site 78134
North Adelaide, 5006, Australia
Teva Investigational Site 78128
Parkville, 3052, Australia
Teva Investigational Site 78127
South Brisbane, 4101, Australia
Teva Investigational Site 59230
Blagoevgrad, 2700, Bulgaria
Teva Investigational Site 59227
Kozloduy, 3320, Bulgaria
Teva Investigational Site 59218
Pernik, 2300, Bulgaria
Teva Investigational Site 59237
Pleven, 5800, Bulgaria
Teva Investigational Site 59222
Plovdiv, 4002, Bulgaria
Teva Investigational Site 59233
Plovdiv, 4002, Bulgaria
Teva Investigational Site 59219
Rousse, 7002, Bulgaria
Teva Investigational Site 59231
Sliven, 8800, Bulgaria
Teva Investigational Site 59224
Sofia, 1142, Bulgaria
Teva Investigational Site 59226
Sofia, 1407, Bulgaria
Teva Investigational Site 59235
Sofia, 1408, Bulgaria
Teva Investigational Site 59228
Sofia, 1421, Bulgaria
Teva Investigational Site 59234
Sofia, 1431, Bulgaria
Teva Investigational Site 59221
Sofia, 1680, Bulgaria
Teva Investigational Site 59220
Stara Zagora, 6001, Bulgaria
Teva Investigational Site 59232
Varna, 9000, Bulgaria
Teva Investigational Site 59229
Vratsa, 3001, Bulgaria
Teva Investigational Site 11267
Edmonton, Alberta, T6G2G3, Canada
Teva Investigational Site 11272
Ajax, Ontario, l1s2j5, Canada
Teva Investigational Site 11270
Etobicoke, Ontario, M9V 4B4, Canada
Teva Investigational Site 11274
Hamilton, Ontario, L8S 1G5, Canada
Teva Investigational Site 11271
Winchester, Ontario, K0C 2K0, Canada
Teva Investigational Site 11273
Windsor, Ontario, N8X 2G1, Canada
Teva Investigational Site 54231
Brandýs nad Labem-Stará Boleslav, 25001, Czechia
Teva Investigational Site 54232
Brno, 60200, Czechia
Teva Investigational Site 54229
Jihlava, 586 01, Czechia
Teva Investigational Site 54226
Jindřichův Hradec, 37701, Czechia
Teva Investigational Site 54225
Lovosice, 410 02, Czechia
Teva Investigational Site 54228
Ostrava, 70900, Czechia
Teva Investigational Site 54230
Prague, 148 00, Czechia
Teva Investigational Site 54227
Varnsdorf, 40747, Czechia
Teva Investigational Site 39099
Aalborg, 9100, Denmark
Teva Investigational Site 39100
Hvidovre, 2650, Denmark
Teva Investigational Site 39098
Vejle, 7100, Denmark
Teva Investigational Site 32846
Augsburg, 86150, Germany
Teva Investigational Site 32835
Berlin, 10119, Germany
Teva Investigational Site 32834
Berlin, 10717, Germany
Teva Investigational Site 32833
Berlin, 12159, Germany
Teva Investigational Site 32840
Cottbus, D-03050, Germany
Teva Investigational Site 32829
Darmstadt, 65283, Germany
Teva Investigational Site 32850
Delitzsch, 4509, Germany
Teva Investigational Site 32853
Essen, 45239, Germany
Teva Investigational Site 32831
Frankfurt, 60596, Germany
Teva Investigational Site 32845
Frankfurt am Main, 60596, Germany
Teva Investigational Site 32838
Hamburg, 20354, Germany
Teva Investigational Site 32827
Hamburg, 22299, Germany
Teva Investigational Site 32848
Hamburg, 22335, Germany
Teva Investigational Site 32841
Hanover, 30449, Germany
Teva Investigational Site 32851
Ibbenbueren, 49477, Germany
Teva Investigational Site 32842
Karlsruhe, D-76137, Germany
Teva Investigational Site 32844
Leipzig, 4299, Germany
Teva Investigational Site 32830
Leipzig - Nordost, 04347, Germany
Teva Investigational Site 32832
Mainz A. Rhein, 55128, Germany
Teva Investigational Site 32847
München, 80539, Germany
Teva Investigational Site 32828
München, 81241, Germany
Teva Investigational Site 32843
Neu-Isenburg, 63623, Germany
Teva Investigational Site 32839
Neuss, 41469, Germany
Teva Investigational Site 32836
Peine, 31224, Germany
Teva Investigational Site 32849
Wiesbaden, 65189, Germany
Teva Investigational Site 32852
Witten, 58452, Germany
Teva Investigational Site 63086
Athens, 10675, Greece
Teva Investigational Site 63085
Evros, 68100, Greece
Teva Investigational Site 63089
Heraklion, 71500, Greece
Teva Investigational Site 63087
Larissa, 41 110, Greece
Teva Investigational Site 63082
Thessaloniki, 54639, Greece
Teva Investigational Site 63083
Thessaloniki, 57 010, Greece
Teva Investigational Site 63088
Thivon and Livadias, 11527, Greece
Teva Investigational Site 51346
Budapest, 1027, Hungary
Teva Investigational Site 51344
Budapest, 1033, Hungary
Teva Investigational Site 51340
Budapest, 1094, Hungary
Teva Investigational Site 51342
Debrecen, 4027, Hungary
Teva Investigational Site 51345
Mosonmagyaróvár, 9200, Hungary
Teva Investigational Site 51343
Pécs, 7635, Hungary
Teva Investigational Site 51339
Szeged, 6720, Hungary
Teva Investigational Site 51341
Szigetvár, 7900, Hungary
Teva Investigational Site 80196
Ashkelon, 7830604, Israel
Teva Investigational Site 80201
Beersheba, 8457108, Israel
Teva Investigational Site 80200
Haifa, 3109601, Israel
Teva Investigational Site 80194
Jerusalem, 9103102, Israel
Teva Investigational Site 80198
Jerusalem, 9112010, Israel
Teva Investigational Site 80199
Petach Tikvah, 4920235, Israel
Teva Investigational Site 80195
Petah Tikva, 4941492, Israel
Teva Investigational Site 80193
Rehovot, 7661041, Israel
Teva Investigational Site 80197
Tel Aviv, 6423906, Israel
Teva Investigational Site 30306
Ferrara, 44124, Italy
Teva Investigational Site 30316
Padova, 35128, Italy
Teva Investigational Site 30317
Pisa, 56126, Italy
Teva Investigational Site 30318
Verona, 37131, Italy
Teva Investigational Site 30307
Verona, 37134, Italy
Teva Investigational Site 56016
Balvi, LV-4501, Latvia
Teva Investigational Site 56019
Daugavpils, LV-5417, Latvia
Teva Investigational Site 56017
Jūrmala, LV-2015, Latvia
Teva Investigational Site 56015
Rēzekne, 4601, Latvia
Teva Investigational Site 56014
Riga, 1004, Latvia
Teva Investigational Site 56013
Riga, LV-1003, Latvia
Teva Investigational Site 56020
Riga, LV-1004, Latvia
Teva Investigational Site 56018
Riga, LV1010, Latvia
Teva Investigational Site 21125
Chihuahua City, 31203, Mexico
Teva Investigational Site 21122
Guadalajara, 44100, Mexico
Teva Investigational Site 21127
Guadalajara, 44670, Mexico
Teva Investigational Site 21126
Monterrey, 64460, Mexico
Teva Investigational Site 21123
Oaxaca City, 68000, Mexico
Teva Investigational Site 21129
Villahermosa, 86035, Mexico
Teva Investigational Site 79054
Auckland, 1010, New Zealand
Teva Investigational Site 79056
Auckland, 626, New Zealand
Teva Investigational Site 79055
Christchurch, 8013, New Zealand
Teva Investigational Site 79057
Dunedin, 9016, New Zealand
Teva Investigational Site 79051
Hamilton, 3204, New Zealand
Teva Investigational Site 79062
Nawton, 3200, New Zealand
Teva Investigational Site 79061
Nelson, 7011, New Zealand
Teva Investigational Site 79059
Rotorua, 3010, New Zealand
Teva Investigational Site 79060
South Hastings, 4122, New Zealand
Teva Investigational Site 79052
Tauranga, 3110, New Zealand
Teva Investigational Site 79058
Waikanae Beach, 5036, New Zealand
Teva Investigational Site 79050
Wellington, 6021, New Zealand
Teva Investigational Site 53531
Bialystok, 15-010, Poland
Teva Investigational Site 53527
Bialystok, 15-430, Poland
Teva Investigational Site 53534
Bydgoszcz, 85-796, Poland
Teva Investigational Site 53537
Elblag, 82-300, Poland
Teva Investigational Site 53524
Gdansk, 80-214, Poland
Teva Investigational Site 53538
Gdansk, 80-344, Poland
Teva Investigational Site 53530
Krakow, 31-141, Poland
Teva Investigational Site 53521
Krakow, 31-624, Poland
Teva Investigational Site 53528
Lodz, 93-513, Poland
Teva Investigational Site 53523
Lublin, 20-089, Poland
Teva Investigational Site 53533
Lublin, 20-095, Poland
Teva Investigational Site 53522
Maków Podhalański, 34-220, Poland
Teva Investigational Site 53525
Ostrowiec Świętokrzyski, 27-400, Poland
Teva Investigational Site 53532
Poznan, 60-693, Poland
Teva Investigational Site 53526
Rzeszów, 35-051, Poland
Teva Investigational Site 53536
Skierniewice, 96-100, Poland
Teva Investigational Site 53535
Warsaw, 00-632, Poland
Teva Investigational Site 53529
Zawadzkie, 47-120, Poland
Teva Investigational Site 52139
Bacau, 600625, Romania
Teva Investigational Site 52140
Bragadiru, 769764, Romania
Teva Investigational Site 52138
Bucharest, 12052, Romania
Teva Investigational Site 52136
Bucharest, 41507, Romania
Teva Investigational Site 52135
Cluj-Napoca, 400371, Romania
Teva Investigational Site 52137
Craiova, 200515, Romania
Teva Investigational Site 61071
Belgrade, 11000, Serbia
Teva Investigational Site 61073
Belgrade, 11000, Serbia
Teva Investigational Site 61074
Belgrade, 11000, Serbia
Teva Investigational Site 61075
Belgrade, 11000, Serbia
Teva Investigational Site 61080
Belgrade, 11000, Serbia
Teva Investigational Site 61076
Belgrade, 11070, Serbia
Teva Investigational Site 61077
Belgrade, 11080, Serbia
Teva Investigational Site 61072
Kamenitz, 21204, Serbia
Teva Investigational Site 61078
Kragujevac, 34000, Serbia
Teva Investigational Site 61070
Niš, 18000, Serbia
Teva Investigational Site 61079
Novi Sad, 21000, Serbia
Teva Investigational Site 62083
Bardejov, 08501, Slovakia
Teva Investigational Site 62082
Košice, 040 11, Slovakia
Teva Investigational Site 62080
Rimavská Sobota, 979 01, Slovakia
Teva Investigational Site 62077
Slovakia, 06224, Slovakia
Teva Investigational Site 62078
Spišská Nová Ves, 052 01, Slovakia
Teva Investigational Site 62079
Žilina, 01001, Slovakia
Teva Investigational Site 62081
Žilina, 1001, Slovakia
Teva Investigational Site 90078
Benoni, 1501, South Africa
Teva Investigational Site 90069
Cape Town, 7530, South Africa
Teva Investigational Site 90077
Cape Town, 7530, South Africa
Teva Investigational Site 90063
Cape Town, 7570, South Africa
Teva Investigational Site 90079
Cape Town, 7700, South Africa
Teva Investigational Site 90073
Chatsworth, 4092, South Africa
Teva Investigational Site 90067
Durban, 4092, South Africa
Teva Investigational Site 90070
Ennerdale, 1830, South Africa
Teva Investigational Site 90083
Germiston, 1401, South Africa
Teva Investigational Site 90062
Johannesburg, 2113, South Africa
Teva Investigational Site 90074
Krugersdorp, 1739, South Africa
Teva Investigational Site 90065
KwaDukuza, 4450, South Africa
Teva Investigational Site 90064
Middelburg, 1050, South Africa
Teva Investigational Site 90072
Midrand, 1685, South Africa
Teva Investigational Site 90071
Plettenberg Bay, 6600, South Africa
Teva Investigational Site 90081
Polokwane, 699, South Africa
Teva Investigational Site 90076
Pretoria, 0181, South Africa
Teva Investigational Site 90080
Raslouw, 0157, South Africa
Teva Investigational Site 90068
Roodepoort, 1724, South Africa
Teva Investigational Site 90066
Somerset West, 7130, South Africa
Teva Investigational Site 90082
Soweto, 1868, South Africa
Teva Investigational Site 87039
Seoul, 04763, South Korea
Teva Investigational Site 87044
Seoul, 1757, South Korea
Teva Investigational Site 87043
Seoul, 3312, South Korea
Teva Investigational Site 87042
Seoul, 3722, South Korea
Teva Investigational Site 87040
Seoul, 5505, South Korea
Teva Investigational Site 87041
Seoul, 6591, South Korea
Teva Investigational Site 31304
Badalona, 8916, Spain
Teva Investigational Site 31305
Barcelona, 08017, Spain
Teva Investigational Site 31307
Barcelona, 08035, Spain
Teva Investigational Site 31309
Córdoba, 14004, Spain
Teva Investigational Site 31303
Madrid, 28007, Spain
Teva Investigational Site 31310
Sabadell, 8208, Spain
Teva Investigational Site 31306
Santiago de Compostela, 15706, Spain
Teva Investigational Site 31311
Seville, 41013, Spain
Teva Investigational Site 31308
Valencia, 46015, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Teva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2023
First Posted
September 25, 2023
Study Start
August 30, 2023
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.