A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
- Registration Number
- NCT06052267
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
The primary objective of the study is to assess the efficacy of high dose and low 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 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 35 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2196
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TEV-56248 Low Dose TEV-56248 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. TEV-56248 High Dose TEV-56248 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. Albuterol sulfate Albuterol sulfate 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.
- Primary Outcome Measures
Name Time Method Time to First Severe Clinical Asthma Exacerbation (CAE) Up to 35 months
- Secondary Outcome Measures
Name Time Method Number of Participants with at Least One Serious Adverse Event Up to 35 months Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events Up to 35 months Annualized Severe CAE Rate Up to 35 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).
Asthma Control Questionnaire-5 (ACQ-5) Response 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.Total Annualized SCS Exposure Over the Treatment Period Up to 35 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.
Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ) 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.Number of Participants with at Least One Adverse Event Up to 35 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.
Trial Locations
- Locations (370)
Teva Investigational Site 59222
🇧🇬Plovdiv, Bulgaria
Teva Investigational Site 53524
🇵🇱Gdansk, Poland
Teva Investigational Site 53538
🇵🇱Gdansk, Poland
Teva Investigational Site 53530
🇵🇱Krakow, Poland
Teva Investigational Site 53521
🇵🇱Krakow, Poland
Teva Investigational Site 53528
🇵🇱Lodz, Poland
Teva Investigational Site 53523
🇵🇱Lublin, Poland
Teva Investigational Site 15768
🇺🇸Dothan, Alabama, United States
Teva Investigational Site 15581
🇺🇸Paradise Valley, Arizona, United States
Teva Investigational Site 15661
🇺🇸Tucson, Arizona, United States
Teva Investigational Site 15685
🇺🇸Bakersfield, California, United States
Teva Investigational Site 15721
🇺🇸Fresno, California, United States
Teva Investigational Site 15788
🇺🇸Huntington Beach, California, United States
Teva Investigational Site 15720
🇺🇸La Jolla, California, United States
Teva Investigational Site 15687
🇺🇸La Palma, California, United States
Teva Investigational Site 15708
🇺🇸Long Beach, California, United States
Teva Investigational Site 15712
🇺🇸Long Beach, California, United States
Teva Investigational Site 15643
🇺🇸Los Angeles, California, United States
Teva Investigational Site 15695
🇺🇸Napa, California, United States
Teva Investigational Site 15692
🇺🇸Northridge, California, United States
Teva Investigational Site 15682
🇺🇸Redondo Beach, California, United States
Teva Investigational Site 15629
🇺🇸San Bernardino, California, United States
Teva Investigational Site 15709
🇺🇸San Diego, California, United States
Teva Investigational Site 15704
🇺🇸San Jose, California, United States
Teva Investigational Site 15620
🇺🇸Stockton, California, United States
Teva Investigational Site 15621
🇺🇸Westminster, California, United States
Teva Investigational Site 15612
🇺🇸Aurora, Colorado, United States
Teva Investigational Site 15588
🇺🇸Colorado Springs, Colorado, United States
Teva Investigational Site 15765
🇺🇸Colorado Springs, Colorado, United States
Teva Investigational Site 15676
🇺🇸Englewood, Colorado, United States
Teva Investigational Site 15781
🇺🇸Washington, District of Columbia, United States
Teva Investigational Site 15660
🇺🇸Aventura, Florida, United States
Teva Investigational Site 15624
🇺🇸Cape Coral, Florida, United States
Teva Investigational Site 15598
🇺🇸Cutler Bay, Florida, United States
Teva Investigational Site 15776
🇺🇸Doral, Florida, United States
Teva Investigational Site 15579
🇺🇸Greenacres City, Florida, United States
Teva Investigational Site 15582
🇺🇸Hialeah, Florida, United States
Teva Investigational Site 15664
🇺🇸Hialeah, Florida, United States
Teva Investigational Site 15657
🇺🇸Homestead, Florida, United States
Teva Investigational Site 15713
🇺🇸Jacksonville, Florida, United States
Teva Investigational Site 15632
🇺🇸Leesburg, Florida, United States
Teva Investigational Site 15777
🇺🇸Margate, Florida, United States
Teva Investigational Site 15589
🇺🇸Miami Lakes, Florida, United States
Teva Investigational Site 15599
🇺🇸Miami Lakes, Florida, United States
Teva Investigational Site 15595
🇺🇸Miami Lakes, Florida, United States
Teva Investigational Site 15602
🇺🇸Miami, Florida, United States
Teva Investigational Site 15722
🇺🇸Miami, Florida, United States
Teva Investigational Site 15724
🇺🇸Miami, Florida, United States
Teva Investigational Site 15655
🇺🇸Miami, Florida, United States
Teva Investigational Site 15605
🇺🇸Miami, Florida, United States
Teva Investigational Site 15634
🇺🇸Miami, Florida, United States
Teva Investigational Site 15596
🇺🇸Miami, Florida, United States
Teva Investigational Site 15654
🇺🇸Miami, Florida, United States
Teva Investigational Site 15773
🇺🇸Miami, Florida, United States
Teva Investigational Site 15652
🇺🇸Miami, Florida, United States
Teva Investigational Site 15585
🇺🇸Miami, Florida, United States
Teva Investigational Site 15639
🇺🇸Miami, Florida, United States
Teva Investigational Site 15645
🇺🇸Miami, Florida, United States
Teva Investigational Site 15772
🇺🇸Miami, Florida, United States
Teva Investigational Site 15592
🇺🇸Miami, Florida, United States
Teva Investigational Site 15769
🇺🇸Miami, Florida, United States
Teva Investigational Site 15644
🇺🇸Miami, Florida, United States
Teva Investigational Site 15665
🇺🇸Oldsmar, Florida, United States
Teva Investigational Site 15659
🇺🇸Orlando, Florida, United States
Teva Investigational Site 15617
🇺🇸Orlando, Florida, United States
Teva Investigational Site 15625
🇺🇸Orlando, Florida, United States
Teva Investigational Site 15597
🇺🇸Pembroke Pines, Florida, United States
Teva Investigational Site 15767
🇺🇸Sweetwater, Florida, United States
Teva Investigational Site 15587
🇺🇸Tamarac, Florida, United States
Teva Investigational Site 15611
🇺🇸Tampa, Florida, United States
Teva Investigational Site 15619
🇺🇸Tampa, Florida, United States
Teva Investigational Site 15653
🇺🇸Tampa, Florida, United States
Teva Investigational Site 15606
🇺🇸Winter Park, Florida, United States
Teva Investigational Site 15711
🇺🇸College Park, Georgia, United States
Teva Investigational Site 15626
🇺🇸Savannah, Georgia, United States
Teva Investigational Site 15604
🇺🇸Boise, Idaho, United States
Teva Investigational Site 15669
🇺🇸Chicago, Illinois, United States
Teva Investigational Site 15600
🇺🇸Skokie, Illinois, United States
Teva Investigational Site 15674
🇺🇸Evansville, Indiana, United States
Teva Investigational Site 15580
🇺🇸Overland Park, Kansas, United States
Teva Investigational Site 15627
🇺🇸Lexington, Kentucky, United States
Teva Investigational Site 15770
🇺🇸Lafayette, Louisiana, United States
Teva Investigational Site 15667
🇺🇸Bangor, Maine, United States
Teva Investigational Site 15689
🇺🇸Rockville, Maryland, United States
Teva Investigational Site 15583
🇺🇸White Marsh, Maryland, United States
Teva Investigational Site 15628
🇺🇸Boston, Massachusetts, United States
Teva Investigational Site 15686
🇺🇸Fall River, Massachusetts, United States
Teva Investigational Site 15663
🇺🇸North Dartmouth, Massachusetts, United States
Teva Investigational Site 15764
🇺🇸South Dartmouth, Massachusetts, United States
Teva Investigational Site 15702
🇺🇸Detroit, Michigan, United States
Teva Investigational Site 15701
🇺🇸Flint, Michigan, United States
Teva Investigational Site 15593
🇺🇸Ypsilanti, Michigan, United States
Teva Investigational Site 15648
🇺🇸Kansas City, Missouri, United States
Teva Investigational Site 15640
🇺🇸Saint Louis, Missouri, United States
Teva Investigational Site 15650
🇺🇸Saint Louis, Missouri, United States
Teva Investigational Site 15633
🇺🇸Saint Louis, Missouri, United States
Teva Investigational Site 15679
🇺🇸Las Vegas, Nevada, United States
Teva Investigational Site 15725
🇺🇸North Bergen, New Jersey, United States
Teva Investigational Site 15688
🇺🇸Hawthorne, New York, United States
Teva Investigational Site 15603
🇺🇸Horseheads, New York, United States
Teva Investigational Site 15666
🇺🇸Hyde Park, New York, United States
Teva Investigational Site 15675
🇺🇸New Windsor, New York, United States
Teva Investigational Site 15618
🇺🇸Asheville, North Carolina, United States
Teva Investigational Site 15601
🇺🇸Chapel Hill, North Carolina, United States
Teva Investigational Site 15697
🇺🇸Charlotte, North Carolina, United States
Teva Investigational Site 15610
🇺🇸Elizabeth City, North Carolina, United States
Teva Investigational Site 15651
🇺🇸High Point, North Carolina, United States
Teva Investigational Site 15771
🇺🇸Statesville, North Carolina, United States
Teva Investigational Site 15631
🇺🇸Wilmington, North Carolina, United States
Teva Investigational Site 15584
🇺🇸Winston-Salem, North Carolina, United States
Teva Investigational Site 15607
🇺🇸Cincinnati, Ohio, United States
Teva Investigational Site 15613
🇺🇸Columbus, Ohio, United States
Teva Investigational Site 15784
🇺🇸Dayton, Ohio, United States
Teva Investigational Site 15780
🇺🇸Toledo, Ohio, United States
Teva Investigational Site 15662
🇺🇸Toledo, Ohio, United States
Teva Investigational Site 15577
🇺🇸Oklahoma City, Oklahoma, United States
Teva Investigational Site 15594
🇺🇸Tulsa, Oklahoma, United States
Teva Investigational Site 15775
🇺🇸Yukon, Oklahoma, United States
Teva Investigational Site 15646
🇺🇸Grants Pass, Oregon, United States
Teva Investigational Site 15642
🇺🇸Philadelphia, Pennsylvania, United States
Teva Investigational Site 15699
🇺🇸Philadelphia, Pennsylvania, United States
Teva Investigational Site 15576
🇺🇸Pittsburgh, Pennsylvania, United States
Teva Investigational Site 20138
🇦🇷Caba, Argentina
Teva Investigational Site 15608
🇺🇸North Charleston, South Carolina, United States
Teva Investigational Site 15672
🇺🇸Rock Hill, South Carolina, United States
Teva Investigational Site 15691
🇺🇸Knoxville, Tennessee, United States
Teva Investigational Site 15705
🇺🇸Austin, Texas, United States
Teva Investigational Site 15641
🇺🇸Boerne, Texas, United States
Teva Investigational Site 15778
🇺🇸Brownsville, Texas, United States
Teva Investigational Site 15668
🇺🇸Corsicana, Texas, United States
Teva Investigational Site 15658
🇺🇸Dallas, Texas, United States
Teva Investigational Site 15637
🇺🇸Dallas, Texas, United States
Teva Investigational Site 15623
🇺🇸Dallas, Texas, United States
Teva Investigational Site 15785
🇺🇸Edinburg, Texas, United States
Teva Investigational Site 15678
🇺🇸El Paso, Texas, United States
Teva Investigational Site 15787
🇺🇸El Paso, Texas, United States
Teva Investigational Site 15591
🇺🇸El Paso, Texas, United States
Teva Investigational Site 15696
🇺🇸Houston, Texas, United States
Teva Investigational Site 15680
🇺🇸Houston, Texas, United States
Teva Investigational Site 15614
🇺🇸Houston, Texas, United States
Teva Investigational Site 15578
🇺🇸Houston, Texas, United States
Teva Investigational Site 15690
🇺🇸Katy, Texas, United States
Teva Investigational Site 15684
🇺🇸Kerrville, Texas, United States
Teva Investigational Site 15630
🇺🇸McKinney, Texas, United States
Teva Investigational Site 15706
🇺🇸Plano, Texas, United States
Teva Investigational Site 15656
🇺🇸San Antonio, Texas, United States
Teva Investigational Site 15670
🇺🇸San Antonio, Texas, United States
Teva Investigational Site 15638
🇺🇸San Antonio, Texas, United States
Teva Investigational Site 15647
🇺🇸Sherman, Texas, United States
Teva Investigational Site 15673
🇺🇸Splendora, Texas, United States
Teva Investigational Site 15707
🇺🇸Tomball, Texas, United States
Teva Investigational Site 15693
🇺🇸Victoria, Texas, United States
Teva Investigational Site 15649
🇺🇸Waxahachie, Texas, United States
Teva Investigational Site 15671
🇺🇸Bountiful, Utah, United States
Teva Investigational Site 15635
🇺🇸Sandy, Utah, United States
Teva Investigational Site 15789
🇺🇸West Valley City, Utah, United States
Teva Investigational Site 15683
🇺🇸Williamsburg, Virginia, United States
Teva Investigational Site 15586
🇺🇸Greenfield, Wisconsin, United States
Teva Investigational Site 20109
🇦🇷Bahia Blanca, Argentina
Teva Investigational Site 20126
🇦🇷Bahia Blanca, Argentina
Teva Investigational Site 20130
🇦🇷Bahia Blanca, Argentina
Teva Investigational Site 20117
🇦🇷Buenos Aires Province, Argentina
Teva Investigational Site 20113
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 20111
🇦🇷Buenos Aires, Argentina
Teva Investigational Site 20129
🇦🇷CapitalFederal, Argentina
Teva Investigational Site 20135
🇦🇷Caba, Argentina
Teva Investigational Site 20128
🇦🇷Caba, Argentina
Teva Investigational Site 20139
🇦🇷Caba, Argentina
Teva Investigational Site 20121
🇦🇷Ciudad de Mendoza, Argentina
Teva Investigational Site 20118
🇦🇷Concepcion del Uruguay, Argentina
Teva Investigational Site 20106
🇦🇷Cordoba Capital, Argentina
Teva Investigational Site 20114
🇦🇷Florencio Varela, Argentina
Teva Investigational Site 20125
🇦🇷Florida, Vicente Lopez, Argentina
Teva Investigational Site 20136
🇦🇷Godoy Cruz, Argentina
Teva Investigational Site 20122
🇦🇷Lanus Este, Argentina
Teva Investigational Site 20107
🇦🇷Lobos, Argentina
Teva Investigational Site 20123
🇦🇷Mar Del Plata, Argentina
Teva Investigational Site 20127
🇦🇷Mendoza, Argentina
Teva Investigational Site 20110
🇦🇷Mendoza, Argentina
Teva Investigational Site 20115
🇦🇷Mendoza, Argentina
Teva Investigational Site 20140
🇦🇷Parana, Argentina
Teva Investigational Site 20112
🇦🇷Quilmes, Argentina
Teva Investigational Site 20119
🇦🇷Rosario, Argentina
Teva Investigational Site 20120
🇦🇷Rosario, Argentina
Teva Investigational Site 20105
🇦🇷Rosario, Argentina
Teva Investigational Site 20133
🇦🇷San Fernando, Argentina
Teva Investigational Site 20104
🇦🇷San Miguel de Tucuman, Argentina
Teva Investigational Site 20124
🇦🇷San Miguel De Tucuman, Argentina
Teva Investigational Site 20131
🇦🇷San Miguel de Tucuman, Argentina
Teva Investigational Site 20137
🇦🇷San Miguel de Tucuman, Argentina
Teva Investigational Site 78127
🇦🇺South Brisbane, Australia
Teva Investigational Site 20116
🇦🇷San Rafael, Argentina
Teva Investigational Site 20132
🇦🇷Santa Fe, Argentina
Teva Investigational Site 78131
🇦🇺Box Hill, Australia
Teva Investigational Site 78133
🇦🇺Melbourne, Australia
Teva Investigational Site 78132
🇦🇺Midland, Australia
Teva Investigational Site 78130
🇦🇺Nedlands, Australia
Teva Investigational Site 78134
🇦🇺North Adelaide, Australia
Teva Investigational Site 78128
🇦🇺Parkville, Australia
Teva Investigational Site 59230
🇧🇬Blagoevgrad, Bulgaria
Teva Investigational Site 59227
🇧🇬Kozloduy, Bulgaria
Teva Investigational Site 59218
🇧🇬Pernik, Bulgaria
Teva Investigational Site 59237
🇧🇬Pleven, Bulgaria
Teva Investigational Site 59219
🇧🇬Ruse, Bulgaria
Teva Investigational Site 59231
🇧🇬Sliven, Bulgaria
Teva Investigational Site 59224
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59226
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59235
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59228
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59234
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59221
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59220
🇧🇬Stara Zagora, Bulgaria
Teva Investigational Site 59232
🇧🇬Varna, Bulgaria
Teva Investigational Site 59229
🇧🇬Vratsa, Bulgaria
Teva Investigational Site 11267
🇨🇦Edmonton, Alberta, Canada
Teva Investigational Site 11272
🇨🇦Ajax, Ontario, Canada
Teva Investigational Site 11270
🇨🇦Etobicoke, Ontario, Canada
Teva Investigational Site 11274
🇨🇦Hamilton, Ontario, Canada
Teva Investigational Site 11271
🇨🇦Winchester, Ontario, Canada
Teva Investigational Site 11273
🇨🇦Windsor, Ontario, Canada
Teva Investigational Site 54231
🇨🇿Brandys Nad Labem-stara Boleslav, Czechia
Teva Investigational Site 54232
🇨🇿Brno, Czechia
Teva Investigational Site 54229
🇨🇿Jihlava, Czechia
Teva Investigational Site 54226
🇨🇿Jindrichuv Hradec, Czechia
Teva Investigational Site 54225
🇨🇿Lovosice, Czechia
Teva Investigational Site 54228
🇨🇿Ostrava, Czechia
Teva Investigational Site 32848
🇩🇪Hamburg, Germany
Teva Investigational Site 54230
🇨🇿Prague, Czechia
Teva Investigational Site 54227
🇨🇿Varnsdorf, Czechia
Teva Investigational Site 39099
🇩🇰Aalborg, Denmark
Teva Investigational Site 39100
🇩🇰Hvidovre, Denmark
Teva Investigational Site 39098
🇩🇰Vejle, Denmark
Teva Investigational Site 32846
🇩🇪Augsburg, Germany
Teva Investigational Site 32835
🇩🇪Berlin, Germany
Teva Investigational Site 32834
🇩🇪Berlin, Germany
Teva Investigational Site 32833
🇩🇪Berlin, Germany
Teva Investigational Site 32840
🇩🇪Cottbus, Germany
Teva Investigational Site 32829
🇩🇪Darmstadt, Germany
Teva Investigational Site 32850
🇩🇪Delitzsch, Germany
Teva Investigational Site 32853
🇩🇪Essen, Germany
Teva Investigational Site 32845
🇩🇪Frankfurt Am Main, Germany
Teva Investigational Site 32831
🇩🇪Frankfurt, Germany
Teva Investigational Site 32838
🇩🇪Hamburg, Germany
Teva Investigational Site 32827
🇩🇪Hamburg, Germany
Teva Investigational Site 32841
🇩🇪Hannover, Germany
Teva Investigational Site 32842
🇩🇪Heidelberg, Germany
Teva Investigational Site 32851
🇩🇪Ibbenbueren, Germany
Teva Investigational Site 32830
🇩🇪Leipzig - Nordost, Germany
Teva Investigational Site 32844
🇩🇪Leipzig, Germany
Teva Investigational Site 32832
🇩🇪Mainz A. Rhein, Germany
Teva Investigational Site 32847
🇩🇪Munchen, Germany
Teva Investigational Site 32828
🇩🇪Munchen, Germany
Teva Investigational Site 32843
🇩🇪Neu-Isenburg, Germany
Teva Investigational Site 32839
🇩🇪Neuss, Germany
Teva Investigational Site 32836
🇩🇪Peine, Germany
Teva Investigational Site 32849
🇩🇪Wiesbaden, Germany
Teva Investigational Site 32852
🇩🇪Witten, Germany
Teva Investigational Site 63086
🇬🇷Athens, Greece
Teva Investigational Site 63085
🇬🇷Evros, Greece
Teva Investigational Site 63087
🇬🇷Larissa, Greece
Teva Investigational Site 63082
🇬🇷Thessaloniki, Greece
Teva Investigational Site 63083
🇬🇷Thessaloniki, Greece
Teva Investigational Site 51346
🇭🇺Budapest, Hungary
Teva Investigational Site 51344
🇭🇺Budapest, Hungary
Teva Investigational Site 51340
🇭🇺Budapest, Hungary
Teva Investigational Site 51342
🇭🇺Debrecen, Hungary
Teva Investigational Site 51345
🇭🇺Mosonmagyarovar, Hungary
Teva Investigational Site 51343
🇭🇺Pecs, Hungary
Teva Investigational Site 51339
🇭🇺Szeged, Hungary
Teva Investigational Site 51341
🇭🇺Szigetvar, Hungary
Teva Investigational Site 80196
🇮🇱Ashkelon, Israel
Teva Investigational Site 80201
🇮🇱Beer Sheva, Israel
Teva Investigational Site 80200
🇮🇱Haifa, Israel
Teva Investigational Site 80194
🇮🇱Jerusalem, Israel
Teva Investigational Site 80198
🇮🇱Jerusalem, Israel
Teva Investigational Site 80199
🇮🇱Petach Tikvah, Israel
Teva Investigational Site 80195
🇮🇱Petah Tikva, Israel
Teva Investigational Site 80193
🇮🇱Rehovot, Israel
Teva Investigational Site 80197
🇮🇱Tel Aviv-Yafo, Israel
Teva Investigational Site 30306
🇮🇹Ferrara, Italy
Teva Investigational Site 30317
🇮🇹Pisa, Italy
Teva Investigational Site 30307
🇮🇹Verona, Italy
Teva Investigational Site 87039
🇰🇷Seoul, Korea, Republic of
Teva Investigational Site 87044
🇰🇷Seoul, Korea, Republic of
Teva Investigational Site 87043
🇰🇷Seoul, Korea, Republic of
Teva Investigational Site 87042
🇰🇷Seoul, Korea, Republic of
Teva Investigational Site 87040
🇰🇷Seoul, Korea, Republic of
Teva Investigational Site 87041
🇰🇷Seoul, Korea, Republic of
Teva Investigational Site 56016
🇱🇻Balvi, Latvia
Teva Investigational Site 56019
🇱🇻Daugavpils, Latvia
Teva Investigational Site 56017
🇱🇻Jurmala, Latvia
Teva Investigational Site 56015
🇱🇻Rezekne, Latvia
Teva Investigational Site 56014
🇱🇻Riga, Latvia
Teva Investigational Site 56013
🇱🇻Riga, Latvia
Teva Investigational Site 56020
🇱🇻Riga, Latvia
Teva Investigational Site 53537
🇵🇱Elblag, Poland
Teva Investigational Site 56018
🇱🇻Riga, Latvia
Teva Investigational Site 79054
🇳🇿Auckland, New Zealand
Teva Investigational Site 79056
🇳🇿Auckland, New Zealand
Teva Investigational Site 79055
🇳🇿Christchurch, New Zealand
Teva Investigational Site 79057
🇳🇿Dunedin, New Zealand
Teva Investigational Site 79051
🇳🇿Hamilton, New Zealand
Teva Investigational Site 79062
🇳🇿Nawton, New Zealand
Teva Investigational Site 79061
🇳🇿Nelson, New Zealand
Teva Investigational Site 79059
🇳🇿Rotorua, New Zealand
Teva Investigational Site 79060
🇳🇿South Hastings, New Zealand
Teva Investigational Site 79052
🇳🇿Tauranga, New Zealand
Teva Investigational Site 79058
🇳🇿Waikanae Beach, New Zealand
Teva Investigational Site 79050
🇳🇿Wellington, New Zealand
Teva Investigational Site 53531
🇵🇱Bialystok, Poland
Teva Investigational Site 53527
🇵🇱Bialystok, Poland
Teva Investigational Site 53534
🇵🇱Bydgoszcz, Poland
Teva Investigational Site 53522
🇵🇱Makow Podhalanski, Poland
Teva Investigational Site 53525
🇵🇱Ostrowiec Swietokrzyski, Poland
Teva Investigational Site 53532
🇵🇱Poznan, Poland
Teva Investigational Site 53526
🇵🇱Rzeszow, Poland
Teva Investigational Site 53536
🇵🇱Skierniewice, Poland
Teva Investigational Site 53535
🇵🇱Warszawa, Poland
Teva Investigational Site 53529
🇵🇱Zawadzkie, Poland
Teva Investigational Site 52139
🇷🇴Bacau, Romania
Teva Investigational Site 52140
🇷🇴Bragadiru, Romania
Teva Investigational Site 52138
🇷🇴Bucuresti, Romania
Teva Investigational Site 52136
🇷🇴Bucuresti, Romania
Teva Investigational Site 52135
🇷🇴Cluj Napoca, Romania
Teva Investigational Site 52137
🇷🇴Craiova, Romania
Teva Investigational Site 61071
🇷🇸Belgrade, Serbia
Teva Investigational Site 61075
🇷🇸Belgrade, Serbia
Teva Investigational Site 61076
🇷🇸Belgrade, Serbia
Teva Investigational Site 61073
🇷🇸Beograd, Serbia
Teva Investigational Site 61074
🇷🇸Beograd, Serbia
Teva Investigational Site 61080
🇷🇸Beograd, Serbia
Teva Investigational Site 61077
🇷🇸Beograd, Serbia
Teva Investigational Site 61078
🇷🇸Kragujevac, Serbia
Teva Investigational Site 61070
🇷🇸Nis, Serbia
Teva Investigational Site 61079
🇷🇸Novi Sad, Serbia
Teva Investigational Site 61072
🇷🇸Sremska Kamenica, Serbia
Teva Investigational Site 62083
🇸🇰Bardejov, Slovakia
Teva Investigational Site 62082
🇸🇰Kosice, Slovakia
Teva Investigational Site 62080
🇸🇰Rimavska Sobota, Slovakia
Teva Investigational Site 62077
🇸🇰Slovakia, Slovakia
Teva Investigational Site 62078
🇸🇰Spisska Nova Ves, Slovakia
Teva Investigational Site 62079
🇸🇰Zilina, Slovakia
Teva Investigational Site 62081
🇸🇰Zilina, Slovakia
Teva Investigational Site 90078
🇿🇦Benoni, South Africa
Teva Investigational Site 90069
🇿🇦Cape Town, South Africa
Teva Investigational Site 90077
🇿🇦Cape Town, South Africa
Teva Investigational Site 90063
🇿🇦Cape town, South Africa
Teva Investigational Site 90079
🇿🇦Cape Town, South Africa
Teva Investigational Site 90073
🇿🇦Chatsworth, South Africa
Teva Investigational Site 90067
🇿🇦Durban, South Africa
Teva Investigational Site 90070
🇿🇦Ennerdale, South Africa
Teva Investigational Site 90083
🇿🇦Germiston, South Africa
Teva Investigational Site 90062
🇿🇦Johannesburg, South Africa
Teva Investigational Site 90074
🇿🇦Krugersdorp, South Africa
Teva Investigational Site 90064
🇿🇦Middelburg, South Africa
Teva Investigational Site 90072
🇿🇦Midrand, South Africa
Teva Investigational Site 90071
🇿🇦Plettenberg Bay, South Africa
Teva Investigational Site 90081
🇿🇦Polokwane, South Africa
Teva Investigational Site 90076
🇿🇦Pretoria, South Africa
Teva Investigational Site 90080
🇿🇦Raslouw, South Africa
Teva Investigational Site 90068
🇿🇦Roodepoort, South Africa
Teva Investigational Site 90066
🇿🇦Somerset West, South Africa
Teva Investigational Site 90065
🇿🇦Stanger, South Africa
Teva Investigational Site 31305
🇪🇸Barcelona, Spain
Teva Investigational Site 31307
🇪🇸Barcelona, Spain
Teva Investigational Site 31309
🇪🇸Cordoba, Spain
Teva Investigational Site 31303
🇪🇸Madrid, Spain
Teva Investigational Site 31306
🇪🇸Santiago de Compostela, Spain
Teva Investigational Site 31311
🇪🇸Sevilla, Spain
Teva Investigational Site 31308
🇪🇸Valencia, Spain