Clinical trial NCT06052267: A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 2196
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to First Severe Clinical Asthma Exacerbation (CAE)
timeFrame: Up to 35 months
Secondary outcomes:
measure: Annualized Severe CAE Rate
timeFrame: Up to 35 months
measure: Total Annualized SCS Exposure Over the Treatment Period
timeFrame: Up to 35 months
measure: Asthma Control Questionnaire-5 (ACQ-5) Response
timeFrame: Baseline, Week 24
measure: Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)
timeFrame: Baseline, Week 24
measure: Number of Participants with at Least One Adverse Event
timeFrame: Up to 35 months
measure: Number of Participants with at Least One Serious Adverse Event
timeFrame: Up to 35 months
measure: Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events
timeFrame: Up to 35 months
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Teva Investigational Site 15768
state: Alabama
city: Paradise Valley
country: United States
facility: Teva Investigational Site 15581
state: Arizona
city: Tucson
country: United States
facility: Teva Investigational Site 15661
state: Arizona
city: Bakersfield
country: United States
facility: Teva Investigational Site 15685
state: California
city: Fresno
country: United States
facility: Teva Investigational Site 15721
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 15788
state: California
city: La Jolla
country: United States
facility: Teva Investigational Site 15720
state: California
city: La Palma
country: United States
facility: Teva Investigational Site 15687
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 15708
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 15712
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 15643
state: California
city: Napa
country: United States
facility: Teva Investigational Site 15695
state: California
city: Northridge
country: United States
facility: Teva Investigational Site 15692
state: California
city: Redondo Beach
country: United States
facility: Teva Investigational Site 15682
state: California
city: San Bernardino
country: United States
facility: Teva Investigational Site 15629
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 15709
state: California
city: San Jose
country: United States
facility: Teva Investigational Site 15704
state: California
city: Stockton
country: United States
facility: Teva Investigational Site 15620
state: California
city: Westminster
country: United States
facility: Teva Investigational Site 15621
state: California
city: Aurora
country: United States
facility: Teva Investigational Site 15612
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 15588
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 15765
state: Colorado
city: Englewood
country: United States
facility: Teva Investigational Site 15676
state: Colorado
city: Washington
country: United States
facility: Teva Investigational Site 15781
state: District of Columbia
city: Aventura
country: United States
facility: Teva Investigational Site 15660
state: Florida
city: Cape Coral
country: United States
facility: Teva Investigational Site 15624
state: Florida
city: Cutler Bay
country: United States
facility: Teva Investigational Site 15598
state: Florida
city: Doral
country: United States
facility: Teva Investigational Site 15776
state: Florida
city: Greenacres City
country: United States
facility: Teva Investigational Site 15579
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 15582
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 15664
state: Florida
city: Homestead
country: United States
facility: Teva Investigational Site 15657
state: Florida
city: Jacksonville
country: United States
facility: Teva Investigational Site 15713
state: Florida
city: Leesburg
country: United States
facility: Teva Investigational Site 15632
state: Florida
city: Margate
country: United States
facility: Teva Investigational Site 15777
state: Florida
city: Miami Lakes
country: United States
facility: Teva Investigational Site 15589
state: Florida
city: Miami Lakes
country: United States
facility: Teva Investigational Site 15599
state: Florida
city: Miami Lakes
country: United States
facility: Teva Investigational Site 15595
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15602
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15722
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15724
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15655
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15605
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15634
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15596
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15654
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15773
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15652
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15585
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15639
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15645
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15772
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15592
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15769
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 15644
state: Florida
city: Oldsmar
country: United States
facility: Teva Investigational Site 15665
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 15659
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 15617
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 15625
state: Florida
city: Pembroke Pines
country: United States
facility: Teva Investigational Site 15597
state: Florida
city: Sweetwater
country: United States
facility: Teva Investigational Site 15767
state: Florida
city: Tamarac
country: United States
facility: Teva Investigational Site 15587
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 15611
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 15619
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 15653
state: Florida
city: Winter Park
country: United States
facility: Teva Investigational Site 15606
state: Florida
city: College Park
country: United States
facility: Teva Investigational Site 15711
state: Georgia
city: Savannah
country: United States
facility: Teva Investigational Site 15626
state: Georgia
city: Boise
country: United States
facility: Teva Investigational Site 15604
state: Idaho
city: Chicago
country: United States
facility: Teva Investigational Site 15669
state: Illinois
city: Skokie
country: United States
facility: Teva Investigational Site 15600
state: Illinois
city: Evansville
country: United States
facility: Teva Investigational Site 15674
state: Indiana
city: Overland Park
country: United States
facility: Teva Investigational Site 15580
state: Kansas
city: Lexington
country: United States
facility: Teva Investigational Site 15627
state: Kentucky
city: Lafayette
country: United States
facility: Teva Investigational Site 15770
state: Louisiana
city: Bangor
country: United States
facility: Teva Investigational Site 15667
state: Maine
city: Rockville
country: United States
facility: Teva Investigational Site 15689
state: Maryland
city: White Marsh
country: United States
facility: Teva Investigational Site 15583
state: Maryland
city: Boston
country: United States
facility: Teva Investigational Site 15628
state: Massachusetts
city: Fall River
country: United States
facility: Teva Investigational Site 15686
state: Massachusetts
city: North Dartmouth
country: United States
facility: Teva Investigational Site 15663
state: Massachusetts
city: South Dartmouth
country: United States
facility: Teva Investigational Site 15764
state: Massachusetts
city: Detroit
country: United States
facility: Teva Investigational Site 15702
state: Michigan
city: Flint
country: United States
facility: Teva Investigational Site 15701
state: Michigan
city: Ypsilanti
country: United States
facility: Teva Investigational Site 15593
state: Michigan
city: Kansas City
country: United States
facility: Teva Investigational Site 15648
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 15640
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 15650
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 15633
state: Missouri
city: Las Vegas
country: United States
facility: Teva Investigational Site 15679
state: Nevada
city: North Bergen
country: United States
facility: Teva Investigational Site 15725
state: New Jersey
city: Hawthorne
country: United States
facility: Teva Investigational Site 15688
state: New York
city: Horseheads
country: United States
facility: Teva Investigational Site 15603
state: New York
city: Hyde Park
country: United States
facility: Teva Investigational Site 15666
state: New York
city: New Windsor
country: United States
facility: Teva Investigational Site 15675
state: New York
city: Asheville
country: United States
facility: Teva Investigational Site 15618
state: North Carolina
city: Chapel Hill
country: United States
facility: Teva Investigational Site 15601
state: North Carolina
city: Charlotte
country: United States
facility: Teva Investigational Site 15697
state: North Carolina
city: Elizabeth City
country: United States
facility: Teva Investigational Site 15610
state: North Carolina
city: High Point
country: United States
facility: Teva Investigational Site 15651
state: North Carolina
city: Statesville
country: United States
facility: Teva Investigational Site 15771
state: North Carolina
city: Wilmington
country: United States
facility: Teva Investigational Site 15631
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 15584
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 15607
state: Ohio
city: Columbus
country: United States
facility: Teva Investigational Site 15613
state: Ohio
city: Dayton
country: United States
facility: Teva Investigational Site 15784
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 15780
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 15662
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 15577
state: Oklahoma
city: Tulsa
country: United States
facility: Teva Investigational Site 15594
state: Oklahoma
city: Yukon
country: United States
facility: Teva Investigational Site 15775
state: Oklahoma
city: Grants Pass
country: United States
facility: Teva Investigational Site 15646
state: Oregon
city: Philadelphia
country: United States
facility: Teva Investigational Site 15642
state: Pennsylvania
city: Philadelphia
country: United States
facility: Teva Investigational Site 15699
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 15576
state: Pennsylvania
city: North Charleston
country: United States
facility: Teva Investigational Site 15608
state: South Carolina
city: Rock Hill
country: United States
facility: Teva Investigational Site 15672
state: South Carolina
city: Knoxville
country: United States
facility: Teva Investigational Site 15691
state: Tennessee
city: Austin
country: United States
facility: Teva Investigational Site 15705
state: Texas
city: Boerne
country: United States
facility: Teva Investigational Site 15641
state: Texas
city: Brownsville
country: United States
facility: Teva Investigational Site 15778
state: Texas
city: Corsicana
country: United States
facility: Teva Investigational Site 15668
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 15658
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 15637
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 15623
state: Texas
city: Edinburg
country: United States
facility: Teva Investigational Site 15785
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 15678
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 15787
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 15591
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 15696
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 15680
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 15614
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 15578
state: Texas
city: Katy
country: United States
facility: Teva Investigational Site 15690
state: Texas
city: Kerrville
country: United States
facility: Teva Investigational Site 15684
state: Texas
city: McKinney
country: United States
facility: Teva Investigational Site 15630
state: Texas
city: Plano
country: United States
facility: Teva Investigational Site 15706
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 15656
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 15670
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 15638
state: Texas
city: Sherman
country: United States
facility: Teva Investigational Site 15647
state: Texas
city: Splendora
country: United States
facility: Teva Investigational Site 15673
state: Texas
city: Tomball
country: United States
facility: Teva Investigational Site 15707
state: Texas
city: Victoria
country: United States
facility: Teva Investigational Site 15693
state: Texas
city: Waxahachie
country: United States
facility: Teva Investigational Site 15649
state: Texas
city: Bountiful
country: United States
facility: Teva Investigational Site 15671
state: Utah
city: Sandy
country: United States
facility: Teva Investigational Site 15635
state: Utah
city: West Valley City
country: United States
facility: Teva Investigational Site 15789
state: Utah
city: Williamsburg
country: United States
facility: Teva Investigational Site 15683
state: Virginia
city: Greenfield
country: United States
facility: Teva Investigational Site 15586
state: Wisconsin
city: Bahia Blanca
country: Argentina
facility: Teva Investigational Site 20109
city: Bahia Blanca
country: Argentina
facility: Teva Investigational Site 20126
city: Bahia Blanca
country: Argentina
facility: Teva Investigational Site 20130
city: Buenos Aires Province
country: Argentina
facility: Teva Investigational Site 20117
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20113
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20111
city: Caba
country: Argentina
facility: Teva Investigational Site 20135
city: Caba
country: Argentina
facility: Teva Investigational Site 20128
city: Caba
country: Argentina
facility: Teva Investigational Site 20139
city: Caba
country: Argentina
facility: Teva Investigational Site 20138
city: CapitalFederal
country: Argentina
facility: Teva Investigational Site 20129
city: Ciudad de Mendoza
country: Argentina
facility: Teva Investigational Site 20121
city: Concepcion del Uruguay
country: Argentina
facility: Teva Investigational Site 20118
city: Cordoba Capital
country: Argentina
facility: Teva Investigational Site 20106
city: Florencio Varela
country: Argentina
facility: Teva Investigational Site 20114
city: Florida, Vicente Lopez
country: Argentina
facility: Teva Investigational Site 20125
city: Godoy Cruz
country: Argentina
facility: Teva Investigational Site 20136
city: Lanus Este
country: Argentina
facility: Teva Investigational Site 20122
city: Lobos
country: Argentina
facility: Teva Investigational Site 20107
city: Mar Del Plata
country: Argentina
facility: Teva Investigational Site 20123
city: Mendoza
country: Argentina
facility: Teva Investigational Site 20127
city: Mendoza
country: Argentina
facility: Teva Investigational Site 20110
city: Mendoza
country: Argentina
facility: Teva Investigational Site 20115
city: Parana
country: Argentina
facility: Teva Investigational Site 20140
city: Quilmes
country: Argentina
facility: Teva Investigational Site 20112
city: Rosario
country: Argentina
facility: Teva Investigational Site 20119
city: Rosario
country: Argentina
facility: Teva Investigational Site 20120
city: Rosario
country: Argentina
facility: Teva Investigational Site 20105
city: San Fernando
country: Argentina
facility: Teva Investigational Site 20133
city: San Miguel de Tucuman
country: Argentina
facility: Teva Investigational Site 20104
city: San Miguel De Tucuman
country: Argentina
facility: Teva Investigational Site 20124
city: San Miguel de Tucuman
country: Argentina
facility: Teva Investigational Site 20131
city: San Miguel de Tucuman
country: Argentina
facility: Teva Investigational Site 20137
city: San Rafael
country: Argentina
facility: Teva Investigational Site 20116
city: Santa Fe
country: Argentina
facility: Teva Investigational Site 20132
city: Box Hill
country: Australia
facility: Teva Investigational Site 78131
city: Melbourne
country: Australia
facility: Teva Investigational Site 78133
city: Midland
country: Australia
facility: Teva Investigational Site 78132
city: Nedlands
country: Australia
facility: Teva Investigational Site 78130
city: North Adelaide
country: Australia
facility: Teva Investigational Site 78134
city: Parkville
country: Australia
facility: Teva Investigational Site 78128
city: South Brisbane
country: Australia
facility: Teva Investigational Site 78127
city: Blagoevgrad
country: Bulgaria
facility: Teva Investigational Site 59230
city: Kozloduy
country: Bulgaria
facility: Teva Investigational Site 59227
city: Pernik
country: Bulgaria
facility: Teva Investigational Site 59218
city: Pleven
country: Bulgaria
facility: Teva Investigational Site 59237
city: Plovdiv
country: Bulgaria
facility: Teva Investigational Site 59222
city: Ruse
country: Bulgaria
facility: Teva Investigational Site 59219
city: Sliven
country: Bulgaria
facility: Teva Investigational Site 59231
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59224
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59226
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59235
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59228
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59234
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59221
city: Stara Zagora
country: Bulgaria
facility: Teva Investigational Site 59220
city: Varna
country: Bulgaria
facility: Teva Investigational Site 59232
city: Vratsa
country: Bulgaria
facility: Teva Investigational Site 59229
city: Edmonton
country: Canada
facility: Teva Investigational Site 11267
state: Alberta
city: Ajax
country: Canada
facility: Teva Investigational Site 11272
state: Ontario
city: Etobicoke
country: Canada
facility: Teva Investigational Site 11270
state: Ontario
city: Hamilton
country: Canada
facility: Teva Investigational Site 11274
state: Ontario
city: Winchester
country: Canada
facility: Teva Investigational Site 11271
state: Ontario
city: Windsor
country: Canada
facility: Teva Investigational Site 11273
state: Ontario
city: Brandys Nad Labem-stara Boleslav
country: Czechia
facility: Teva Investigational Site 54231
city: Brno
country: Czechia
facility: Teva Investigational Site 54232
city: Jihlava
country: Czechia
facility: Teva Investigational Site 54229
city: Jindrichuv Hradec
country: Czechia
facility: Teva Investigational Site 54226
city: Lovosice
country: Czechia
facility: Teva Investigational Site 54225
city: Ostrava
country: Czechia
facility: Teva Investigational Site 54228
city: Prague
country: Czechia
facility: Teva Investigational Site 54230
city: Varnsdorf
country: Czechia
facility: Teva Investigational Site 54227
city: Aalborg
country: Denmark
facility: Teva Investigational Site 39099
city: Hvidovre
country: Denmark
facility: Teva Investigational Site 39100
city: Vejle
country: Denmark
facility: Teva Investigational Site 39098
city: Augsburg
country: Germany
facility: Teva Investigational Site 32846
city: Berlin
country: Germany
facility: Teva Investigational Site 32835
city: Berlin
country: Germany
facility: Teva Investigational Site 32834
city: Berlin
country: Germany
facility: Teva Investigational Site 32833
city: Cottbus
country: Germany
facility: Teva Investigational Site 32840
city: Darmstadt
country: Germany
facility: Teva Investigational Site 32829
city: Delitzsch
country: Germany
facility: Teva Investigational Site 32850
city: Essen
country: Germany
facility: Teva Investigational Site 32853
city: Frankfurt Am Main
country: Germany
facility: Teva Investigational Site 32845
city: Frankfurt
country: Germany
facility: Teva Investigational Site 32831
city: Hamburg
country: Germany
facility: Teva Investigational Site 32838
city: Hamburg
country: Germany
facility: Teva Investigational Site 32827
city: Hamburg
country: Germany
facility: Teva Investigational Site 32848
city: Hannover
country: Germany
facility: Teva Investigational Site 32841
city: Heidelberg
country: Germany
facility: Teva Investigational Site 32842
city: Ibbenbueren
country: Germany
facility: Teva Investigational Site 32851
city: Leipzig - Nordost
country: Germany
facility: Teva Investigational Site 32830
city: Leipzig
country: Germany
facility: Teva Investigational Site 32844
city: Mainz A. Rhein
country: Germany
facility: Teva Investigational Site 32832
city: Munchen
country: Germany
facility: Teva Investigational Site 32847
city: Munchen
country: Germany
facility: Teva Investigational Site 32828
city: Neu-Isenburg
country: Germany
facility: Teva Investigational Site 32843
city: Neuss
country: Germany
facility: Teva Investigational Site 32839
city: Peine
country: Germany
facility: Teva Investigational Site 32836
city: Wiesbaden
country: Germany
facility: Teva Investigational Site 32849
city: Witten
country: Germany
facility: Teva Investigational Site 32852
city: Athens
country: Greece
facility: Teva Investigational Site 63086
city: Evros
country: Greece
facility: Teva Investigational Site 63085
city: Larissa
country: Greece
facility: Teva Investigational Site 63087
city: Thessaloniki
country: Greece
facility: Teva Investigational Site 63082
city: Thessaloniki
country: Greece
facility: Teva Investigational Site 63083
city: Budapest
country: Hungary
facility: Teva Investigational Site 51346
city: Budapest
country: Hungary
facility: Teva Investigational Site 51344
city: Budapest
country: Hungary
facility: Teva Investigational Site 51340
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51342
city: Mosonmagyarovar
country: Hungary
facility: Teva Investigational Site 51345
city: Pecs
country: Hungary
facility: Teva Investigational Site 51343
city: Szeged
country: Hungary
facility: Teva Investigational Site 51339
city: Szigetvar
country: Hungary
facility: Teva Investigational Site 51341
city: Ashkelon
country: Israel
facility: Teva Investigational Site 80196
city: Beer Sheva
country: Israel
facility: Teva Investigational Site 80201
city: Haifa
country: Israel
facility: Teva Investigational Site 80200
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80194
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80198
city: Petach Tikvah
country: Israel
facility: Teva Investigational Site 80199
city: Petah Tikva
country: Israel
facility: Teva Investigational Site 80195
city: Rehovot
country: Israel
facility: Teva Investigational Site 80193
city: Tel Aviv-Yafo
country: Israel
facility: Teva Investigational Site 80197
city: Ferrara
country: Italy
facility: Teva Investigational Site 30306
city: Pisa
country: Italy
facility: Teva Investigational Site 30317
city: Verona
country: Italy
facility: Teva Investigational Site 30318
city: Verona
country: Italy
facility: Teva Investigational Site 30307
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87039
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87044
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87043
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87042
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87040
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87041
city: Balvi
country: Latvia
facility: Teva Investigational Site 56016
city: Daugavpils
country: Latvia
facility: Teva Investigational Site 56019
city: Jurmala
country: Latvia
facility: Teva Investigational Site 56017
city: Rezekne
country: Latvia
facility: Teva Investigational Site 56015
city: Riga
country: Latvia
facility: Teva Investigational Site 56014
city: Riga
country: Latvia
facility: Teva Investigational Site 56013
city: Riga
country: Latvia
facility: Teva Investigational Site 56020
city: Riga
country: Latvia
facility: Teva Investigational Site 56018
city: Auckland
country: New Zealand
facility: Teva Investigational Site 79054
city: Auckland
country: New Zealand
facility: Teva Investigational Site 79056
city: Christchurch
country: New Zealand
facility: Teva Investigational Site 79055
city: Dunedin
country: New Zealand
facility: Teva Investigational Site 79057
city: Hamilton
country: New Zealand
facility: Teva Investigational Site 79051
city: Nawton
country: New Zealand
facility: Teva Investigational Site 79062
city: Nelson
country: New Zealand
facility: Teva Investigational Site 79061
city: Rotorua
country: New Zealand
facility: Teva Investigational Site 79059
city: South Hastings
country: New Zealand
facility: Teva Investigational Site 79060
city: Tauranga
country: New Zealand
facility: Teva Investigational Site 79052
city: Waikanae Beach
country: New Zealand
facility: Teva Investigational Site 79058
city: Wellington
country: New Zealand
facility: Teva Investigational Site 79050
city: Bialystok
country: Poland
facility: Teva Investigational Site 53531
city: Bialystok
country: Poland
facility: Teva Investigational Site 53527
city: Bydgoszcz
country: Poland
facility: Teva Investigational Site 53534
city: Elblag
country: Poland
facility: Teva Investigational Site 53537
city: Gdansk
country: Poland
facility: Teva Investigational Site 53524
city: Gdansk
country: Poland
facility: Teva Investigational Site 53538
city: Krakow
country: Poland
facility: Teva Investigational Site 53530
city: Krakow
country: Poland
facility: Teva Investigational Site 53521
city: Lodz
country: Poland
facility: Teva Investigational Site 53528
city: Lublin
country: Poland
facility: Teva Investigational Site 53523
city: Makow Podhalanski
country: Poland
facility: Teva Investigational Site 53522
city: Ostrowiec Swietokrzyski
country: Poland
facility: Teva Investigational Site 53525
city: Poznan
country: Poland
facility: Teva Investigational Site 53532
city: Rzeszow
country: Poland
facility: Teva Investigational Site 53526
city: Skierniewice
country: Poland
facility: Teva Investigational Site 53536
city: Warszawa
country: Poland
facility: Teva Investigational Site 53535
city: Zawadzkie
country: Poland
facility: Teva Investigational Site 53529
city: Bacau
country: Romania
facility: Teva Investigational Site 52139
city: Bragadiru
country: Romania
facility: Teva Investigational Site 52140
city: Bucuresti
country: Romania
facility: Teva Investigational Site 52138
city: Bucuresti
country: Romania
facility: Teva Investigational Site 52136
city: Cluj Napoca
country: Romania
facility: Teva Investigational Site 52135
city: Craiova
country: Romania
facility: Teva Investigational Site 52137
city: Belgrade
country: Serbia
facility: Teva Investigational Site 61071
city: Belgrade
country: Serbia
facility: Teva Investigational Site 61075
city: Belgrade
country: Serbia
facility: Teva Investigational Site 61076
city: Beograd
country: Serbia
facility: Teva Investigational Site 61073
city: Beograd
country: Serbia
facility: Teva Investigational Site 61074
city: Beograd
country: Serbia
facility: Teva Investigational Site 61080
city: Beograd
country: Serbia
facility: Teva Investigational Site 61077
city: Kragujevac
country: Serbia
facility: Teva Investigational Site 61078
city: Nis
country: Serbia
facility: Teva Investigational Site 61070
city: Novi Sad
country: Serbia
facility: Teva Investigational Site 61079
city: Sremska Kamenica
country: Serbia
facility: Teva Investigational Site 61072
city: Bardejov
country: Slovakia
facility: Teva Investigational Site 62083
city: Kosice
country: Slovakia
facility: Teva Investigational Site 62082
city: Rimavska Sobota
country: Slovakia
facility: Teva Investigational Site 62080
city: Slovakia
country: Slovakia
facility: Teva Investigational Site 62077
city: Spisska Nova Ves
country: Slovakia
facility: Teva Investigational Site 62078
city: Zilina
country: Slovakia
facility: Teva Investigational Site 62079
city: Zilina
country: Slovakia
facility: Teva Investigational Site 62081
city: Benoni
country: South Africa
facility: Teva Investigational Site 90078
city: Cape Town
country: South Africa
facility: Teva Investigational Site 90069
city: Cape Town
country: South Africa
facility: Teva Investigational Site 90077
city: Cape town
country: South Africa
facility: Teva Investigational Site 90063
city: Cape Town
country: South Africa
facility: Teva Investigational Site 90079
city: Chatsworth
country: South Africa
facility: Teva Investigational Site 90073
city: Durban
country: South Africa
facility: Teva Investigational Site 90067
city: Ennerdale
country: South Africa
facility: Teva Investigational Site 90070
city: Germiston
country: South Africa
facility: Teva Investigational Site 90083
city: Johannesburg
country: South Africa
facility: Teva Investigational Site 90062
city: Krugersdorp
country: South Africa
facility: Teva Investigational Site 90074
city: Middelburg
country: South Africa
facility: Teva Investigational Site 90064
city: Midrand
country: South Africa
facility: Teva Investigational Site 90072
city: Plettenberg Bay
country: South Africa
facility: Teva Investigational Site 90071
city: Polokwane
country: South Africa
facility: Teva Investigational Site 90081
city: Pretoria
country: South Africa
facility: Teva Investigational Site 90076
city: Raslouw
country: South Africa
facility: Teva Investigational Site 90080
city: Roodepoort
country: South Africa
facility: Teva Investigational Site 90068
city: Somerset West
country: South Africa
facility: Teva Investigational Site 90066
city: Stanger
country: South Africa
facility: Teva Investigational Site 90065
city: Barcelona
country: Spain
facility: Teva Investigational Site 31305
city: Barcelona
country: Spain
facility: Teva Investigational Site 31307
city: Cordoba
country: Spain
facility: Teva Investigational Site 31309
city: Madrid
country: Spain
facility: Teva Investigational Site 31303
city: Sabadell
country: Spain
facility: Teva Investigational Site 31310
city: Santiago de Compostela
country: Spain
facility: Teva Investigational Site 31306
city: Sevilla
country: Spain
facility: Teva Investigational Site 31311
city: Valencia
country: Spain
facility: Teva Investigational Site 31308
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: