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

NCT ID: NCT06052267

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2026-07-17

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TEV-56248 Low Dose

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.

Group Type EXPERIMENTAL

TEV-56248

Intervention Type DRUG

Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.

TEV-56248 High Dose

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.

Group Type EXPERIMENTAL

TEV-56248

Intervention Type DRUG

Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.

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.

Group Type ACTIVE_COMPARATOR

Albuterol sulfate

Intervention Type DRUG

Oral inhalation powder

Interventions

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TEV-56248

Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.

Intervention Type DRUG

Albuterol sulfate

Oral inhalation powder

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 56013

Riga, , Latvia

Site Status RECRUITING

Teva Investigational Site 56020

Riga, , Latvia

Site Status RECRUITING

Teva Investigational Site 56018

Riga, , Latvia

Site Status RECRUITING

Teva Investigational Site 15786

Birmingham, Alabama, United States

Site Status RECRUITING

Teva Investigational Site 15768

Dothan, Alabama, United States

Site Status RECRUITING

Teva Investigational Site 15581

Paradise Valley, Arizona, United States

Site Status RECRUITING

Teva Investigational Site 15710

Scottsdale, Arizona, United States

Site Status RECRUITING

Teva Investigational Site 15661

Tucson, Arizona, United States

Site Status RECRUITING

Teva Investigational Site 15685

Bakersfield, California, United States

Site Status RECRUITING

Teva Investigational Site 15721

Fresno, California, United States

Site Status RECRUITING

Teva Investigational Site 15788

Huntington Beach, California, United States

Site Status RECRUITING

Teva Investigational Site 15720

La Jolla, California, United States

Site Status RECRUITING

Teva Investigational Site 15687

La Palma, California, United States

Site Status RECRUITING

Teva Investigational Site 15708

Long Beach, California, United States

Site Status RECRUITING

Teva Investigational Site 15712

Long Beach, California, United States

Site Status RECRUITING

Teva Investigational Site 15643

Los Angeles, California, United States

Site Status RECRUITING

Teva Investigational Site 15695

Napa, California, United States

Site Status RECRUITING

Teva Investigational Site 15692

Northridge, California, United States

Site Status RECRUITING

Teva Investigational Site 15682

Redondo Beach, California, United States

Site Status TERMINATED

Teva Investigational Site 15629

San Bernardino, California, United States

Site Status RECRUITING

Teva Investigational Site 15709

San Diego, California, United States

Site Status RECRUITING

Teva Investigational Site 15704

San Jose, California, United States

Site Status COMPLETED

Teva Investigational Site 15620

Stockton, California, United States

Site Status RECRUITING

Teva Investigational Site 15621

Westminster, California, United States

Site Status RECRUITING

Teva Investigational Site 15612

Aurora, Colorado, United States

Site Status TERMINATED

Teva Investigational Site 15588

Colorado Springs, Colorado, United States

Site Status RECRUITING

Teva Investigational Site 15765

Colorado Springs, Colorado, United States

Site Status RECRUITING

Teva Investigational Site 15676

Englewood, Colorado, United States

Site Status COMPLETED

Teva Investigational Site 15781

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Teva Investigational Site 15660

Aventura, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15624

Cape Coral, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15598

Cutler Bay, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15776

Doral, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15579

Greenacres City, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15582

Hialeah, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15664

Hialeah, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15657

Homestead, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15713

Jacksonville, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15632

Leesburg, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15777

Margate, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15602

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15722

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15724

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15655

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15605

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15634

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15596

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15654

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15773

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15652

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15585

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15639

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15645

Miami, Florida, United States

Site Status COMPLETED

Teva Investigational Site 15772

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15592

Miami, Florida, United States

Site Status TERMINATED

Teva Investigational Site 15769

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15644

Miami, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15589

Miami Lakes, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15599

Miami Lakes, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15595

Miami Lakes, Florida, United States

Site Status COMPLETED

Teva Investigational Site 15665

Oldsmar, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15659

Orlando, Florida, United States

Site Status COMPLETED

Teva Investigational Site 15617

Orlando, Florida, United States

Site Status TERMINATED

Teva Investigational Site 15625

Orlando, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15597

Pembroke Pines, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15767

Sweetwater, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15587

Tamarac, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15611

Tampa, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15619

Tampa, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15653

Tampa, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15606

Winter Park, Florida, United States

Site Status RECRUITING

Teva Investigational Site 15717

Atlanta, Georgia, United States

Site Status RECRUITING

Teva Investigational Site 15711

Conyers, Georgia, United States

Site Status RECRUITING

Teva Investigational Site 15626

Savannah, Georgia, United States

Site Status COMPLETED

Teva Investigational Site 15604

Boise, Idaho, United States

Site Status RECRUITING

Teva Investigational Site 15669

Chicago, Illinois, United States

Site Status RECRUITING

Teva Investigational Site 15616

Chicago, Illinois, United States

Site Status RECRUITING

Teva Investigational Site 15716

Chicago, Illinois, United States

Site Status RECRUITING

Teva Investigational Site 15600

Skokie, Illinois, United States

Site Status RECRUITING

Teva Investigational Site 15674

Evansville, Indiana, United States

Site Status RECRUITING

Teva Investigational Site 15580

Overland Park, Kansas, United States

Site Status TERMINATED

Teva Investigational Site 15627

Lexington, Kentucky, United States

Site Status RECRUITING

Teva Investigational Site 15770

Lafayette, Louisiana, United States

Site Status RECRUITING

Teva Investigational Site 15667

Bangor, Maine, United States

Site Status RECRUITING

Teva Investigational Site 15689

Rockville, Maryland, United States

Site Status TERMINATED

Teva Investigational Site 15583

White Marsh, Maryland, United States

Site Status RECRUITING

Teva Investigational Site 15628

Boston, Massachusetts, United States

Site Status RECRUITING

Teva Investigational Site 15686

Fall River, Massachusetts, United States

Site Status RECRUITING

Teva Investigational Site 15663

North Dartmouth, Massachusetts, United States

Site Status RECRUITING

Teva Investigational Site 15764

South Dartmouth, Massachusetts, United States

Site Status RECRUITING

Teva Investigational Site 15702

Detroit, Michigan, United States

Site Status RECRUITING

Teva Investigational Site 15701

Flint, Michigan, United States

Site Status TERMINATED

Teva Investigational Site 15593

Ypsilanti, Michigan, United States

Site Status RECRUITING

Teva Investigational Site 15648

Kansas City, Missouri, United States

Site Status RECRUITING

Teva Investigational Site 15640

St Louis, Missouri, United States

Site Status RECRUITING

Teva Investigational Site 15650

St Louis, Missouri, United States

Site Status TERMINATED

Teva Investigational Site 15633

St Louis, Missouri, United States

Site Status RECRUITING

Teva Investigational Site 15790

Hastings, Nebraska, United States

Site Status RECRUITING

Teva Investigational Site 15679

Las Vegas, Nevada, United States

Site Status TERMINATED

Teva Investigational Site 15725

North Bergen, New Jersey, United States

Site Status TERMINATED

Teva Investigational Site 15688

Hawthorne, New York, United States

Site Status RECRUITING

Teva Investigational Site 15603

Horseheads, New York, United States

Site Status TERMINATED

Teva Investigational Site 15666

Hyde Park, New York, United States

Site Status RECRUITING

Teva Investigational Site 15675

New Windsor, New York, United States

Site Status RECRUITING

Teva Investigational Site 15618

Asheville, North Carolina, United States

Site Status RECRUITING

Teva Investigational Site 15601

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Teva Investigational Site 15697

Charlotte, North Carolina, United States

Site Status RECRUITING

Teva Investigational Site 15610

Elizabeth City, North Carolina, United States

Site Status TERMINATED

Teva Investigational Site 15651

High Point, North Carolina, United States

Site Status RECRUITING

Teva Investigational Site 15771

Statesville, North Carolina, United States

Site Status COMPLETED

Teva Investigational Site 15631

Wilmington, North Carolina, United States

Site Status TERMINATED

Teva Investigational Site 15584

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Teva Investigational Site 15607

Cincinnati, Ohio, United States

Site Status RECRUITING

Teva Investigational Site 15613

Columbus, Ohio, United States

Site Status RECRUITING

Teva Investigational Site 15784

Dayton, Ohio, United States

Site Status RECRUITING

Teva Investigational Site 15791

Dayton, Ohio, United States

Site Status RECRUITING

Teva Investigational Site 15780

Toledo, Ohio, United States

Site Status RECRUITING

Teva Investigational Site 15662

Toledo, Ohio, United States

Site Status RECRUITING

Teva Investigational Site 15577

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Teva Investigational Site 15594

Tulsa, Oklahoma, United States

Site Status RECRUITING

Teva Investigational Site 15775

Yukon, Oklahoma, United States

Site Status RECRUITING

Teva Investigational Site 15646

Grants Pass, Oregon, United States

Site Status TERMINATED

Teva Investigational Site 15642

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Teva Investigational Site 15576

Pittsburgh, Pennsylvania, United States

Site Status COMPLETED

Teva Investigational Site 15608

North Charleston, South Carolina, United States

Site Status TERMINATED

Teva Investigational Site 15672

Rock Hill, South Carolina, United States

Site Status TERMINATED

Teva Investigational Site 15691

Knoxville, Tennessee, United States

Site Status RECRUITING

Teva Investigational Site 15705

Austin, Texas, United States

Site Status TERMINATED

Teva Investigational Site 15641

Boerne, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15778

Brownsville, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15668

Corsicana, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15658

Dallas, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15637

Dallas, Texas, United States

Site Status TERMINATED

Teva Investigational Site 15623

Dallas, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15785

Edinburg, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15678

El Paso, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15787

El Paso, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15591

El Paso, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15696

Houston, Texas, United States

Site Status COMPLETED

Teva Investigational Site 15714

Houston, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15680

Houston, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15614

Houston, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15578

Houston, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15690

Katy, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15684

Kerrville, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15630

McKinney, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15706

Plano, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15656

San Antonio, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15670

San Antonio, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15638

San Antonio, Texas, United States

Site Status TERMINATED

Teva Investigational Site 15647

Sherman, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15673

Splendora, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15707

Tomball, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15693

Victoria, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15649

Waxahachie, Texas, United States

Site Status RECRUITING

Teva Investigational Site 15671

Bountiful, Utah, United States

Site Status TERMINATED

Teva Investigational Site 15635

Sandy City, Utah, United States

Site Status COMPLETED

Teva Investigational Site 15789

West Valley City, Utah, United States

Site Status RECRUITING

Teva Investigational Site 15683

Williamsburg, Virginia, United States

Site Status RECRUITING

Teva Investigational Site 15586

Greenfield, Wisconsin, United States

Site Status RECRUITING

Teva Investigational Site 20126

Bahía Blanca, , Argentina

Site Status RECRUITING

Teva Investigational Site 20130

Bahía Blanca, , Argentina

Site Status RECRUITING

Teva Investigational Site 20109

Bahía Blanca, , Argentina

Site Status RECRUITING

Teva Investigational Site 20113

Buenos Aires, , Argentina

Site Status RECRUITING

Teva Investigational Site 20135

Buenos Aires, , Argentina

Site Status RECRUITING

Teva Investigational Site 20111

Buenos Aires, , Argentina

Site Status RECRUITING

Teva Investigational Site 20138

Buenos Aires, , Argentina

Site Status RECRUITING

Teva Investigational Site 20117

Buenos Aires Province, , Argentina

Site Status RECRUITING

Teva Investigational Site 20128

CABA, , Argentina

Site Status RECRUITING

Teva Investigational Site 20139

CABA, , Argentina

Site Status RECRUITING

Teva Investigational Site 20129

CapitalFederal, , Argentina

Site Status RECRUITING

Teva Investigational Site 20118

Concepción del Uruguay, , Argentina

Site Status RECRUITING

Teva Investigational Site 20106

Córdoba, , Argentina

Site Status RECRUITING

Teva Investigational Site 20125

Florida, Vicente Lopez, , Argentina

Site Status RECRUITING

Teva Investigational Site 20136

Godoy Cruz, , Argentina

Site Status RECRUITING

Teva Investigational Site 20122

Lanús Este, , Argentina

Site Status RECRUITING

Teva Investigational Site 20107

Lobos, , Argentina

Site Status RECRUITING

Teva Investigational Site 20123

Mar del Plata, , Argentina

Site Status RECRUITING

Teva Investigational Site 20121

Mendoza, , Argentina

Site Status RECRUITING

Teva Investigational Site 20115

Mendoza, , Argentina

Site Status RECRUITING

Teva Investigational Site 56014

Riga, , Latvia

Site Status RECRUITING

Teva Investigational Site 20110

Mendoza, , Argentina

Site Status RECRUITING

Teva Investigational Site 20127

Mendoza, , Argentina

Site Status RECRUITING

Teva Investigational Site 20140

Paraná, , Argentina

Site Status RECRUITING

Teva Investigational Site 20112

Quilmes, , Argentina

Site Status RECRUITING

Teva Investigational Site 20119

Rosario, , Argentina

Site Status RECRUITING

Teva Investigational Site 20105

Rosario, , Argentina

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Teva Investigational Site 20120

Rosario, , Argentina

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Teva Investigational Site 20133

San Fernando, , Argentina

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Teva Investigational Site 20114

San Juan Bautista, , Argentina

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Teva Investigational Site 20104

San Miguel de Tucumán, , Argentina

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Teva Investigational Site 20124

San Miguel de Tucumán, , Argentina

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Teva Investigational Site 20131

San Miguel de Tucumán, , Argentina

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Teva Investigational Site 20137

San Miguel de Tucumán, , Argentina

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Teva Investigational Site 20116

San Rafael, , Argentina

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Teva Investigational Site 20132

Santa Fe, , Argentina

Site Status RECRUITING

Teva Investigational Site 78131

Box Hill, , Australia

Site Status COMPLETED

Teva Investigational Site 78135

Clayton, , Australia

Site Status RECRUITING

Teva Investigational Site 78133

Melbourne, , Australia

Site Status RECRUITING

Teva Investigational Site 78132

Midland, , Australia

Site Status RECRUITING

Teva Investigational Site 78130

Nedlands, , Australia

Site Status TERMINATED

Teva Investigational Site 78134

North Adelaide, , Australia

Site Status RECRUITING

Teva Investigational Site 78128

Parkville, , Australia

Site Status RECRUITING

Teva Investigational Site 78127

South Brisbane, , Australia

Site Status RECRUITING

Teva Investigational Site 59230

Blagoevgrad, , Bulgaria

Site Status RECRUITING

Teva Investigational Site 59227

Kozloduy, , Bulgaria

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Teva Investigational Site 59218

Pernik, , Bulgaria

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Teva Investigational Site 59237

Pleven, , Bulgaria

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Teva Investigational Site 59222

Plovdiv, , Bulgaria

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Teva Investigational Site 59233

Plovdiv, , Bulgaria

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Teva Investigational Site 59219

Rousse, , Bulgaria

Site Status RECRUITING

Teva Investigational Site 59231

Sliven, , Bulgaria

Site Status RECRUITING

Teva Investigational Site 59224

Sofia, , Bulgaria

Site Status COMPLETED

Teva Investigational Site 59226

Sofia, , Bulgaria

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Teva Investigational Site 59235

Sofia, , Bulgaria

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Teva Investigational Site 59228

Sofia, , Bulgaria

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Teva Investigational Site 59234

Sofia, , Bulgaria

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Teva Investigational Site 59221

Sofia, , Bulgaria

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Teva Investigational Site 59220

Stara Zagora, , Bulgaria

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Teva Investigational Site 59232

Varna, , Bulgaria

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Teva Investigational Site 59229

Vratsa, , Bulgaria

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Teva Investigational Site 11267

Edmonton, Alberta, Canada

Site Status COMPLETED

Teva Investigational Site 11272

Ajax, Ontario, Canada

Site Status RECRUITING

Teva Investigational Site 11270

Etobicoke, Ontario, Canada

Site Status RECRUITING

Teva Investigational Site 11274

Hamilton, Ontario, Canada

Site Status RECRUITING

Teva Investigational Site 11271

Winchester, Ontario, Canada

Site Status TERMINATED

Teva Investigational Site 11273

Windsor, Ontario, Canada

Site Status RECRUITING

Teva Investigational Site 54231

Brandýs nad Labem-Stará Boleslav, , Czechia

Site Status RECRUITING

Teva Investigational Site 54232

Brno, , Czechia

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Teva Investigational Site 54229

Jihlava, , Czechia

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Teva Investigational Site 54226

Jindřichův Hradec, , Czechia

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Teva Investigational Site 54225

Lovosice, , Czechia

Site Status RECRUITING

Teva Investigational Site 54228

Ostrava, , Czechia

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Teva Investigational Site 54230

Prague, , Czechia

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Teva Investigational Site 54227

Varnsdorf, , Czechia

Site Status RECRUITING

Teva Investigational Site 39099

Aalborg, , Denmark

Site Status RECRUITING

Teva Investigational Site 39100

Hvidovre, , Denmark

Site Status TERMINATED

Teva Investigational Site 39098

Vejle, , Denmark

Site Status COMPLETED

Teva Investigational Site 32846

Augsburg, , Germany

Site Status RECRUITING

Teva Investigational Site 32835

Berlin, , Germany

Site Status RECRUITING

Teva Investigational Site 32834

Berlin, , Germany

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Teva Investigational Site 32833

Berlin, , Germany

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Teva Investigational Site 32840

Cottbus, , Germany

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Teva Investigational Site 32829

Darmstadt, , Germany

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Teva Investigational Site 32850

Delitzsch, , Germany

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Teva Investigational Site 32853

Essen, , Germany

Site Status RECRUITING

Teva Investigational Site 32831

Frankfurt, , Germany

Site Status RECRUITING

Teva Investigational Site 32845

Frankfurt am Main, , Germany

Site Status RECRUITING

Teva Investigational Site 32838

Hamburg, , Germany

Site Status TERMINATED

Teva Investigational Site 32827

Hamburg, , Germany

Site Status COMPLETED

Teva Investigational Site 32848

Hamburg, , Germany

Site Status RECRUITING

Teva Investigational Site 32841

Hanover, , Germany

Site Status COMPLETED

Teva Investigational Site 32842

Heidelberg, , Germany

Site Status RECRUITING

Teva Investigational Site 32851

Ibbenbueren, , Germany

Site Status RECRUITING

Teva Investigational Site 32844

Leipzig, , Germany

Site Status RECRUITING

Teva Investigational Site 32830

Leipzig - Nordost, , Germany

Site Status RECRUITING

Teva Investigational Site 32832

Mainz A. Rhein, , Germany

Site Status RECRUITING

Teva Investigational Site 32847

München, , Germany

Site Status RECRUITING

Teva Investigational Site 32828

München, , Germany

Site Status COMPLETED

Teva Investigational Site 32843

Neu-Isenburg, , Germany

Site Status RECRUITING

Teva Investigational Site 32839

Neuss, , Germany

Site Status COMPLETED

Teva Investigational Site 32836

Peine, , Germany

Site Status RECRUITING

Teva Investigational Site 32849

Wiesbaden, , Germany

Site Status RECRUITING

Teva Investigational Site 32852

Witten, , Germany

Site Status RECRUITING

Teva Investigational Site 63086

Athens, , Greece

Site Status COMPLETED

Teva Investigational Site 63085

Evros, , Greece

Site Status COMPLETED

Teva Investigational Site 63089

Heraklion, , Greece

Site Status RECRUITING

Teva Investigational Site 63087

Larissa, , Greece

Site Status RECRUITING

Teva Investigational Site 63082

Thessaloniki, , Greece

Site Status RECRUITING

Teva Investigational Site 63083

Thessaloniki, , Greece

Site Status RECRUITING

Teva Investigational Site 63088

Thivon and Livadias, , Greece

Site Status RECRUITING

Teva Investigational Site 51346

Budapest, , Hungary

Site Status TERMINATED

Teva Investigational Site 51344

Budapest, , Hungary

Site Status RECRUITING

Teva Investigational Site 51340

Budapest, , Hungary

Site Status RECRUITING

Teva Investigational Site 51342

Debrecen, , Hungary

Site Status TERMINATED

Teva Investigational Site 51345

Mosonmagyaróvár, , Hungary

Site Status RECRUITING

Teva Investigational Site 51343

Pécs, , Hungary

Site Status RECRUITING

Teva Investigational Site 51339

Szeged, , Hungary

Site Status RECRUITING

Teva Investigational Site 51341

Szigetvár, , Hungary

Site Status RECRUITING

Teva Investigational Site 80196

Ashkelon, , Israel

Site Status RECRUITING

Teva Investigational Site 80201

Beersheba, , Israel

Site Status RECRUITING

Teva Investigational Site 80200

Haifa, , Israel

Site Status RECRUITING

Teva Investigational Site 80194

Jerusalem, , Israel

Site Status RECRUITING

Teva Investigational Site 80198

Jerusalem, , Israel

Site Status RECRUITING

Teva Investigational Site 80199

Petach Tikvah, , Israel

Site Status RECRUITING

Teva Investigational Site 80195

Petah Tikva, , Israel

Site Status COMPLETED

Teva Investigational Site 80193

Rehovot, , Israel

Site Status RECRUITING

Teva Investigational Site 80197

Tel Aviv, , Israel

Site Status COMPLETED

Teva Investigational Site 30306

Ferrara, , Italy

Site Status RECRUITING

Teva Investigational Site 30316

Padua, , Italy

Site Status RECRUITING

Teva Investigational Site 30317

Pisa, , Italy

Site Status RECRUITING

Teva Investigational Site 30318

Verona, , Italy

Site Status RECRUITING

Teva Investigational Site 30307

Verona, , Italy

Site Status COMPLETED

Teva Investigational Site 56016

Balvi, , Latvia

Site Status RECRUITING

Teva Investigational Site 56019

Daugavpils, , Latvia

Site Status RECRUITING

Teva Investigational Site 56017

Jūrmala, , Latvia

Site Status RECRUITING

Teva Investigational Site 56015

Rēzekne, , Latvia

Site Status RECRUITING

Teva Investigational Site 21125

Chihuahua City, , Mexico

Site Status RECRUITING

Teva Investigational Site 21122

Guadalajara, , Mexico

Site Status RECRUITING

Teva Investigational Site 21127

Guadalajara, , Mexico

Site Status RECRUITING

Teva Investigational Site 21126

Monterrey, , Mexico

Site Status NOT_YET_RECRUITING

Teva Investigational Site 21123

Oaxaca City, , Mexico

Site Status RECRUITING

Teva Investigational Site 21129

Villahermosa, , Mexico

Site Status RECRUITING

Teva Investigational Site 79054

Auckland, , New Zealand

Site Status RECRUITING

Teva Investigational Site 79056

Auckland, , New Zealand

Site Status RECRUITING

Teva Investigational Site 79055

Christchurch, , New Zealand

Site Status TERMINATED

Teva Investigational Site 79057

Dunedin, , New Zealand

Site Status RECRUITING

Teva Investigational Site 79051

Hamilton, , New Zealand

Site Status RECRUITING

Teva Investigational Site 79062

Nawton, , New Zealand

Site Status COMPLETED

Teva Investigational Site 79061

Nelson, , New Zealand

Site Status COMPLETED

Teva Investigational Site 79059

Rotorua, , New Zealand

Site Status TERMINATED

Teva Investigational Site 79060

South Hastings, , New Zealand

Site Status TERMINATED

Teva Investigational Site 79052

Tauranga, , New Zealand

Site Status TERMINATED

Teva Investigational Site 79058

Waikanae Beach, , New Zealand

Site Status COMPLETED

Teva Investigational Site 79050

Wellington, , New Zealand

Site Status RECRUITING

Teva Investigational Site 53531

Bialystok, , Poland

Site Status RECRUITING

Teva Investigational Site 53527

Bialystok, , Poland

Site Status RECRUITING

Teva Investigational Site 53534

Bydgoszcz, , Poland

Site Status TERMINATED

Teva Investigational Site 53537

Elblag, , Poland

Site Status RECRUITING

Teva Investigational Site 53524

Gdansk, , Poland

Site Status RECRUITING

Teva Investigational Site 53538

Gdansk, , Poland

Site Status RECRUITING

Teva Investigational Site 53530

Krakow, , Poland

Site Status RECRUITING

Teva Investigational Site 53521

Krakow, , Poland

Site Status RECRUITING

Teva Investigational Site 53528

Lodz, , Poland

Site Status RECRUITING

Teva Investigational Site 53523

Lublin, , Poland

Site Status COMPLETED

Teva Investigational Site 53533

Lublin, , Poland

Site Status RECRUITING

Teva Investigational Site 53522

Maków Podhalański, , Poland

Site Status RECRUITING

Teva Investigational Site 53525

Ostrowiec Świętokrzyski, , Poland

Site Status RECRUITING

Teva Investigational Site 53532

Poznan, , Poland

Site Status RECRUITING

Teva Investigational Site 53526

Rzeszów, , Poland

Site Status RECRUITING

Teva Investigational Site 53536

Skierniewice, , Poland

Site Status RECRUITING

Teva Investigational Site 53535

Warsaw, , Poland

Site Status TERMINATED

Teva Investigational Site 53529

Zawadzkie, , Poland

Site Status RECRUITING

Teva Investigational Site 52139

Bacau, , Romania

Site Status RECRUITING

Teva Investigational Site 52140

Bragadiru, , Romania

Site Status RECRUITING

Teva Investigational Site 52138

Bucharest, , Romania

Site Status RECRUITING

Teva Investigational Site 52136

Bucharest, , Romania

Site Status RECRUITING

Teva Investigational Site 52135

Cluj-Napoca, , Romania

Site Status RECRUITING

Teva Investigational Site 52137

Craiova, , Romania

Site Status RECRUITING

Teva Investigational Site 61071

Belgrade, , Serbia

Site Status RECRUITING

Teva Investigational Site 61073

Belgrade, , Serbia

Site Status RECRUITING

Teva Investigational Site 61074

Belgrade, , Serbia

Site Status RECRUITING

Teva Investigational Site 61075

Belgrade, , Serbia

Site Status RECRUITING

Teva Investigational Site 61080

Belgrade, , Serbia

Site Status RECRUITING

Teva Investigational Site 61076

Belgrade, , Serbia

Site Status RECRUITING

Teva Investigational Site 61077

Belgrade, , Serbia

Site Status RECRUITING

Teva Investigational Site 61072

Kamenitz, , Serbia

Site Status RECRUITING

Teva Investigational Site 61078

Kragujevac, , Serbia

Site Status RECRUITING

Teva Investigational Site 61070

Niš, , Serbia

Site Status RECRUITING

Teva Investigational Site 61079

Novi Sad, , Serbia

Site Status RECRUITING

Teva Investigational Site 62083

Bardejov, , Slovakia

Site Status RECRUITING

Teva Investigational Site 62082

Košice, , Slovakia

Site Status TERMINATED

Teva Investigational Site 62080

Rimavská Sobota, , Slovakia

Site Status TERMINATED

Teva Investigational Site 62077

Slovakia, , Slovakia

Site Status RECRUITING

Teva Investigational Site 62078

Spišská Nová Ves, , Slovakia

Site Status RECRUITING

Teva Investigational Site 62079

Žilina, , Slovakia

Site Status RECRUITING

Teva Investigational Site 62081

Žilina, , Slovakia

Site Status RECRUITING

Teva Investigational Site 90078

Benoni, , South Africa

Site Status RECRUITING

Teva Investigational Site 90069

Cape Town, , South Africa

Site Status RECRUITING

Teva Investigational Site 90077

Cape Town, , South Africa

Site Status RECRUITING

Teva Investigational Site 90063

Cape Town, , South Africa

Site Status RECRUITING

Teva Investigational Site 90079

Cape Town, , South Africa

Site Status RECRUITING

Teva Investigational Site 90073

Chatsworth, , South Africa

Site Status TERMINATED

Teva Investigational Site 90067

Durban, , South Africa

Site Status RECRUITING

Teva Investigational Site 90070

Ennerdale, , South Africa

Site Status RECRUITING

Teva Investigational Site 90083

Germiston, , South Africa

Site Status RECRUITING

Teva Investigational Site 90062

Johannesburg, , South Africa

Site Status RECRUITING

Teva Investigational Site 90074

Krugersdorp, , South Africa

Site Status RECRUITING

Teva Investigational Site 90065

KwaDukuza, , South Africa

Site Status RECRUITING

Teva Investigational Site 90064

Middelburg, , South Africa

Site Status RECRUITING

Teva Investigational Site 90072

Midrand, , South Africa

Site Status RECRUITING

Teva Investigational Site 90071

Plettenberg Bay, , South Africa

Site Status COMPLETED

Teva Investigational Site 90081

Polokwane, , South Africa

Site Status TERMINATED

Teva Investigational Site 90076

Pretoria, , South Africa

Site Status RECRUITING

Teva Investigational Site 90080

Raslouw, , South Africa

Site Status RECRUITING

Teva Investigational Site 90068

Roodepoort, , South Africa

Site Status RECRUITING

Teva Investigational Site 90066

Somerset West, , South Africa

Site Status COMPLETED

Teva Investigational Site 90082

Soweto, , South Africa

Site Status RECRUITING

Teva Investigational Site 87039

Seoul, , South Korea

Site Status COMPLETED

Teva Investigational Site 87044

Seoul, , South Korea

Site Status TERMINATED

Teva Investigational Site 87043

Seoul, , South Korea

Site Status RECRUITING

Teva Investigational Site 87042

Seoul, , South Korea

Site Status RECRUITING

Teva Investigational Site 87040

Seoul, , South Korea

Site Status RECRUITING

Teva Investigational Site 87041

Seoul, , South Korea

Site Status RECRUITING

Teva Investigational Site 31304

Badalona, , Spain

Site Status RECRUITING

Teva Investigational Site 31305

Barcelona, , Spain

Site Status RECRUITING

Teva Investigational Site 31307

Barcelona, , Spain

Site Status RECRUITING

Teva Investigational Site 31309

Córdoba, , Spain

Site Status COMPLETED

Teva Investigational Site 31303

Madrid, , Spain

Site Status RECRUITING

Teva Investigational Site 31310

Sabadell, , Spain

Site Status RECRUITING

Teva Investigational Site 31306

Santiago de Compostela, , Spain

Site Status RECRUITING

Teva Investigational Site 31311

Seville, , Spain

Site Status RECRUITING

Teva Investigational Site 31308

Valencia, , Spain

Site Status COMPLETED

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Bulgaria Canada Czechia Denmark Germany Greece Hungary Israel Italy Latvia Mexico New Zealand Poland Romania Serbia Slovakia South Africa South Korea Spain

Central Contacts

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Teva U.S. Medical Information

Role: CONTACT

1-888-483-8279

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-505435-12-00

Identifier Type: OTHER

Identifier Source: secondary_id

FpA-AS-30094

Identifier Type: -

Identifier Source: org_study_id

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