AzTrials
AzTrials

AsthmaPhase 3NCT06052267

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

A Phase 3 study testing TEV-56248 and Albuterol sulfate in people with Asthma, run by Teva Branded Pharmaceutical Products R&D LLC at 393 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs). Read more about this study

Who is it for?
Ages 4 years and older
Conditions the study is for
Asthma
What is being tested?
TEV-56248 and Albuterol sulfate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,772 participants
Where
393 sitesin 22 countries
Study dates
30 Aug 2023to 31 Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

393 sites in 22 countries.

393 sites in 22 countries

United States157 sites

  • Teva Investigational Site 15618

    Asheville, North Carolina, 28803

  • Teva Investigational Site 15717

    Atlanta, Georgia, 30329

  • Teva Investigational Site 15612

    Aurora, Colorado, 80014

  • Teva Investigational Site 15705

    Austin, Texas, 78759

  • Teva Investigational Site 15660

    Aventura, Florida, 33180

  • Teva Investigational Site 15685

    Bakersfield, California, 93301

  • Teva Investigational Site 15667

    Bangor, Maine, 04401

  • Teva Investigational Site 15706

    Birmingham, Alabama, 35209

  • Teva Investigational Site 15786

    Birmingham, Alabama, 35233

  • Teva Investigational Site 15641

    Boerne, Texas, 78006

  • Teva Investigational Site 15604

    Boise, Idaho, 83706

  • Teva Investigational Site 15628

    Boston, Massachusetts, 02115

  • Teva Investigational Site 15671

    Bountiful, Utah, 84010

  • Teva Investigational Site 15778

    Brownsville, Texas, 78520

  • Teva Investigational Site 15624

    Cape Coral, Florida, 33914

  • Teva Investigational Site 15601

    Chapel Hill, North Carolina, 27599

  • Teva Investigational Site 15697

    Charlotte, North Carolina, 28277

  • Teva Investigational Site 15669

    Chicago, Illinois, 60607

  • Teva Investigational Site 15616

    Chicago, Illinois, 60612

  • Teva Investigational Site 15716

    Chicago, Illinois, 60637

  • Teva Investigational Site 15607

    Cincinnati, Ohio, 45236

  • Teva Investigational Site 15588

    Colorado Springs, Colorado, 80907

  • Teva Investigational Site 15765

    Colorado Springs, Colorado, 80922

  • Teva Investigational Site 15613

    Columbus, Ohio, 43205

  • Teva Investigational Site 15711

    Conyers, Georgia, 30012

  • Teva Investigational Site 15668

    Corsicana, Texas, 75110

  • Teva Investigational Site 15598

    Cutler Bay, Florida, 33189

  • Teva Investigational Site 15658

    Dallas, Texas, 75209

  • Teva Investigational Site 15637

    Dallas, Texas, 75231-8206

  • Teva Investigational Site 15623

    Dallas, Texas, 75235

  • Teva Investigational Site 15784

    Dayton, Ohio, 45404

  • Teva Investigational Site 15791

    Dayton, Ohio, 45429

  • Teva Investigational Site 15702

    Detroit, Michigan, 48202

  • Teva Investigational Site 15776

    Doral, Florida, 33122

  • Teva Investigational Site 15768

    Dothan, Alabama, 36305

  • Teva Investigational Site 15785

    Edinburg, Texas, 78539

  • Teva Investigational Site 15678

    El Paso, Texas, 79902

  • Teva Investigational Site 15787

    El Paso, Texas, 79902

  • Teva Investigational Site 15591

    El Paso, Texas, 79912

  • Teva Investigational Site 15610

    Elizabeth City, North Carolina, 27909-3465

  • Teva Investigational Site 15676

    Englewood, Colorado, 80110

  • Teva Investigational Site 15674

    Evansville, Indiana, 47715

  • Teva Investigational Site 15686

    Fall River, Massachusetts, 02723

  • Teva Investigational Site 15701

    Flint, Michigan, 48507

  • Teva Investigational Site 15721

    Fresno, California, 93704

  • Teva Investigational Site 15646

    Grants Pass, Oregon, 97527

  • Teva Investigational Site 15579

    Greenacres City, Florida, 33476

  • Teva Investigational Site 15586

    Greenfield, Wisconsin, 53228

  • Teva Investigational Site 15790

    Hastings, Nebraska, 68901

  • Teva Investigational Site 15688

    Hawthorne, New York, 10532

  • Teva Investigational Site 15582

    Hialeah, Florida, 33012

  • Teva Investigational Site 15664

    Hialeah, Florida, 33012

  • Teva Investigational Site 15651

    High Point, North Carolina, 27260

  • Teva Investigational Site 15657

    Homestead, Florida, 33030

  • Teva Investigational Site 15603

    Horseheads, New York, 14845

  • Teva Investigational Site 15696

    Houston, Texas, 77008

  • Teva Investigational Site 15714

    Houston, Texas, 77030

  • Teva Investigational Site 15680

    Houston, Texas, 77065

  • Teva Investigational Site 15614

    Houston, Texas, 77074-2005

  • Teva Investigational Site 15578

    Houston, Texas, 77099

  • Teva Investigational Site 15788

    Huntington Beach, California, 92647-6853

  • Teva Investigational Site 15666

    Hyde Park, New York, 11042

  • Teva Investigational Site 15713

    Jacksonville, Florida, 32207

  • Teva Investigational Site 15648

    Kansas City, Missouri, 66160

  • Teva Investigational Site 15690

    Katy, Texas, 77494

  • Teva Investigational Site 15684

    Kerrville, Texas, 78028

  • Teva Investigational Site 15691

    Knoxville, Tennessee, 37909

  • Teva Investigational Site 15720

    La Jolla, California, 92037

  • Teva Investigational Site 15687

    La Palma, California, 90623

  • Teva Investigational Site 15770

    Lafayette, Louisiana, 70508

  • Teva Investigational Site 15679

    Las Vegas, Nevada, 89123-2875

  • Teva Investigational Site 15632

    Leesburg, Florida, 34748

  • Teva Investigational Site 15627

    Lexington, Kentucky, 40509

  • Teva Investigational Site 15708

    Long Beach, California, 90806-2613

  • Teva Investigational Site 15712

    Long Beach, California, 90815

  • Teva Investigational Site 15643

    Los Angeles, California, 90025

  • Teva Investigational Site 15777

    Margate, Florida, 33063

  • Teva Investigational Site 15630

    McKinney, Texas, 75069

  • Teva Investigational Site 15602

    Miami, Florida, 33126

  • Teva Investigational Site 15722

    Miami, Florida, 33126

  • Teva Investigational Site 15724

    Miami, Florida, 33126

  • Teva Investigational Site 15655

    Miami, Florida, 33130

  • Teva Investigational Site 15605

    Miami, Florida, 33142-2946

  • Teva Investigational Site 15634

    Miami, Florida, 33143

  • Teva Investigational Site 15596

    Miami, Florida, 33144

  • Teva Investigational Site 15654

    Miami, Florida, 33144

  • Teva Investigational Site 15773

    Miami, Florida, 33155

  • Teva Investigational Site 15585

    Miami, Florida, 33173

  • Teva Investigational Site 15639

    Miami, Florida, 33173

  • Teva Investigational Site 15645

    Miami, Florida, 33173

  • Teva Investigational Site 15772

    Miami, Florida, 33175

  • Teva Investigational Site 15592

    Miami, Florida, 33176

  • Teva Investigational Site 15769

    Miami, Florida, 33176

  • Teva Investigational Site 15644

    Miami, Florida, 33186

  • Teva Investigational Site 15589

    Miami Lakes, Florida, 33014

  • Teva Investigational Site 15599

    Miami Lakes, Florida, 33014

  • Teva Investigational Site 15595

    Miami Lakes, Florida, 33016

  • Teva Investigational Site 15695

    Napa, California, 94558

  • Teva Investigational Site 15675

    New Windsor, New York, 12553

  • Teva Investigational Site 15725

    North Bergen, New Jersey, 07047

  • Teva Investigational Site 15608

    North Charleston, South Carolina, 29420

  • Teva Investigational Site 15663

    North Dartmouth, Massachusetts, 02747

  • Teva Investigational Site 15692

    Northridge, California, 91324

  • Teva Investigational Site 15577

    Oklahoma City, Oklahoma, 73120-9389

  • Teva Investigational Site 15665

    Oldsmar, Florida, 34677

  • Teva Investigational Site 15659

    Orlando, Florida, 32806

  • Teva Investigational Site 15617

    Orlando, Florida, 32819

  • Teva Investigational Site 15625

    Orlando, Florida, 32825

  • Teva Investigational Site 15580

    Overland Park, Kansas, 66210

  • Teva Investigational Site 15581

    Paradise Valley, Arizona, 85258

  • Teva Investigational Site 15597

    Pembroke Pines, Florida, 33025

  • Teva Investigational Site 15642

    Philadelphia, Pennsylvania, 19140

  • Teva Investigational Site 15576

    Pittsburgh, Pennsylvania, 15241

  • Teva Investigational Site 15682

    Redondo Beach, California, 90277-5720

  • Teva Investigational Site 15672

    Rock Hill, South Carolina, 29732

  • Teva Investigational Site 15689

    Rockville, Maryland, 20852

  • Teva Investigational Site 15656

    San Antonio, Texas, 78212

  • Teva Investigational Site 15670

    San Antonio, Texas, 78229

  • Teva Investigational Site 15638

    San Antonio, Texas, 78258

  • Teva Investigational Site 15629

    San Bernardino, California, 92408

  • Teva Investigational Site 15709

    San Diego, California, 92120

  • Teva Investigational Site 15704

    San Jose, California, 95117

  • Teva Investigational Site 15635

    Sandy City, Utah, 84093

  • Teva Investigational Site 15626

    Savannah, Georgia, 31406-2668

  • Teva Investigational Site 15710

    Scottsdale, Arizona, 85259

  • Teva Investigational Site 15647

    Sherman, Texas, 75090

  • Teva Investigational Site 15600

    Skokie, Illinois, 60077

  • Teva Investigational Site 15764

    South Dartmouth, Massachusetts, 02747

  • Teva Investigational Site 15673

    Splendora, Texas, 77372

  • Teva Investigational Site 15640

    St Louis, Missouri, 63110

  • Teva Investigational Site 15650

    St Louis, Missouri, 63123

  • Teva Investigational Site 15633

    St Louis, Missouri, 63141-7068

  • Teva Investigational Site 15771

    Statesville, North Carolina, 28625

  • Teva Investigational Site 15620

    Stockton, California, 95207

  • Teva Investigational Site 15767

    Sweetwater, Florida, 33182

  • Teva Investigational Site 15587

    Tamarac, Florida, 33321

  • Teva Investigational Site 15611

    Tampa, Florida, 33604

  • Teva Investigational Site 15619

    Tampa, Florida, 33607-6327

  • Teva Investigational Site 15653

    Tampa, Florida, 33607

  • Teva Investigational Site 15780

    Toledo, Ohio, 43606

  • Teva Investigational Site 15662

    Toledo, Ohio, 43617

  • Teva Investigational Site 15707

    Tomball, Texas, 77081

  • Teva Investigational Site 15661

    Tucson, Arizona, 85741

  • Teva Investigational Site 15594

    Tulsa, Oklahoma, 74133

  • Teva Investigational Site 15693

    Victoria, Texas, 77901

  • Teva Investigational Site 15652

    Virginia Gardens, Florida, 33166

  • Teva Investigational Site 15781

    Washington D.C., District of Columbia, 20009

  • Teva Investigational Site 15649

    Waxahachie, Texas, 75165-1430

  • Teva Investigational Site 15789

    West Valley City, Utah, 84119

  • Teva Investigational Site 15621

    Westminster, California, 92683

  • Teva Investigational Site 15583

    White Marsh, Maryland, 21162

  • Teva Investigational Site 15683

    Williamsburg, Virginia, 23188

  • Teva Investigational Site 15631

    Wilmington, North Carolina, 28401

  • Teva Investigational Site 15584

    Winston-Salem, North Carolina, 27157

  • Teva Investigational Site 15606

    Winter Park, Florida, 32789

  • Teva Investigational Site 15593

    Ypsilanti, Michigan, 48197

  • Teva Investigational Site 15775

    Yukon, Oklahoma, 73099

Other trials in United States

Argentina35 sites

  • Teva Investigational Site 20126

    Bahía Blanca, B8000JRB

  • Teva Investigational Site 20130

    Bahía Blanca, B8001AAD

  • Teva Investigational Site 20109

    Bahía Blanca, B8001DDU

  • Teva Investigational Site 20113

    Buenos Aires, C1121ABE

  • Teva Investigational Site 20135

    Buenos Aires, C1128AAF

  • Teva Investigational Site 20129

    Buenos Aires, C1425BEN

  • Teva Investigational Site 20111

    Buenos Aires, C1426ABP

  • Teva Investigational Site 20138

    Buenos Aires, C1426ABP

  • Teva Investigational Site 20128

    CABA, 1414

  • Teva Investigational Site 20139

    CABA, C1426ABP

  • Teva Investigational Site 20118

    Concepción del Uruguay, 3260

  • Teva Investigational Site 20106

    Córdoba, X5003DCE

  • Teva Investigational Site 20125

    Florida, B1602DQD

  • Teva Investigational Site 20136

    Godoy Cruz, 5501

  • Teva Investigational Site 20122

    Lanus, 1824

  • Teva Investigational Site 20107

    Lobos, B7240KJB

  • Teva Investigational Site 20117

    Mar del Plata, 7600

  • Teva Investigational Site 20123

    Mar del Plata, B7612ENA

  • Teva Investigational Site 20121

    Mendoza, 5500

  • Teva Investigational Site 20115

    Mendoza, M55000CBA

  • Teva Investigational Site 20110

    Mendoza, M5500CCA

  • Teva Investigational Site 20127

    Mendoza, M5507XAF

  • Teva Investigational Site 20140

    Paraná, E3100XAI

  • Teva Investigational Site 20112

    Quilmes, 1878

  • Teva Investigational Site 20119

    Rosario, 2000

  • Teva Investigational Site 20105

    Rosario, S2000 DEJ

  • Teva Investigational Site 20120

    Rosario, S2000JKR

  • Teva Investigational Site 20133

    San Fernando, B1646EBJ

  • Teva Investigational Site 20114

    San Juan Bautista, 1888

  • Teva Investigational Site 20104

    San Miguel de Tucumán, 4000

  • Teva Investigational Site 20124

    San Miguel de Tucumán, 4000

  • Teva Investigational Site 20131

    San Miguel de Tucumán, 4000

  • Teva Investigational Site 20137

    San Miguel de Tucumán, T4000EGH

  • Teva Investigational Site 20116

    San Rafael, M5602GGS

  • Teva Investigational Site 20132

    Santa Fe, S3000ASF

Other trials in Argentina

Germany26 sites

  • Teva Investigational Site 32846

    Augsburg, 86150

  • Teva Investigational Site 32835

    Berlin, 10119

  • Teva Investigational Site 32834

    Berlin, 10717

  • Teva Investigational Site 32833

    Berlin, 12159

  • Teva Investigational Site 32840

    Cottbus, D-03050

  • Teva Investigational Site 32829

    Darmstadt, 65283

  • Teva Investigational Site 32850

    Delitzsch, 4509

  • Teva Investigational Site 32853

    Essen, 45239

  • Teva Investigational Site 32831

    Frankfurt, 60596

  • Teva Investigational Site 32845

    Frankfurt am Main, 60596

  • Teva Investigational Site 32838

    Hamburg, 20354

  • Teva Investigational Site 32827

    Hamburg, 22299

  • Teva Investigational Site 32848

    Hamburg, 22335

  • Teva Investigational Site 32841

    Hanover, 30449

  • Teva Investigational Site 32851

    Ibbenbueren, 49477

  • Teva Investigational Site 32842

    Karlsruhe, D-76137

  • Teva Investigational Site 32830

    Leipzig, 04347

  • Teva Investigational Site 32844

    Leipzig, 4299

  • Teva Investigational Site 32832

    Mainz, 55128

  • Teva Investigational Site 32847

    München, 80539

  • Teva Investigational Site 32828

    München, 81241

  • Teva Investigational Site 32843

    Neu-Isenburg, 63623

  • Teva Investigational Site 32839

    Neuss, 41469

  • Teva Investigational Site 32836

    Peine, 31224

  • Teva Investigational Site 32849

    Wiesbaden, 65189

  • Teva Investigational Site 32852

    Witten, 58452

Other trials in Germany

South Africa21 sites

  • Teva Investigational Site 90078

    Benoni, 1501

  • Teva Investigational Site 90069

    Cape Town, 7530

  • Teva Investigational Site 90077

    Cape Town, 7530

  • Teva Investigational Site 90063

    Cape Town, 7570

  • Teva Investigational Site 90079

    Cape Town, 7700

  • Teva Investigational Site 90080

    Centurion, 0157

  • Teva Investigational Site 90073

    Chatsworth, 4092

  • Teva Investigational Site 90067

    Durban, 4092

  • Teva Investigational Site 90070

    Ennerdale, 1830

  • Teva Investigational Site 90083

    Germiston, 1401

  • Teva Investigational Site 90062

    Johannesburg, 2113

  • Teva Investigational Site 90074

    Krugersdorp, 1739

  • Teva Investigational Site 90065

    KwaDukuza, 4450

  • Teva Investigational Site 90064

    Middelburg, 1050

  • Teva Investigational Site 90072

    Midrand, 1685

  • Teva Investigational Site 90071

    Plettenberg Bay, 6600

  • Teva Investigational Site 90081

    Polokwane, 699

  • Teva Investigational Site 90076

    Pretoria, 0181

  • Teva Investigational Site 90068

    Roodepoort, 1724

  • Teva Investigational Site 90066

    Somerset West, 7130

  • Teva Investigational Site 90082

    Soweto, 1868

Other trials in South Africa

Poland18 sites

  • Teva Investigational Site 53531

    Bialystok, 15-010

  • Teva Investigational Site 53527

    Bialystok, 15-430

  • Teva Investigational Site 53534

    Bydgoszcz, 85-796

  • Teva Investigational Site 53537

    Elblag, 82-300

  • Teva Investigational Site 53524

    Gdansk, 80-214

  • Teva Investigational Site 53538

    Gdansk, 80-344

  • Teva Investigational Site 53530

    Krakow, 31-141

  • Teva Investigational Site 53521

    Krakow, 31-624

  • Teva Investigational Site 53528

    Lodz, 93-513

  • Teva Investigational Site 53523

    Lublin, 20-089

  • Teva Investigational Site 53533

    Lublin, 20-095

  • Teva Investigational Site 53522

    Maków Podhalański, 34-220

  • Teva Investigational Site 53525

    Ostrowiec Świętokrzyski, 27-400

  • Teva Investigational Site 53532

    Poznan, 60-693

  • Teva Investigational Site 53526

    Rzeszów, 35-051

  • Teva Investigational Site 53536

    Skierniewice, 96-100

  • Teva Investigational Site 53535

    Warsaw, 00-632

  • Teva Investigational Site 53529

    Zawadzkie, 47-120

Other trials in Poland

Bulgaria17 sites

  • Teva Investigational Site 59230

    Blagoevgrad, 2700

  • Teva Investigational Site 59227

    Kozloduy, 3320

  • Teva Investigational Site 59218

    Pernik, 2300

  • Teva Investigational Site 59237

    Pleven, 5800

  • Teva Investigational Site 59222

    Plovdiv, 4002

  • Teva Investigational Site 59233

    Plovdiv, 4002

  • Teva Investigational Site 59219

    Rousse, 7002

  • Teva Investigational Site 59231

    Sliven, 8800

  • Teva Investigational Site 59224

    Sofia, 1142

  • Teva Investigational Site 59226

    Sofia, 1407

  • Teva Investigational Site 59235

    Sofia, 1408

  • Teva Investigational Site 59228

    Sofia, 1421

  • Teva Investigational Site 59234

    Sofia, 1431

  • Teva Investigational Site 59221

    Sofia, 1680

  • Teva Investigational Site 59220

    Stara Zagora, 6001

  • Teva Investigational Site 59232

    Varna, 9000

  • Teva Investigational Site 59229

    Vratsa, 3001

Other trials in Bulgaria

New Zealand12 sites

  • Teva Investigational Site 79054

    Auckland, 1010

  • Teva Investigational Site 79056

    Auckland, 626

  • Teva Investigational Site 79055

    Christchurch, 8013

  • Teva Investigational Site 79057

    Dunedin, 9016

  • Teva Investigational Site 79062

    Hamilton, 3200

  • Teva Investigational Site 79051

    Hamilton, 3204

  • Teva Investigational Site 79060

    Hastings, 4122

  • Teva Investigational Site 79061

    Nelson, 7011

  • Teva Investigational Site 79059

    Rotorua, 3010

  • Teva Investigational Site 79052

    Tauranga, 3110

  • Teva Investigational Site 79058

    Waikanae Beach, 5036

  • Teva Investigational Site 79050

    Wellington, 6021

Other trials in New Zealand

Serbia11 sites

  • Teva Investigational Site 61071

    Belgrade, 11000

  • Teva Investigational Site 61073

    Belgrade, 11000

  • Teva Investigational Site 61074

    Belgrade, 11000

  • Teva Investigational Site 61075

    Belgrade, 11000

  • Teva Investigational Site 61080

    Belgrade, 11000

  • Teva Investigational Site 61076

    Belgrade, 11070

  • Teva Investigational Site 61077

    Belgrade, 11080

  • Teva Investigational Site 61072

    Kamenitz, 21204

  • Teva Investigational Site 61078

    Kragujevac, 34000

  • Teva Investigational Site 61070

    Niš, 18000

  • Teva Investigational Site 61079

    Novi Sad, 21000

Other trials in Serbia

Israel9 sites

  • Teva Investigational Site 80196

    Ashkelon, 7830604

  • Teva Investigational Site 80201

    Beersheba, 8457108

  • Teva Investigational Site 80200

    Haifa, 3109601

  • Teva Investigational Site 80194

    Jerusalem, 9103102

  • Teva Investigational Site 80198

    Jerusalem, 9112010

  • Teva Investigational Site 80199

    Petach Tikvah, 4920235

  • Teva Investigational Site 80195

    Petah Tikva, 4941492

  • Teva Investigational Site 80193

    Rehovot, 7661041

  • Teva Investigational Site 80197

    Tel Aviv, 6423906

Other trials in Israel

Spain9 sites

  • Teva Investigational Site 31304

    Badalona, 8916

  • Teva Investigational Site 31305

    Barcelona, 08017

  • Teva Investigational Site 31307

    Barcelona, 08035

  • Teva Investigational Site 31309

    Córdoba, 14004

  • Teva Investigational Site 31303

    Madrid, 28007

  • Teva Investigational Site 31310

    Sabadell, 8208

  • Teva Investigational Site 31306

    Santiago de Compostela, 15706

  • Teva Investigational Site 31311

    Seville, 41013

  • Teva Investigational Site 31308

    Valencia, 46015

Other trials in Spain

Australia8 sites

  • Teva Investigational Site 78131

    Box Hill, 3128

  • Teva Investigational Site 78135

    Clayton, 3168

  • Teva Investigational Site 78133

    Melbourne, 3004

  • Teva Investigational Site 78132

    Midland, 6056

  • Teva Investigational Site 78130

    Nedlands, 6009

  • Teva Investigational Site 78134

    North Adelaide, 5006

  • Teva Investigational Site 78128

    Parkville, 3052

  • Teva Investigational Site 78127

    South Brisbane, 4101

Other trials in Australia

Czechia8 sites

  • Teva Investigational Site 54231

    Brandýs nad Labem-Stará Boleslav, 25001

  • Teva Investigational Site 54232

    Brno, 60200

  • Teva Investigational Site 54229

    Jihlava, 586 01

  • Teva Investigational Site 54226

    Jindřichův Hradec, 37701

  • Teva Investigational Site 54225

    Lovosice, 410 02

  • Teva Investigational Site 54228

    Ostrava, 70900

  • Teva Investigational Site 54230

    Prague, 148 00

  • Teva Investigational Site 54227

    Varnsdorf, 40747

Other trials in Czechia

Hungary8 sites

  • Teva Investigational Site 51346

    Budapest, 1027

  • Teva Investigational Site 51344

    Budapest, 1033

  • Teva Investigational Site 51340

    Budapest, 1094

  • Teva Investigational Site 51342

    Debrecen, 4027

  • Teva Investigational Site 51345

    Mosonmagyaróvár, 9200

  • Teva Investigational Site 51343

    Pécs, 7635

  • Teva Investigational Site 51339

    Szeged, 6720

  • Teva Investigational Site 51341

    Szigetvár, 7900

Other trials in Hungary

Latvia8 sites

  • Teva Investigational Site 56016

    Balvi, LV-4501

  • Teva Investigational Site 56019

    Daugavpils, LV-5417

  • Teva Investigational Site 56017

    Jūrmala, LV-2015

  • Teva Investigational Site 56015

    Rēzekne, 4601

  • Teva Investigational Site 56014

    Riga, 1004

  • Teva Investigational Site 56013

    Riga, LV-1003

  • Teva Investigational Site 56020

    Riga, LV-1004

  • Teva Investigational Site 56018

    Riga, LV1010

Other trials in Latvia

Greece7 sites

  • Teva Investigational Site 63085

    Alexandroupoli, 68100

  • Teva Investigational Site 63086

    Athens, 10675

  • Teva Investigational Site 63088

    Athens, 11527

  • Teva Investigational Site 63089

    Heraklion, 71500

  • Teva Investigational Site 63087

    Larissa, 41 110

  • Teva Investigational Site 63082

    Thessaloniki, 54639

  • Teva Investigational Site 63083

    Thessaloniki, 57 010

Other trials in Greece

Slovakia7 sites

  • Teva Investigational Site 62083

    Bardejov, 08501

  • Teva Investigational Site 62077

    Kežmarok, 06224

  • Teva Investigational Site 62082

    Košice, 040 11

  • Teva Investigational Site 62080

    Rimavská Sobota, 979 01

  • Teva Investigational Site 62078

    Spišská Nová Ves, 052 01

  • Teva Investigational Site 62079

    Žilina, 01001

  • Teva Investigational Site 62081

    Žilina, 1001

Other trials in Slovakia

Canada6 sites

  • Teva Investigational Site 11272

    Ajax, Ontario, l1s2j5

  • Teva Investigational Site 11267

    Edmonton, Alberta, T6G2G3

  • Teva Investigational Site 11270

    Etobicoke, Ontario, M9V 4B4

  • Teva Investigational Site 11274

    Hamilton, Ontario, L8S 1G5

  • Teva Investigational Site 11271

    Winchester, Ontario, K0C 2K0

  • Teva Investigational Site 11273

    Windsor, Ontario, N8X 2G1

Other trials in Canada

Mexico6 sites

  • Teva Investigational Site 21125

    Chihuahua City, 31203

  • Teva Investigational Site 21122

    Guadalajara, 44100

  • Teva Investigational Site 21127

    Guadalajara, 44670

  • Teva Investigational Site 21126

    Monterrey, 64460

  • Teva Investigational Site 21123

    Oaxaca City, 68000

  • Teva Investigational Site 21129

    Villahermosa, 86035

Other trials in Mexico

Romania6 sites

  • Teva Investigational Site 52139

    Bacau, 600625

  • Teva Investigational Site 52140

    Bragadiru, 769764

  • Teva Investigational Site 52138

    Bucharest, 12052

  • Teva Investigational Site 52136

    Bucharest, 41507

  • Teva Investigational Site 52135

    Cluj-Napoca, 400371

  • Teva Investigational Site 52137

    Craiova, 200515

Other trials in Romania

South Korea6 sites

  • Teva Investigational Site 87039

    Seoul, 04763

  • Teva Investigational Site 87044

    Seoul, 1757

  • Teva Investigational Site 87043

    Seoul, 3312

  • Teva Investigational Site 87042

    Seoul, 3722

  • Teva Investigational Site 87040

    Seoul, 5505

  • Teva Investigational Site 87041

    Seoul, 6591

Other trials in South Korea

Italy5 sites

  • Teva Investigational Site 30306

    Ferrara, 44124

  • Teva Investigational Site 30316

    Padova, 35128

  • Teva Investigational Site 30317

    Pisa, 56126

  • Teva Investigational Site 30318

    Verona, 37131

  • Teva Investigational Site 30307

    Verona, 37134

Other trials in Italy

Denmark3 sites

  • Teva Investigational Site 39099

    Aalborg, 9100

  • Teva Investigational Site 39100

    Hvidovre, 2650

  • Teva Investigational Site 39098

    Vejle, 7100

Other trials in Denmark

About this study

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

The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs).

Secondary Objectives:

Read more

To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure

To evaluate the safety and tolerability of Fp/A BS

The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria

Conditions
Asthma
Being tested
TEV-56248, Albuterol sulfate
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEV-56248Drug

    Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.

  • Albuterol sulfateDrug

    Oral inhalation powder

Study groups in NCT06052267
Study groupRoleWhat they receive
TEV-56248 30/117 mcgExperimentalInhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Receives: Drug: TEV-56248
TEV-56248 55/117 mcgExperimentalInhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Receives: Drug: TEV-56248
Albuterol sulfate 117 mcgActive comparatorInhalation powder via multidose dry powder inhaler with integrated electronic module (eMDPI) with a dosing frequency of 2 inhalations as needed to control asthma symptoms.
Receives: Drug: Albuterol sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI

    Measured: Up to 42 months

Secondary outcomes (8)

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

    Measured: Up to 42 months

  2. Annualized Severe CAE Rate

    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).

    Measured: Up to 42 months

  3. Total Annualized SCS Exposure Over the Treatment Period

    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.

    Measured: Up to 42 months

  4. Asthma Control Questionnaire-5 (ACQ-5) Response

    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.

    Measured: Baseline, Week 24

  5. Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ)

    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.

    Measured: Baseline, Week 24

  6. Number of Participants with at Least One Adverse Event

    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.

    Measured: Up to 42 months

  7. Number of Participants with at Least One Serious Adverse Event

    Measured: Up to 42 months

  8. Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events

    Measured: Up to 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start30 Aug 2023
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,772 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06052267
Sponsor's protocol ID
FpA-AS-30094
Other IDs
2023-505435-12-00, 2023
Status last verified
Oct 2026
First submitted
18 Sep 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TEV-56248 and Albuterol sulfate in people with Asthma, run by Teva Branded Pharmaceutical Products R&D LLC at 393 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 393 sites in United States, Argentina, Germany, South Africa, Poland and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI (time frame: Up to 42 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06052267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in