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NCT06664619PHASE3Recruiting

A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma

Teva Branded Pharmaceutical Products R&D LLC

Start Date

12/12/2024

Completion Date

9/19/2026

Summary

The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI). Secondary objectives are: * To evaluate the efficacy of Fp/ABS eMDPI administered four times daily * To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks * To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.

Eligibility Criteria

Age Range: 12 years to No maximum

Inclusion Criteria: * The participant has a diagnosis of asthma of at least 6 months duration. * Participants currently receive a beta-agonist (eg, salbutamol \[albuterol\] or ICS albuterol or ICS-formoterol) as rescue medication with or without asthma controller medication. * If female, a 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 trial), or is of non-childbearing potential. NOTE- Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * The participant has a history of life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest, hypoxic seizures or an asthma related syncopal episode. * The participant has had an upper or lower respiratory tract infection within 2 weeks or has had a confirmed case of COVID-19 within 6 weeks prior to Visit 1. Symptoms of the infection(s) must be completely resolved prior to entering 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, or any orally inhaled products including but not limited to cigarettes, beedis, vaping/ e-cigarettes, hookah/waterpipes, or marijuana. Note: participants with a positive urinary cotinine test will be excluded. * The participant has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, pulmonary fibrosis), or participants with a diagnosis of asthma COPD overlap syndrome. NOTE- Additional criteria apply, please contact the investigator for more information

Interventions

DRUG

Fp/ABS

DRUG

FP

DRUG

ABS

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Asthma

Locations

Teva Investigational Site 12087

Phoenix, Arizona 85015

United States

Teva Investigational Site 12144

Phoenix, Arizona 85020

United States

Teva Investigational Site 12104

Tucson, Arizona 85715

United States

Teva Investigational Site 12146

Tucson, Arizona 85741

United States

Teva Investigational Site 12102

Little Rock, Arkansas 72205

United States

Teva Investigational Site 12154

Encinitas, California 92024-2812

United States

Teva Investigational Site 12103

Huntington Beach, California 92647

United States

Teva Investigational Site 12068

La Palma, California 90623

United States

Teva Investigational Site 12152

Laguna Niguel, California 92677

United States

Teva Investigational Site 12145

Long Beach, California 90815

United States

Teva Investigational Site 12088

Los Angeles, California 90048

United States

Teva Investigational Site 12094

Los Angeles, California 93551

United States

Teva Investigational Site 12161

Northridge, California 91324

United States

Teva Investigational Site 12105

Oxnard, California 93030-5822

United States

Teva Investigational Site 12101

Sacramento, California 95821

United States

Teva Investigational Site 12064

San Jose, California 95117

United States

Teva Investigational Site 12109

Upland, California 91786

United States

Teva Investigational Site 12070

Vista, California 92083

United States

Teva Investigational Site 12091

Walnut Creek, California 94598

United States

Teva Investigational Site 12142

Lakewood, Colorado 80228

United States

Teva Investigational Site 12098

Lake City, Florida 32055-4880

United States

Teva Investigational Site 12118

Lake Worth, Florida 33460-4400

United States

Teva Investigational Site 12079

Melbourne, Florida 32934

United States

Teva Investigational Site 12071

Miami, Florida 33126

United States

Teva Investigational Site 12074

Miami, Florida 33135

United States

Teva Investigational Site 12086

Miami, Florida 33173

United States

Teva Investigational Site 12061

Miami, Florida 33174

United States

Teva Investigational Site 12097

Miami, Florida 33175

United States

Teva Investigational Site 12092

Miami Lakes, Florida 33014

United States

Teva Investigational Site 12076

North Miami Beach, Florida 33169

United States

Teva Investigational Site 12095

Palmetto Bay, Florida 33157

United States

Teva Investigational Site 12075

Pompano Beach, Florida 33064

United States

Teva Investigational Site 12078

Tampa, Florida 33607

United States

Teva Investigational Site 12175

Conyers, Georgia 30012

United States

Teva Investigational Site 12156

Boise, Idaho 83706

United States

Teva Investigational Site 12162

Westchester, Illinois 60154

United States

Teva Investigational Site 12169

Shreveport, Louisiana 71105

United States

Teva Investigational Site 12081

Nottingham, Maryland 21236

United States

Teva Investigational Site 12106

Towson, Maryland 21204

United States

Teva Investigational Site 12157

White Marsh, Maryland 21162-5503

United States

Teva Investigational Site 12119

Boston, Massachusetts 02115

United States

Teva Investigational Site 12182

South Dartmouth, Massachusetts 02747

United States

Teva Investigational Site 12073

Minneapolis, Minnesota 55402-2606

United States

Teva Investigational Site 12066

Richfield, Minnesota 55423

United States

Teva Investigational Site 12149

Columbia, Missouri 65203

United States

Teva Investigational Site 12108

St Louis, Missouri 63110

United States

Teva Investigational Site 12089

St Louis, Missouri 63141

United States

Teva Investigational Site 12158

Hastings, Nebraska 68901

United States

Teva Investigational Site 12160

Las Vegas, Nevada 89113

United States

Teva Investigational Site 12150

Las Vegas, Nevada 89119

United States

Teva Investigational Site 12110

Jersey City, New Jersey 07306

United States

Teva Investigational Site 12167

Buffalo, New York 14203

United States

Teva Investigational Site 12115

Charlotte, North Carolina 28207

United States

Teva Investigational Site 12085

Raleigh, North Carolina 27607-6689

United States

Teva Investigational Site 12063

Toledo, Ohio 43617

United States

Teva Investigational Site 12178

Oklahoma City, Oklahoma 73120

United States

Teva Investigational Site 12155

Tulsa, Oklahoma 74133

United States

Teva Investigational Site 12170

Tulsa, Oklahoma 74136

United States

Teva Investigational Site 12117

Clackamas, Oregon 97015

United States

Teva Investigational Site 12151

Portland, Oregon 97202

United States

Teva Investigational Site 12147

Horsham, Pennsylvania 19044

United States

Teva Investigational Site 12072

Philadelphia, Pennsylvania 19107

United States

Teva Investigational Site 12114

Pittsburgh, Pennsylvania 15241

United States

Teva Investigational Site 12067

Columbia, South Carolina 29204

United States

Teva Investigational Site 12111

Myrtle Beach, South Carolina 29572

United States

Teva Investigational Site 12112

North Charleston, South Carolina 29420

United States

Teva Investigational Site 12107

Rock Hill, South Carolina 29732

United States

Teva Investigational Site 12083

Austin, Texas 78744

United States

Teva Investigational Site 12060

Austin, Texas 78759

United States

Teva Investigational Site 12077

Corsicana, Texas 75110-2471

United States

Teva Investigational Site 12179

Cypress, Texas 77429

United States

Teva Investigational Site 12159

Dallas, Texas 75225-6301

United States

Teva Investigational Site 12171

Dallas, Texas 75235

United States

Teva Investigational Site 12090

Dallas, Texas 75243

United States

Teva Investigational Site 12143

El Paso, Texas 79912

United States

Teva Investigational Site 12181

Houston, Texas 77008-1528

United States

Teva Investigational Site 12168

Houston, Texas 77018

United States

Teva Investigational Site 12176

Kerrville, Texas 78028

United States

Teva Investigational Site 12080

Kingwood, Texas 77339

United States

Teva Investigational Site 12096

McKinney, Texas 75069

United States

Teva Investigational Site 12113

Mesquite, Texas 75150

United States

Teva Investigational Site 12166

Sugar Land, Texas 77479

United States

Teva Investigational Site 12084

Victoria, Texas 77901

United States

Teva Investigational Site 12148

Pleasant View, Utah 84404-4791

United States

Teva Investigational Site 12082

Salt Lake City, Utah 84123

United States

Teva Investigational Site 12153

South Ogden, Utah 84405

United States

Teva Investigational Site 12093

Portsmouth, Virginia 23703

United States

Teva Investigational Site 12062

Greenfield, Wisconsin 53228

United States

Teva Investigational Site 20154

Buenos Aires, C1426ABP

Argentina

Teva Investigational Site 20156

Buenos Aires, S2013DTC

Argentina

Teva Investigational Site 20157

Córdoba, X5003DCE

Argentina

Teva Investigational Site 20150

Córdoba, X5014AKM

Argentina

Teva Investigational Site 20160

Florida, B1602DQD

Argentina

Teva Investigational Site 20145

Mar del Plata, 7600

Argentina

Teva Investigational Site 20151

Mar del Plata, B7612ENA

Argentina

Teva Investigational Site 20161

Mendoza, 5500

Argentina

Teva Investigational Site 20146

Quilmes, 1878

Argentina

Teva Investigational Site 20148

Rosario, 2013

Argentina

Teva Investigational Site 20155

Rosario, S2000DEJ

Argentina

Teva Investigational Site 20147

San Juan Bautista, B1853AIK

Argentina

Teva Investigational Site 20152

San Miguel de Tucumán, 4000

Argentina

Teva Investigational Site 20159

San Miguel de Tucumán, 4000

Argentina

Teva Investigational Site 20149

San Miguel de Tucumán, T4000IFL

Argentina

Teva Investigational Site 20158

Santa Fe, S3000ASF

Argentina

Teva Investigational Site 59248

Haskovo, 6305

Bulgaria

Teva Investigational Site 59251

Lovech, 5500

Bulgaria

Teva Investigational Site 59249

Montana, 3400

Bulgaria

Teva Investigational Site 59258

Montana, 3400

Bulgaria

Teva Investigational Site 59247

Pleven, 5800

Bulgaria

Teva Investigational Site 59259

Rousse, 7002

Bulgaria

Teva Investigational Site 59256

Sliven, 8800

Bulgaria

Teva Investigational Site 59246

Sofia, 1142

Bulgaria

Teva Investigational Site 59252

Sofia, 1233

Bulgaria

Teva Investigational Site 59257

Sofia, 1421

Bulgaria

Teva Investigational Site 59253

Sofia, 5400

Bulgaria

Teva Investigational Site 59245

Stara Zagora, 6000

Bulgaria

Teva Investigational Site 59254

Veliko Tarnovo, 5000

Bulgaria

Teva Investigational Site 59250

Vratsa, 3000

Bulgaria

Teva Investigational Site 54247

Brandýs nad Labem, 25001

Czechia

Teva Investigational Site 54248

Brno, 618 00

Czechia

Teva Investigational Site 54245

Jindřichův Hradec, 37738

Czechia

Teva Investigational Site 54246

Prague, 148 00

Czechia

Teva Investigational Site 54249

Prague, 190 00

Czechia

Teva Investigational Site 54244

Teplice, 41501

Czechia

Teva Investigational Site 54243

Varnsdorf, 40747

Czechia

Teva Investigational Site 32881

Ahrensburg, 22926

Germany

Teva Investigational Site 32880

Bendorf, 56170

Germany

Teva Investigational Site 32884

Berlin, 10717

Germany

Teva Investigational Site 32886

Berlin, 10787

Germany

Teva Investigational Site 32893

Delitzsch, 04509

Germany

Teva Investigational Site 32879

Frankfurt, 60596

Germany

Teva Investigational Site 32892

Frankfurt, 60596

Germany

Teva Investigational Site 32887

Leipzig, 04177

Germany

Teva Investigational Site 32876

Leipzig, 04207

Germany

Teva Investigational Site 32883

Leipzig, 04347

Germany

Teva Investigational Site 32877

Magdeburg, 39120

Germany

Teva Investigational Site 32878

Mainz, 55128

Germany

Teva Investigational Site 32888

Neu-Isenburg, 63263

Germany

Teva Investigational Site 32890

Peine, 31224

Germany

Teva Investigational Site 32882

Rheine, 48431

Germany

Teva Investigational Site 32889

Witten, 58452

Germany

Teva Investigational Site 80207

Be'er Yaakov, 70300

Israel

Teva Investigational Site 80206

Haifa, 3109601

Israel

Teva Investigational Site 80208

Jerusalem, 91240

Israel

Teva Investigational Site 21133

Chihuahua City, 31203

Mexico

Teva Investigational Site 21134

Mexico City, 14090

Mexico

Teva Investigational Site 21137

Morelia, 58260

Mexico

Teva Investigational Site 21136

Tlalnepantla, 54055

Mexico

Teva Investigational Site 21135

Zapopan, 45138

Mexico

Teva Investigational Site 53582

Bialystok, 15-010

Poland

Teva Investigational Site 53580

Bialystok, 15-430

Poland

Teva Investigational Site 53578

Gdansk, 84-230

Poland

Teva Investigational Site 53575

Lodz, 90-127

Poland

Teva Investigational Site 53576

Lodz, 95-002

Poland

Teva Investigational Site 53581

Maków Podhalański, 34-220

Poland

Teva Investigational Site 53579

Poznan, 60-309

Poland

Teva Investigational Site 53574

Tarnów, 70-332

Poland

Teva Investigational Site 53577

Wroclaw, 50-381

Poland

Teva Investigational Site 52149

Bucharest, 077025

Romania

Teva Investigational Site 52148

Craiova, 410169

Romania

Teva Investigational Site 52147

Oradea, 410169

Romania

Teva Investigational Site 52145

Timișoara, 2447

Romania

Teva Investigational Site 61089

Belgrade, 11000

Serbia

Teva Investigational Site 61090

Belgrade, 11000

Serbia

Teva Investigational Site 61093

Belgrade, 11000

Serbia

Teva Investigational Site 61092

Belgrade, 11070

Serbia

Teva Investigational Site 61088

Belgrade, 11080

Serbia

Teva Investigational Site 61094

Kragujevac, 34000

Serbia

Teva Investigational Site 61096

Niš, 18 000

Serbia

Teva Investigational Site 61095

Novi Sad, 21000

Serbia

Teva Investigational Site 61091

Užice, 501715

Serbia

Teva Investigational Site 62102

Košice, 04022

Slovakia

Teva Investigational Site 62103

Martin, 03601

Slovakia

Teva Investigational Site 62101

Spišská Nová Ves, 05201

Slovakia

Teva Investigational Site 90099

Bellville, 7530

South Africa

Teva Investigational Site 90096

Pietermaritzburg, 944

South Africa

Teva Investigational Site 90098

Pretoria, 0157

South Africa

Teva Investigational Site 90105

Pretoria, 204

South Africa

Teva Investigational Site 90097

Vhembe, 1685

South Africa

Teva Investigational Site 82089

Adana, 1330

Turkey (Türkiye)

Teva Investigational Site 82085

Kirikkale, 71450

Turkey (Türkiye)

Teva Investigational Site 82088

Kocaeli, 41140

Turkey (Türkiye)

Teva Investigational Site 82087

Mersin, 33343

Turkey (Türkiye)