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RECRUITING
NCT06664619
PHASE3

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

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

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.

Official title: A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Fluticasone Propionate/Albuterol Sulfate Combination Compared to Fluticasone Propionate, Albuterol Sulfate or Placebo Delivered by Multidose Dry Powder Inhaler in Participants 12 Years and Older With Asthma

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

724

Start Date

2024-12-12

Completion Date

2026-05-31

Last Updated

2026-04-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

Fp/ABS

Inhalation powder

DRUG

FP

Inhalation powder

DRUG

ABS

Inhalation powder

DRUG

Placebo

Inhalation powder

Locations (140)

Teva Investigational Site 12087

Phoenix, Arizona, United States

Teva Investigational Site 12144

Phoenix, Arizona, United States

Teva Investigational Site 12104

Tucson, Arizona, United States

Teva Investigational Site 12146

Tucson, Arizona, United States

Teva Investigational Site 12102

Little Rock, Arkansas, United States

Teva Investigational Site 12154

Encinitas, California, United States

Teva Investigational Site 12103

Huntington Beach, California, United States

Teva Investigational Site 12068

La Palma, California, United States

Teva Investigational Site 12152

Laguna Niguel, California, United States

Teva Investigational Site 12145

Long Beach, California, United States

Teva Investigational Site 12088

Los Angeles, California, United States

Teva Investigational Site 12094

Los Angeles, California, United States

Teva Investigational Site 12161

Northridge, California, United States

Teva Investigational Site 12105

Oxnard, California, United States

Teva Investigational Site 12101

Sacramento, California, United States

Teva Investigational Site 12064

San Jose, California, United States

Teva Investigational Site 12109

Upland, California, United States

Teva Investigational Site 12070

Vista, California, United States

Teva Investigational Site 12091

Walnut Creek, California, United States

Teva Investigational Site 12142

Lakewood, Colorado, United States

Teva Investigational Site 12098

Lake City, Florida, United States

Teva Investigational Site 12118

Lake Worth, Florida, United States

Teva Investigational Site 12079

Melbourne, Florida, United States

Teva Investigational Site 12071

Miami, Florida, United States

Teva Investigational Site 12074

Miami, Florida, United States

Teva Investigational Site 12086

Miami, Florida, United States

Teva Investigational Site 12061

Miami, Florida, United States

Teva Investigational Site 12097

Miami, Florida, United States

Teva Investigational Site 12092

Miami Lakes, Florida, United States

Teva Investigational Site 12076

North Miami Beach, Florida, United States

Teva Investigational Site 12095

Palmetto Bay, Florida, United States

Teva Investigational Site 12075

Pompano Beach, Florida, United States

Teva Investigational Site 12078

Tampa, Florida, United States

Teva Investigational Site 12175

Conyers, Georgia, United States

Teva Investigational Site 12156

Boise, Idaho, United States

Teva Investigational Site 12162

Westchester, Illinois, United States

Teva Investigational Site 12081

Nottingham, Maryland, United States

Teva Investigational Site 12106

Towson, Maryland, United States

Teva Investigational Site 12157

White Marsh, Maryland, United States

Teva Investigational Site 12119

Boston, Massachusetts, United States

Teva Investigational Site 12073

Minneapolis, Minnesota, United States

Teva Investigational Site 12066

Richfield, Minnesota, United States

Teva Investigational Site 12149

Columbia, Missouri, United States

Teva Investigational Site 12108

St Louis, Missouri, United States

Teva Investigational Site 12089

St Louis, Missouri, United States

Teva Investigational Site 12158

Hastings, Nebraska, United States

Teva Investigational Site 12160

Las Vegas, Nevada, United States

Teva Investigational Site 12150

Las Vegas, Nevada, United States

Teva Investigational Site 12110

Jersey City, New Jersey, United States

Teva Investigational Site 12115

Charlotte, North Carolina, United States

Teva Investigational Site 12085

Raleigh, North Carolina, United States

Teva Investigational Site 12063

Toledo, Ohio, United States

Teva Investigational Site 12155

Tulsa, Oklahoma, United States

Teva Investigational Site 12170

Tulsa, Oklahoma, United States

Teva Investigational Site 12117

Clackamas, Oregon, United States

Teva Investigational Site 12151

Portland, Oregon, United States

Teva Investigational Site 12147

Horsham, Pennsylvania, United States

Teva Investigational Site 12072

Philadelphia, Pennsylvania, United States

Teva Investigational Site 12114

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 12067

Columbia, South Carolina, United States

Teva Investigational Site 12111

Myrtle Beach, South Carolina, United States

Teva Investigational Site 12112

North Charleston, South Carolina, United States

Teva Investigational Site 12107

Rock Hill, South Carolina, United States

Teva Investigational Site 12083

Austin, Texas, United States

Teva Investigational Site 12060

Austin, Texas, United States

Teva Investigational Site 12077

Corsicana, Texas, United States

Teva Investigational Site 12159

Dallas, Texas, United States

Teva Investigational Site 12090

Dallas, Texas, United States

Teva Investigational Site 12143

El Paso, Texas, United States

Teva Investigational Site 12080

Kingwood, Texas, United States

Teva Investigational Site 12096

McKinney, Texas, United States

Teva Investigational Site 12113

Mesquite, Texas, United States

Teva Investigational Site 12084

Victoria, Texas, United States

Teva Investigational Site 12148

Pleasant View, Utah, United States

Teva Investigational Site 12082

Salt Lake City, Utah, United States

Teva Investigational Site 12153

South Ogden, Utah, United States

Teva Investigational Site 12093

Portsmouth, Virginia, United States

Teva Investigational Site 12062

Greenfield, Wisconsin, United States

Teva Investigational Site 20154

Buenos Aires, Argentina

Teva Investigational Site 20156

Buenos Aires, Argentina

Teva Investigational Site 20157

Córdoba, Argentina

Teva Investigational Site 20150

Córdoba, Argentina

Teva Investigational Site 20145

Mar del Plata, Argentina

Teva Investigational Site 20151

Mar del Plata, Argentina

Teva Investigational Site 20146

Quilmes, Argentina

Teva Investigational Site 20148

Rosario, Argentina

Teva Investigational Site 20155

Rosario, Argentina

Teva Investigational Site 20147

San Juan Bautista, Argentina

Teva Investigational Site 20152

San Miguel de Tucumán, Argentina

Teva Investigational Site 20149

San Miguel de Tucumán, Argentina

Teva Investigational Site 59248

Haskovo, Bulgaria

Teva Investigational Site 59251

Lovech, Bulgaria

Teva Investigational Site 59249

Montana, Bulgaria

Teva Investigational Site 59247

Pleven, Bulgaria

Teva Investigational Site 59256

Sliven, Bulgaria

Teva Investigational Site 59246

Sofia, Bulgaria

Teva Investigational Site 59252

Sofia, Bulgaria

Teva Investigational Site 59253

Sofia, Bulgaria

Teva Investigational Site 59245

Stara Zagora, Bulgaria

Teva Investigational Site 59254

Veliko Tarnovo, Bulgaria

Teva Investigational Site 59250

Vratsa, Bulgaria

Teva Investigational Site 54245

Jindřichův Hradec, Czechia

Teva Investigational Site 54244

Teplice, Czechia

Teva Investigational Site 54243

Varnsdorf, Czechia

Teva Investigational Site 32881

Ahrensburg, Germany

Teva Investigational Site 32880

Bendorf, Germany

Teva Investigational Site 32884

Berlin, Germany

Teva Investigational Site 32886

Berlin, Germany

Teva Investigational Site 32879

Frankfurt, Germany

Teva Investigational Site 32887

Leipzig, Germany

Teva Investigational Site 32883

Leipzig, Germany

Teva Investigational Site 32876

Leipzig, Germany

Teva Investigational Site 32877

Magdeburg, Germany

Teva Investigational Site 32878

Mainz A. Rhein, Germany

Teva Investigational Site 32888

Neu-Isenburg, Germany

Teva Investigational Site 32882

Rheine, Germany

Teva Investigational Site 80207

Be’er Ya‘aqov, Israel

Teva Investigational Site 80206

Haifa, Israel

Teva Investigational Site 80208

Jerusalem, Israel

Teva Investigational Site 21133

Chihuahua City, Mexico

Teva Investigational Site 21134

Mexico City, Mexico

Teva Investigational Site 21137

Morelia, Mexico

Teva Investigational Site 21136

Tlalnepantla, Mexico

Teva Investigational Site 21135

Zapopan, Mexico

Teva Investigational Site 53578

Gdansk, Poland

Teva Investigational Site 53575

Lodz, Poland

Teva Investigational Site 53576

Lodz, Poland

Teva Investigational Site 53579

Poznan, Poland

Teva Investigational Site 53574

Tarnów, Poland

Teva Investigational Site 53577

Wroclaw, Poland

Teva Investigational Site 52148

Craiova, Romania

Teva Investigational Site 52147

Oradea, Romania

Teva Investigational Site 52145

Timișoara, Romania

Teva Investigational Site 62102

Košice, Slovakia

Teva Investigational Site 62103

Martin, Slovakia

Teva Investigational Site 62101

Spišská Nová Ves, Slovakia

Teva Investigational Site 82089

Adana, Turkey (Türkiye)

Teva Investigational Site 82088

Kocaeli, Turkey (Türkiye)

Teva Investigational Site 82085

Kırıkkale, Turkey (Türkiye)

Teva Investigational Site 82087

Mersin, Turkey (Türkiye)