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A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
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). Secondary Objectives: 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
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
Key Details
Gender
All
Age Range
4 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2769
Start Date
2023-08-30
Completion Date
2026-12-31
Last Updated
2026-11-04
Healthy Volunteers
No
Conditions
Interventions
TEV-56248
Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Albuterol sulfate
Oral inhalation powder
Locations (391)
AllerVie Clnical Research
Birmingham, Alabama, United States
The University of Alabama at Birmingham
Birmingham, Alabama, United States
SEC Clinical Research
Dothan, Alabama, United States
One of a Kind Clinical Research Center LLC
Paradise Valley, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Novak Clinical Research
Tucson, Arizona, United States
Kern Research, Inc
Bakersfield, California, United States
Clinical Research of Central California, LLC
Fresno, California, United States
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, United States
Orso Health
La Jolla, California, United States
IMAX Clinical Trials
La Palma, California, United States
Long Beach Clinical Trials
Long Beach, California, United States
Ark Clinical Research, LLC
Long Beach, California, United States
Ricardo Antonio Tan Inc
Los Angeles, California, United States
One of a Kind Clinical Research Center LLC
Napa, California, United States
California Medical Research Associates Inc.
Northridge, California, United States
Riviera Allergy Medical Center
Redondo Beach, California, United States
Velocity Clinical Research, Banning
San Bernardino, California, United States
Institute of HealthCare Assessment, Inc
San Diego, California, United States
Allergy and Asthma Associates
San Jose, California, United States
Bensch Clinical Research LLC
Stockton, California, United States
Allianz Research Institute
Westminster, California, United States
Allianz Research Institute
Aurora, Colorado, United States
CRN Clinical Research Network LLC/Asthma and Allergy Associates P.C.
Colorado Springs, Colorado, United States
OptumCare Colorado Springs LLC
Colorado Springs, Colorado, United States
Velocity Clinical Research
Englewood, Colorado, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
Florida Center for Allergy and Asthma Research
Aventura, Florida, United States
Renaissance Research and Medical Group
Cape Coral, Florida, United States
Cenara Clinical Research
Cutler Bay, Florida, United States
D & H Doral Research Centers
Doral, Florida, United States
Finlay Medical Research Corp
Greenacres City, Florida, United States
Direct Helpers Research Center, Inc.
Hialeah, Florida, United States
New Life Research Institute, LLC
Hialeah, Florida, United States
Homestead Medical Research
Homestead, Florida, United States
Nemours Children Clinic
Jacksonville, Florida, United States
Clinical Site Partner, LLC DBA Flourish Research
Leesburg, Florida, United States
D & H Pompano Research Centers, Inc.
Margate, Florida, United States
EMDA Clinical Research
Miami, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Life Arc Research Centers
Miami, Florida, United States
Care Research Center
Miami, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Florida Pharmaceutical Research and Associates
Miami, Florida, United States
Bio-Medical Research LLC
Miami, Florida, United States
Y&L Advance Health Care, Inc. d/b/a Elite Clinical Research
Miami, Florida, United States
D & H National Research Centers, Inc.
Miami, Florida, United States
Advance Medical Research Practice
Miami, Florida, United States
Century Research LLC
Miami, Florida, United States
Florida Center for Allergy and Asthma Research
Miami, Florida, United States
ITB Research
Miami, Florida, United States
DY Professional Research Center
Miami, Florida, United States
IMIC INC
Miami, Florida, United States
Phoenix Research Center, LLC
Miami, Florida, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States
The Research Center
Miami Lakes, Florida, United States
Quality Research of South Florida
Miami Lakes, Florida, United States
Journey Research Inc.
Oldsmar, Florida, United States
Anderson Allergy And Asthma, PA
Orlando, Florida, United States
HMD Research LLC
Orlando, Florida, United States
AHMG Pulmonology at East Orlando
Orlando, Florida, United States
Pines Care Research Center LLC
Pembroke Pines, Florida, United States
Cordova Research Institute, LLC
Sweetwater, Florida, United States
TBC Research Corp
Tamarac, Florida, United States
Wecare research center LLC
Tampa, Florida, United States
Clinical Research Trials of Florida, Inc.
Tampa, Florida, United States
Nodal Medical Center, Llc
Tampa, Florida, United States
Hope Research Network/CBS Laboratory
Virginia Gardens, Florida, United States
Florida Pediatric Research Institute
Winter Park, Florida, United States
Children's Healthcare of Atlanta Center for Advanced Pediatrics
Atlanta, Georgia, United States
Oracle Clinical Research
Conyers, Georgia, United States
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Northshore University Health System Clinical Trials Center
Skokie, Illinois, United States
Deaconess Clinic
Evansville, Indiana, United States
Velocity Clinical Research, Kansas City
Overland Park, Kansas, United States
Bluegrass Allergy Research
Lexington, Kentucky, United States
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, United States
Paul A. Shapero M.D.
Bangor, Maine, United States
DelRicht Research @ Matthew Mintz Clinic
Rockville, Maryland, United States
Chesapeake Clinical Research Inc
White Marsh, Maryland, United States
Brigham Womens Hospital
Boston, Massachusetts, United States
Exordia Medical Research Inc,
Fall River, Massachusetts, United States
Infinity Medical Research
North Dartmouth, Massachusetts, United States
Mayflower Clinical Research
South Dartmouth, Massachusetts, United States
Henry Ford
Detroit, Michigan, United States
Onyx Clinical Research
Flint, Michigan, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, United States
University of Kansas School of Medicine
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Clayton Sleep Institute
St Louis, Missouri, United States
Midwest Clinical Research
St Louis, Missouri, United States
Family Medical Center of Hastings
Hastings, Nebraska, United States
American Institute of Medical Research
Las Vegas, Nevada, United States
Northern Valley Allergy, Asthma & Sinus Center
North Bergen, New Jersey, United States
New York Medical College
Hawthorne, New York, United States
Corning Center for Clinical Research
Horseheads, New York, United States