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COMPLETED
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 LLC

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

649

Start Date

2024-12-12

Completion Date

2026-10-26

Last Updated

2026-11-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

Fp/ABS

Inhalation powder

DRUG

FP

Inhalation powder

DRUG

ABS

Inhalation powder

DRUG

Placebo

Inhalation powder

Locations (189)

Arizona Medical Clinic

Phoenix, Arizona, United States

Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Del Sol Research Management

Tucson, Arizona, United States

Novak Clinical Research

Tucson, Arizona, United States

Acuro Research, Inc

Little Rock, Arkansas, United States

Office Of Dr. Warren W. Pleskow MD

Encinitas, California, United States

Allergy and Asthma Specialist Medical Group and Research Center

Huntington Beach, California, United States

IMAX Clinical Trials

La Palma, California, United States

Allergy and Asthma Associates of Southern California

Laguna Niguel, California, United States

Ark Clinical Research

Long Beach, California, United States

Southern California Institute for Respiratory Diseases

Los Angeles, California, United States

California Allergy and Asthma Medical Group, Inc.

Los Angeles, California, United States

California Medical Research Associates Inc.

Northridge, California, United States

FOMAT Medical Research

Oxnard, California, United States

Northern California Research

Sacramento, California, United States

Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California, United States

Integrated Research of lnland, Inc.

Upland, California, United States

Synexus Clinical Research US, Inc.

Vista, California, United States

Allergy & Asthma Clinical Research, Inc.

Walnut Creek, California, United States

Critical Care, Pulmonary and Sleep Associates

Lakewood, Colorado, United States

Multi-Specialty Research Associates, Inc.

Lake City, Florida, United States

3Sync, LLC

Lake Worth, Florida, United States

Optimal Research

Melbourne, Florida, United States

Angels Clinical Research Institute

Miami, Florida, United States

Suncoast Research Group LLC - Flourish

Miami, Florida, United States

Innova Pharma Research

Miami, Florida, United States

Florida Research Center, Inc.

Miami, Florida, United States

Diverse Clinical Research, LLC

Miami, Florida, United States

San Marcus Research Clinic Inc

Miami Lakes, Florida, United States

Oceanic Research Group, LLC

North Miami Beach, Florida, United States

Innovation Medical Research Center - Alcanza

Palmetto Bay, Florida, United States

D&H Pompano Research Center

Pompano Beach, Florida, United States

Clinical Research Trials of Florida, Inc

Tampa, Florida, United States

Oracle Clinical Research

Conyers, Georgia, United States

Treasure Valley Medical Research

Boise, Idaho, United States

Axis Clinical Research

Westchester, Illinois, United States

Care Access - Shreveport

Shreveport, Louisiana, United States

Patient First Clinical Trials

Nottingham, Maryland, United States

Continental Clinical Research Solutions, LLC

Towson, Maryland, United States

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayflower Clinical Research

South Dartmouth, Massachusetts, United States

Bolt Clinical Research,LLC

Brighton, Michigan, United States

Clinical Research Institute, Inc

Minneapolis, Minnesota, United States

Synexus Clinical Research US, Inc.

Richfield, Minnesota, United States

Clinical Research of the Ozarks Inc

Columbia, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

The Clinical Research Center, LLC

St Louis, Missouri, United States

Family Medical Center of Hastings

Hastings, Nebraska, United States

Las Vegas Clinical Research Unit

Las Vegas, Nevada, United States

Santa Rosa Medical Centers of Nevada Avacare

Las Vegas, Nevada, United States

Focus Clinical Research Solutions

Jersey City, New Jersey, United States

American Health Research, Inc.

Charlotte, North Carolina, United States

Peters Medical Research, LLC

High Point, North Carolina, United States

North Carolina Clinical Research - CRN

Raleigh, North Carolina, United States

Toledo Institute of Clinical Research

Toledo, Ohio, United States

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, United States

Layrek Clinical Research

Tulsa, Oklahoma, United States

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

Portland Allergy and Asthma

Clackamas, Oregon, United States

Northwest Research Center

Portland, Oregon, United States

Hatboro Medical Associates - Avacare

Horsham, Pennsylvania, United States

DM Clinical Research

Philadelphia, Pennsylvania, United States

Allergy and Clinical Immunology Associates Pittsburgh

Pittsburgh, Pennsylvania, United States

Velocity Clinical Research - Columbia

Columbia, South Carolina, United States

Trial Management Associates LLC - Myrtle Beach

Myrtle Beach, South Carolina, United States

National Allergy and Asthma Research LLC.

North Charleston, South Carolina, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

PPD Clinical Research

Austin, Texas, United States

Orion Clinical Research

Austin, Texas, United States

Corsicana Medical Research

Corsicana, Texas, United States

Horizon Clinical Research Group

Cypress, Texas, United States

Alina Clinical Trials, LLC, Barbara Baxter Sole MBR

Dallas, Texas, United States

Southwest Family Medicine Associates

Dallas, Texas, United States

Lonestar Clinical Research

Dallas, Texas, United States

Western Sky Medical Research

El Paso, Texas, United States

Greater Heights Memorial Pulmonary and Sleep

Houston, Texas, United States

SFF Research Group

Houston, Texas, United States

Innovative Medical Research of Texas LLC

Houston, Texas, United States

Sante Clinical Research LLC

Kerrville, Texas, United States

3Sync Research - Houston

Kingwood, Texas, United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States

Epic Medical Research

Mesquite, Texas, United States

Siena Research Network

Sugar Land, Texas, United States

DM Clinical Tomball

Tomball, Texas, United States

Victoria Clinical Research Group

Victoria, Texas, United States

Ogden Clinic - Mountain View

Pleasant View, Utah, United States

Synexus Clinical Research US, Inc.

Salt Lake City, Utah, United States

South Ogden Family Medicine - Avacare

South Ogden, Utah, United States

Velocity Clinical Research - Family Practice - Suffolk

Portsmouth, Virginia, United States

Allergy, Asthma & Sinus Center, S.C.

Greenfield, Wisconsin, United States

Consultorios Medicos Dr. Doreski - PPDS

Buenos Aires, Argentina

Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias

Buenos Aires, Argentina

Instituto de Medicina Respiratoria, IMeR

Córdoba, Argentina

Hospital de Ninos de La Santisima Trinidad

Córdoba, Argentina

CEMER Centro Medico de Enfermedades Respiratorias

Florida, Argentina

Instituto Ave Pulmo

Mar del Plata, Argentina

Centro de Investigaciones Medicas Mar del Plata (CIM-MDP)

Mar del Plata, Argentina

Fundacion Scherbovsky

Mendoza, Argentina

Centro Respiratorio Quilmes

Quilmes, Argentina

And 89 more locations on ClinicalTrials.gov