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

Purpose

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.

Condition

  • Asthma

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Fp/ABS eMDPI 		Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module
  • Drug: Fp/ABS
    Inhalation powder
    Other names:
    • fluticasone propionate/albuterol sulfate combination
Active Comparator
Fp eMDPI 		Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)
  • Drug: FP
    Inhalation powder
    Other names:
    • fluticasone propionate
Active Comparator
ABS eMDPI 		Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)
  • Drug: Fp/ABS
    Inhalation powder
    Other names:
    • fluticasone propionate/albuterol sulfate combination
  • Drug: ABS
    Inhalation powder
    Other names:
    • albuterol sulfate
Placebo Comparator
Placebo eMDPI
  • Drug: Placebo
    Inhalation powder

Recruiting Locations

Teva Investigational Site 12087
Phoenix, Arizona 85015

Teva Investigational Site 12144
Phoenix, Arizona 85020

Teva Investigational Site 12104
Tucson, Arizona 85715

Teva Investigational Site 12102
Little Rock, Arkansas 72205

Teva Investigational Site 12103
Huntington Beach, California 92647

Teva Investigational Site 12068
La Palma, California 90623

Teva Investigational Site 12088
Los Angeles, California 90048

Teva Investigational Site 12094
Los Angeles, California 93551

Teva Investigational Site 12105
Oxnard, California 93003

Teva Investigational Site 12101
Sacramento, California 95821

Teva Investigational Site 12064
San Jose, California 95117

Teva Investigational Site 12109
Upland, California 91786

Teva Investigational Site 12091
Walnut Creek, California 94598

Teva Investigational Site 12142
Lakewood, Colorado 80228

Teva Investigational Site 12098
Lake City, Florida 32055

Teva Investigational Site 12118
Lake Worth, Florida 33406

Teva Investigational Site 12079
Melbourne, Florida 32934

Teva Investigational Site 12071
Miami, Florida 33126

Teva Investigational Site 12074
Miami, Florida 33135

Teva Investigational Site 12086
Miami, Florida 33173

Teva Investigational Site 12061
Miami, Florida 33174

Teva Investigational Site 12097
Miami, Florida 33175

Teva Investigational Site 12076
North Miami Beach, Florida 33169

Teva Investigational Site 12095
Palmetto Bay, Florida 33157

Teva Investigational Site 12075
Pompano Beach, Florida 33064

Teva Investigational Site 12078
Tampa, Florida 33607

Teva Investigational Site 12081
Nottingham, Maryland 21236

Teva Investigational Site 12106
Towson, Maryland 21204

Teva Investigational Site 12073
Minneapolis, Minnesota 55402

Teva Investigational Site 12066
Richfield, Minnesota 55423

Teva Investigational Site 12089
Saint Louis, Missouri 63141

Teva Investigational Site 12110
Jersey City, New Jersey 07306

Teva Investigational Site 12115
Charlotte, North Carolina 28207

Teva Investigational Site 12085
Raleigh, North Carolina 27607

Teva Investigational Site 12063
Toledo, Ohio 43617

Teva Investigational Site 12117
Clackamas, Oregon 97015

Teva Investigational Site 12072
Philadelphia, Pennsylvania 19107

Teva Investigational Site 12114
Pittsburgh, Pennsylvania 15241

Teva Investigational Site 12067
Columbia, South Carolina 29204

Teva Investigational Site 12111
Myrtle Beach, South Carolina 29572

Teva Investigational Site 12112
North Charleston, South Carolina 29420

Teva Investigational Site 12107
Rock Hill, South Carolina 29732

Teva Investigational Site 12083
Austin, Texas 78744

Teva Investigational Site 12060
Austin, Texas 78759

Teva Investigational Site 12077
Corsicana, Texas 75110-2471

Teva Investigational Site 12090
Dallas, Texas 75203

Teva Investigational Site 12143
El Paso, Texas 79925

Teva Investigational Site 12080
Kingwood, Texas 77339

Teva Investigational Site 12084
Victoria, Texas 77901

Teva Investigational Site 12093
Portsmouth, Virginia 23703

Teva Investigational Site 12062
Greenfield, Wisconsin 53228

More Details

NCT ID
NCT06664619
Status
Recruiting
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

Study Contact

Teva U.S. Medical Information
1-888-483-8279
USMedInfo@tevapharm.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center