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

Last updated: March 20, 2025
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Asthma

Treatment

ABS

FP

Placebo

Clinical Study ID

NCT06664619
FpA-AS-30093
2024-517991-39-00
  • Ages > 12
  • All Genders

Study 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

Inclusion

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 ICSalbuterol or ICS-formoterol) as rescue medication with or without asthma controllermedication.

  • If female, a participant is currently not pregnant, breastfeeding, or attempting tobecome pregnant (for at least 30 days before the screening visit and throughout theduration of the trial), or is of non-childbearing potential.

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion

Exclusion Criteria:

  • The participant has a history of life-threatening asthma defined as any history ofsignificant 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 weeksor has had a confirmed case of COVID-19 within 6 weeks prior to Visit 1. Symptoms ofthe 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 historyof smoking. A current smoker is defined as any participant who has used any form oftobacco product (including oral) within the past 6 months, or any orally inhaledproducts including but not limited to cigarettes, beedis, vaping/ e-cigarettes,hookah/waterpipes, or marijuana. Note: participants with a positive urinary cotininetest will be excluded.

  • The participant has another confounding underlying lung disorder (eg, chronicobstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasiswith the need of treatment, cystic fibrosis, pulmonary fibrosis), or participantswith a diagnosis of asthma COPD overlap syndrome.

NOTE- Additional criteria apply, please contact the investigator for more information

Study Design

Total Participants: 724
Treatment Group(s): 4
Primary Treatment: ABS
Phase: 3
Study Start date:
December 12, 2024
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Teva Investigational Site 12144

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Teva Investigational Site 12103

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Teva Investigational Site 12068

    La Palma, California 90623
    United States

    Active - Recruiting

  • Teva Investigational Site 12094

    Los Angeles, California 93551
    United States

    Active - Recruiting

  • Teva Investigational Site 12105

    Oxnard, California 93003
    United States

    Active - Recruiting

  • Teva Investigational Site 12064

    San Jose, California 95117
    United States

    Active - Recruiting

  • Teva Investigational Site 12070

    Vista, California 92083
    United States

    Active - Recruiting

  • Teva Investigational Site 12091

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Teva Investigational Site 12098

    Lake City, Florida 32055
    United States

    Active - Recruiting

  • Teva Investigational Site 12079

    Melbourne, Florida 32934
    United States

    Active - Recruiting

  • Teva Investigational Site 12061

    Miami, Florida 33174
    United States

    Active - Recruiting

  • Teva Investigational Site 12071

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Teva Investigational Site 12074

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Teva Investigational Site 12086

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Teva Investigational Site 12092

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Teva Investigational Site 12076

    North Miami Beach, Florida 33169
    United States

    Active - Recruiting

  • Teva Investigational Site 12095

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • Teva Investigational Site 12075

    Pompano Beach, Florida 33064
    United States

    Active - Recruiting

  • Teva Investigational Site 12078

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Teva Investigational Site 12073

    Minneapolis, Minnesota 55402
    United States

    Active - Recruiting

  • Teva Investigational Site 12066

    Richfield, Minnesota 55423
    United States

    Active - Recruiting

  • Teva Investigational Site 12085

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Teva Investigational Site 12063

    Toledo, Ohio 43617
    United States

    Active - Recruiting

  • Teva Investigational Site 12072

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Teva Investigational Site 12067

    Columbia, South Carolina 29204
    United States

    Active - Recruiting

  • Teva Investigational Site 12112

    North Charleston, South Carolina 29420
    United States

    Active - Recruiting

  • Teva Investigational Site 12060

    Austin, Texas 78759
    United States

    Active - Recruiting

  • Teva Investigational Site 12083

    Austin, Texas 78744
    United States

    Active - Recruiting

  • Teva Investigational Site 12077

    Corsicana, Texas 75110-2471
    United States

    Active - Recruiting

  • Teva Investigational Site 12090

    Dallas, Texas 75203
    United States

    Active - Recruiting

  • Teva Investigational Site 12143

    El Paso, Texas 79925
    United States

    Active - Recruiting

  • Teva Investigational Site 12082

    Salt Lake City, Utah 84123
    United States

    Active - Recruiting

  • Teva Investigational Site 12093

    Portsmouth, Virginia 23703
    United States

    Active - Recruiting

  • Teva Investigational Site 12062

    Greenfield, Wisconsin 53228
    United States

    Active - Recruiting

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