A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

Description

The primary objective of the study is to assess the efficacy of high dose and low 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 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 35 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria.

Conditions

Asthma

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Study Overview

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Study Details

Study overview

The primary objective of the study is to assess the efficacy of high dose and low 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 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 35 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria.

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

A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

Condition
Asthma
Intervention / Treatment

-

Contacts and Locations

Dothan

Teva Investigational Site 15768, Dothan, Alabama, United States, 36305

Paradise Valley

Teva Investigational Site 15581, Paradise Valley, Arizona, United States, 85258

Tucson

Teva Investigational Site 15661, Tucson, Arizona, United States, 85741

Bakersfield

Teva Investigational Site 15685, Bakersfield, California, United States, 93301

Fresno

Teva Investigational Site 15721, Fresno, California, United States, 93720

Huntington Beach

Teva Investigational Site 15788, Huntington Beach, California, United States, 92647-6853

La Jolla

Teva Investigational Site 15720, La Jolla, California, United States, 92037

La Palma

Teva Investigational Site 15687, La Palma, California, United States, 90623

Long Beach

Teva Investigational Site 15708, Long Beach, California, United States, 90806-2613

Long Beach

Teva Investigational Site 15712, Long Beach, California, United States, 90815

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * The participant has a documented diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines.
  • * The participant has a documented history of at least 1 severe clinical asthma exacerbation (CAE) ending within the past 12 month.
  • * The participant is using any prescribed inhaled asthma controller medication (at a stable dose for 1 month prior to the screening visit).
  • * If female, the 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 study), or is of nonchildbearing potential
  • * The participant has life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years before screening.
  • * The participant has a suspected bacterial or viral infection (other than Coronavirus Disease \[COVID-19\]) of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period.
  • * Participants with a confirmed infection with COVID-19 within 6 weeks prior to the screening visit, or with residual COVID-19 symptoms ("long COVID-19").
  • * The participant has had a clinical asthma exacerbation (CAE) requiring systemic corticosteroids within 30 days before screening, or any hospitalization for asthma within 2 months before 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.
  • * The participant has significantly abused alcohol and/or illicit prohibited drugs within the previous 24 months.
  • * The participant has participated as a randomized participant in any investigational drug study within 30 days.
  • * The participant has been hospitalized for psychiatric disorder or attempted suicide within 1 year of screening.

Ages Eligible for Study

4 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Teva Branded Pharmaceutical Products R&D, Inc.,

Teva Medical Expert, MD, STUDY_DIRECTOR, Teva Branded Pharmaceutical Products R&D, Inc.

Study Record Dates

2026-07-17