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Active, not recruiting Phase 3

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

NCT06052267 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2023-08-30
Last updated
2026-11-04

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

TEV-56248Albuterol sulfate →

TEV-56248: Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.

Albuterol sulfate: Oral inhalation powder

Study 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

Eligibility

Sex
ALL
Min age
4 Years
Max age
—
Healthy volunteers
No
Inclusion 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 NOTE- Additional criteria apply, please contact the investigator for more information. Exclusion Criteria: * 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. NOTE- Additional criteria apply, please contact the investigator for more information

Primary outcome measure(s)

  • Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI — Up to 42 months

Trial sites (391)

FacilityCityRegionStatus
AllerVie Clnical Research Birmingham Alabama
The University of Alabama at Birmingham Birmingham Alabama
SEC Clinical Research Dothan Alabama
One of a Kind Clinical Research Center LLC Paradise Valley Arizona
Mayo Clinic Scottsdale Arizona
Novak Clinical Research Tucson Arizona
Kern Research, Inc Bakersfield California
Clinical Research of Central California, LLC Fresno California
Allergy and Asthma Specialists Medical Group Huntington Beach California
Orso Health La Jolla California
IMAX Clinical Trials La Palma California
Long Beach Clinical Trials Long Beach California
Ark Clinical Research, LLC Long Beach California
Ricardo Antonio Tan Inc Los Angeles California
One of a Kind Clinical Research Center LLC Napa California
California Medical Research Associates Inc. Northridge California
Riviera Allergy Medical Center Redondo Beach California
Velocity Clinical Research, Banning San Bernardino California
Institute of HealthCare Assessment, Inc San Diego California
Allergy and Asthma Associates San Jose California
Bensch Clinical Research LLC Stockton California
Allianz Research Institute Westminster California
Allianz Research Institute Aurora Colorado
CRN Clinical Research Network LLC/Asthma and Allergy Associates P.C. Colorado Springs Colorado
OptumCare Colorado Springs LLC Colorado Springs Colorado
Velocity Clinical Research Englewood Colorado
Emerson Clinical Research Institute Washington D.C. District of Columbia
Florida Center for Allergy and Asthma Research Aventura Florida
Renaissance Research and Medical Group Cape Coral Florida
Cenara Clinical Research Cutler Bay Florida
D & H Doral Research Centers Doral Florida
Finlay Medical Research Corp Greenacres City Florida
Direct Helpers Research Center, Inc. Hialeah Florida
New Life Research Institute, LLC Hialeah Florida
Homestead Medical Research Homestead Florida
Nemours Children Clinic Jacksonville Florida
Clinical Site Partner, LLC DBA Flourish Research Leesburg Florida
D & H Pompano Research Centers, Inc. Margate Florida
EMDA Clinical Research Miami Florida
Finlay Medical Research Miami Florida

+ 351 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06052267 on ClinicalTrials.gov ↗ ← All trials in the USA