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Clinical Trials in the USA / NCT06052267
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
Sponsor
Teva Branded Pharmaceutical Products R&D LLC
Phase
Phase 3
Started
2023-08-30
Last updated
2026-09-11

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)

Trial sites (393)

FacilityCityRegionStatus
Teva Investigational Site 15706 Birmingham Alabama
Teva Investigational Site 15786 Birmingham Alabama
Teva Investigational Site 15768 Dothan Alabama
Teva Investigational Site 15581 Paradise Valley Arizona
Teva Investigational Site 15710 Scottsdale Arizona
Teva Investigational Site 15661 Tucson Arizona
Teva Investigational Site 15685 Bakersfield California
Teva Investigational Site 15721 Fresno California
Teva Investigational Site 15788 Huntington Beach California
Teva Investigational Site 15720 La Jolla California
Teva Investigational Site 15687 La Palma California
Teva Investigational Site 15708 Long Beach California
Teva Investigational Site 15712 Long Beach California
Teva Investigational Site 15643 Los Angeles California
Teva Investigational Site 15695 Napa California
Teva Investigational Site 15692 Northridge California
Teva Investigational Site 15682 Redondo Beach California
Teva Investigational Site 15629 San Bernardino California
Teva Investigational Site 15709 San Diego California
Teva Investigational Site 15704 San Jose California
Teva Investigational Site 15620 Stockton California
Teva Investigational Site 15621 Westminster California
Teva Investigational Site 15612 Aurora Colorado
Teva Investigational Site 15588 Colorado Springs Colorado
Teva Investigational Site 15765 Colorado Springs Colorado
Teva Investigational Site 15676 Englewood Colorado
Teva Investigational Site 15781 Washington D.C. District of Columbia
Teva Investigational Site 15660 Aventura Florida
Teva Investigational Site 15624 Cape Coral Florida
Teva Investigational Site 15598 Cutler Bay Florida
Teva Investigational Site 15776 Doral Florida
Teva Investigational Site 15579 Greenacres City Florida
Teva Investigational Site 15582 Hialeah Florida
Teva Investigational Site 15664 Hialeah Florida
Teva Investigational Site 15657 Homestead Florida
Teva Investigational Site 15713 Jacksonville Florida
Teva Investigational Site 15632 Leesburg Florida
Teva Investigational Site 15777 Margate Florida
Teva Investigational Site 15602 Miami Florida
Teva Investigational Site 15722 Miami Florida

+ 353 more sites — see the full list on the official registry below.

More Teva Branded Pharmaceutical Products R&D LLC trials in the USA

Other trials for the same condition

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