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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

TEV-56248

Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.

DRUG

Albuterol sulfate

Oral inhalation powder

Locations (20)

Teva Investigational Site 15706
Birmingham, Alabama, United States
Teva Investigational Site 15786
Birmingham, Alabama, United States
Teva Investigational Site 15768
Dothan, Alabama, United States
Teva Investigational Site 15581
Paradise Valley, Arizona, United States
Teva Investigational Site 15710
Scottsdale, Arizona, United States
Teva Investigational Site 15661
Tucson, Arizona, United States
Teva Investigational Site 15685
Bakersfield, California, United States
Teva Investigational Site 15721
Fresno, California, United States
Teva Investigational Site 15788
Huntington Beach, California, United States
Teva Investigational Site 15720
La Jolla, California, United States
Teva Investigational Site 15687
La Palma, California, United States
Teva Investigational Site 15708
Long Beach, California, United States
Teva Investigational Site 15712
Long Beach, California, United States
Teva Investigational Site 15643
Los Angeles, California, United States
Teva Investigational Site 15695
Napa, California, United States
Teva Investigational Site 15692
Northridge, California, United States
Teva Investigational Site 15682
Redondo Beach, California, United States
Teva Investigational Site 15629
San Bernardino, California, United States
Teva Investigational Site 15709
San Diego, California, United States
Teva Investigational Site 15704
San Jose, California, United States