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

Running, not enrolling · Phase 3

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT06052267

Run by

Teva Branded Pharmaceutical Products R&D LLC

People needed

2772

Starts

2023-08-30

Expected to finish

2026-10-31

Last updated by the study team

2026-07-24

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Teva Investigational Site 32847 — München, Germany
• Teva Investigational Site 32828 — München, Germany
• Teva Investigational Site 32843 — Neu-Isenburg, Germany
• Teva Investigational Site 32839 — Neuss, Germany
• Teva Investigational Site 32836 — Peine, Germany
• 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 32832 — Mainz, Germany

Full record on ClinicalTrials.gov

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