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Testing a new inhaler to prevent asthma attacks

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

Phase 3 Interventional Teva Branded Pharmaceutical Products R&D, Inc. · NCT06052267

This study is testing a new inhaler that combines two asthma medications to see if it can better prevent severe asthma attacks compared to using just one of the medications alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2700 (estimated)
Ages4 Years and up
SexAll
SponsorTeva Branded Pharmaceutical Products R&D, Inc. Industry-sponsored
Locations393 sites (Birmingham, Alabama and 392 other locations)
Trial IDNCT06052267 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a fixed-dose combination of fluticasone propionate and albuterol sulfate delivered via an electronic multidose dry powder inhaler in reducing severe asthma exacerbations compared to albuterol alone. Participants will undergo a minimum of 28 weeks of treatment, including a screening phase and a double-blind treatment period. The study will also assess the safety and tolerability of the combination therapy and its impact on the need for systemic corticosteroids.

Who should consider this trial

Good fit: Ideal candidates are individuals with a documented diagnosis of asthma for at least one year and a history of severe asthma exacerbations in the past year.

Not a fit: Patients with life-threatening asthma or those who have experienced significant asthma episodes requiring intubation in the past five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of severe asthma attacks for patients.

How similar studies have performed: Previous studies have shown promising results with similar combination therapies for asthma management, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 392 other locations

+343 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Asthma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.