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

Teva Branded Pharmaceutical Products R&D LLC
NCT IDNCT06052267ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

2,196

Study length

about 2.9 years

Ages

4+

Locations

157 sites in AL, AZ, CA +30

What this study is about

Researchers are testing whether a fixed dose combination of fluticasone propionate and albuterol sulfate, given as an inhaler, can help prevent severe asthma attacks. The trial will last for up to 35 months and involve adults and children with asthma.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Albuterol sulfate
  • 2.Take TEV-56248

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
inhaled

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

Respiratory System Agent (Adrenergic beta2-Agonists)

Drug routes

inhaled

Endpoints

Secondary: Composite Responders Based on Asthma Quality of Life Questionnaire + 12 (AQLQ+12) or Pediatric AQLQ (PAQLQ), Number of Participants Who Withdrew From the Trial Due to Treatment-Emergent Adverse Events, Number of Participants with at Least One Adverse Event, Number of Participants with at Least One Serious Adverse Event

Body systems

Respiratory