NCT06052267

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,700 (estimated)
• Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	TEV-56248	Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
DRUG	Albuterol sulfate	Oral inhalation powder

Timeline

• Start date: 2023-08-30
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2023-09-25
• Last updated: 2026-04-09

Locations

393 sites across 22 countries: United States, Argentina, Australia, Bulgaria, Canada, Czechia, Denmark, Germany, Greece, Hungary, Israel, Italy, Latvia, Mexico, New Zealand, Poland, Romania, Serbia, Slovakia, South Africa, South Korea, Spain

Regulatory

• FDA-regulated drug study