Study ID: FpA-AS-30094

Study Title

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

Teva Identifier

FpA-AS-30094 Identifier


Study Status


Trial Condition(s)



Drug: TEV-56248 | Drug: Albuterol sulfate

Study Description

The primary objective of the study is to demonstrate the efficacy of high dose and low 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 are to evaluate the efficacy of Fp/ABS compared to ABS and the effect on systemic corticosteroid (SCS) exposure, and to evaluate the safety and tolerability of Fp/ABS. 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 35 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria.

Key Participation Requirements


Female, Male

Age Range

4 years and older

Trial Duration

August 30, 2023 - July 17, 2026


Phase 3

Study Type