Fixed-Dose Fluticasone Propionate/Albuterol Sulfate in Preventing Asthma Exacerbations

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
ClinicalTrials.gov Identifier
NCT06052267
Study Status
Recruiting
Trial Condition(s)
Asthma
Interventions
Drug: TEV-56248 | Drug: Albuterol sulfate
EU CT Number
2023-505435-12-00

Study Description

Primary objectives:
The primary objective of the study is to assess 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:
- To evaluate the efficacy of Fp/ABS 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 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

Gender
Female, Male
Age group
Child
Age Range
4 years and older
Trial Duration
August 30, 2023 - July 17, 2026
Phase
Phase 3

Study Type

Interventional