Efficacy and Safety of Fluticasone Propionate/​Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma

Study Title
A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Fluticasone Propionate/Albuterol Sulfate Combination Compared to Fluticasone Propionate, Albuterol Sulfate or Placebo Delivered by Multidose Dry Powder Inhaler in Participants 12 Years and Older With Asthma
Teva Identifier
FpA-AS-30093
ClinicalTrials.gov Identifier
NCT06664619
Study Status
Recruiting
Trial Condition(s)
Asthma
Interventions
Drug: Fp/ABS, FP, ABS, Placebo

Study Description

Primary objectives:
The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI).

Secondary objective:
- To evaluate the efficacy of Fp/ABS eMDPI administered four times daily
- To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks
- To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose
- The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.

Print

Participation criteria and map of study locations


Key Participation Requirements

Gender
Female, Male
Age Range
12 Years and older
Trial Duration
December 12, 2024 - May 31, 2026
Phase
Phase 3

Study Type

Interventional