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.
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Child, Adult, Older Adult
- Age Range
- 12 Years and older
- Trial Duration
- December 12, 2024 - May 31, 2026
- Phase
- Phase 3
