NCT06664619

A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 724 (estimated)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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 objectives are: * 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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fp/ABS	Inhalation powder
DRUG	FP	Inhalation powder
DRUG	ABS	Inhalation powder
DRUG	Placebo	Inhalation powder

Timeline

• Start date: 2024-12-12
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2024-10-29
• Last updated: 2026-04-02

Locations

140 sites across 11 countries: United States, Argentina, Bulgaria, Czechia, Germany, Israel, Mexico, Poland, Romania, Slovakia, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study