Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 9 changes
notable Trial sites expanded: 178 -> 183 locations 2026-06-26
notable Trial sites expanded: 175 -> 178 locations 2026-06-18
notable Primary completion pushed: 2026-05-31 -> 2026-09-19 2026-06-02
minor Completion pushed: 2026-05-31 -> 2026-09-19 2026-06-02
notable Trial sites expanded: 163 -> 175 locations 2026-05-23
notable Trial sites expanded: 156 -> 163 locations 2026-05-13
notable Trial sites expanded: 149 -> 156 locations 2026-05-05
notable Sponsor changed: Teva Branded Pharmaceutical Products R&D, Inc. -> Teva Branded Pharmaceutical Products R&D LLC 2026-04-22
notable Trial sites expanded: 140 -> 149 locations 2026-04-22
Trial Details
NCT Number NCT06664619
Lead Sponsor Teva Branded Pharmaceutical Products R&D LLC
Conditions Asthma
Enrollment 724 participants
Start Date 2024-12-12
Primary Completion 2026-09-19 (estimated)
Study Completion 2026-09-19 (estimated)
Updated on ClinicalTrials.gov 2026-06-25