NCT06372496

Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma

A Phase 4, 52-week (Primary Analysis at 24-weeks), Randomized, Stratified, Open-label, Active-controlled, Parallel-group, Effectiveness Study, Comparing FF/UMEC/VI With Non-ellipta Usual Care (ICS/LABA) in Adult Participants With Uncontrolled Asthma

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,366 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate	Participants will receive FF/UMEC/VI
DRUG	Inhaled corticosteroids/long-acting beta-2 agonists	Participants will receive ICS/LABA

Timeline

• Start date: 2024-04-16
• Primary completion: 2025-07-28
• Completion: 2027-03-31
• First posted: 2024-04-18
• Last updated: 2026-03-24

Locations

117 sites across 8 countries: United States, Argentina, Australia, Canada, China, Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study