NCT06372496Not yet recruiting

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

Name: Clinical Trial NCT06372496
Creator: GlaxoSmithKline
Keywords: Asthma, Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate, Phase 4, drug, clinical trial, Argentina,Australia,Canada,Japan,South Korea,Taiwan,United States of America

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

GlaxoSmithKlinePhase 4ClinicalTrials.govdrug

Verified

Study focus

Disease/Condition: Asthma
Drug/Device/Intervention: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: GlaxoSmithKline
Location: Little Rock,Newport Beach,Miami,Miami,Miami,Orlando,Port Charlotte,Tallahassee,Columbus,Normal,Bangor,Columbia,Brick,Linwood,New Windsor,Asheville,Charlotte,Greenville,Raleigh,Winston-Salem,Cincinnati, Argentina,Australia,Canada,Japan,South Korea,Taiwan,United States of America

Timeline & enrollment

Phase: Phase 4
Start date: Apr 16, 2024
End date: Mar 11, 2026
Enrollment: 1136 participants

Primary outcome

Change from baseline in trough forced expiratory volume in 1 second (FEV1)

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

ICD-10 classifications

AsthmaAsthma, unspecifiedNonallergic asthmaMixed asthmaPredominantly allergic asthma

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06372496
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06372496 through Pure Global AI's free database. This Phase 4 trial is sponsored by GlaxoSmithKline and is currently Not yet recruiting. The study focuses on Asthma. Target enrollment is 1136 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.