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Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
NCT06372496 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
- DRUG Inhaled corticosteroids/long-acting beta-2 agonists
Study Locations (20)
Florida
- GSK Investigational Site — Miami
- GSK Investigational Site — Miami
- GSK Investigational Site — Miami
- GSK Investigational Site — North Miami Beach
- GSK Investigational Site — Orlando
- GSK Investigational Site — Palm Springs
- GSK Investigational Site — Port Charlotte
- GSK Investigational Site — Tallahassee
North Carolina
- GSK Investigational Site — Asheville
- GSK Investigational Site — Charlotte
Arkansas
- GSK Investigational Site — Little Rock
California
- GSK Investigational Site — Newport Beach
Illinois
- GSK Investigational Site — Normal
Louisiana
- GSK Investigational Site — New Orleans
Maine
- GSK Investigational Site — Bangor
Michigan
- GSK Investigational Site — Warren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,357 participants |
| Start Date | 2024-04-16 |
| Est. Completion | 2026-01-22 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06372496
The ClinicalTrials.gov registry entry for NCT06372496 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,357 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions — of which Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06372496 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, North Carolina, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06372496 about?
NCT06372496 is a clinical study titled "Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma". 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
What is the current status of trial NCT06372496?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 1,357 participants. The study started on 2024-04-16. Estimated completion is 2026-01-22.
What conditions does trial NCT06372496 study?
This clinical trial studies the following conditions: Asthma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06372496?
The interventions under investigation include: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (DRUG), Inhaled corticosteroids/long-acting beta-2 agonists (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06372496?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06372496 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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