Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
Condition(s) studied
Investigational drug(s) / intervention(s)
Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate: Participants will receive FF/UMEC/VI
Inhaled corticosteroids/long-acting beta-2 agonists: Participants will receive ICS/LABA
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
Eligibility
Primary outcome measure(s)
- Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24 — Baseline (Day 1) and at Week 24
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value
Trial sites (117)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Centreville | Alabama | |
| GSK Investigational Site | Little Rock | Arkansas | |
| GSK Investigational Site | Newport Beach | California | |
| GSK Investigational Site | Newark | Delaware | |
| GSK Investigational Site | Clearwater | Florida | |
| GSK Investigational Site | Miami | Florida | |
| GSK Investigational Site | Miami | Florida | |
| GSK Investigational Site | Miami | Florida | |
| GSK Investigational Site | North Miami Beach | Florida | |
| GSK Investigational Site | Orlando | Florida | |
| GSK Investigational Site | Palm Springs | Florida | |
| GSK Investigational Site | Port Charlotte | Florida | |
| GSK Investigational Site | Tallahassee | Florida | |
| GSK Investigational Site | Normal | Illinois | |
| GSK Investigational Site | New Orleans | Louisiana | |
| GSK Investigational Site | Bangor | Maine | |
| GSK Investigational Site | Detroit | Michigan | |
| GSK Investigational Site | Warren | Michigan | |
| GSK Investigational Site | Missoula | Montana | |
| GSK Investigational Site | Papillion | Nebraska | |
| GSK Investigational Site | Brick | New Jersey | |
| GSK Investigational Site | Linwood | New Jersey | |
| GSK Investigational Site | New Windsor | New York | |
| GSK Investigational Site | Asheville | North Carolina | |
| GSK Investigational Site | Charlotte | North Carolina | |
| GSK Investigational Site | Greenville | North Carolina | |
| GSK Investigational Site | Winston-Salem | North Carolina | |
| GSK Investigational Site | Cincinnati | Ohio | |
| GSK Investigational Site | DuBois | Pennsylvania | |
| GSK Investigational Site | Philadelphia | Pennsylvania | |
| GSK Investigational Site | Pittsburgh | Pennsylvania | |
| GSK Investigational Site | Rock Hill | South Carolina | |
| GSK Investigational Site | Spartanburg | South Carolina | |
| GSK Investigational Site | Beaumont | Texas | |
| GSK Investigational Site | Dallas | Texas | |
| GSK Investigational Site | Bellingham | Washington | |
| GSK Investigational Site | Buenos Aires | Argentina | |
| GSK Investigational Site | Buenos Aires | Argentina | |
| GSK Investigational Site | Buenos Aires | Argentina | |
| GSK Investigational Site | Buenos Aires | Argentina |
+ 77 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06372496 on ClinicalTrials.gov ↗ ← All trials in Australia