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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023 guidelines for at least 3 months prior to randomization.
2. Participants who are either:
* Currently untreated
* Treated with daily maintenance ICS or ICS/LABA
3. ACQ-6 score ≥1.5 at randomization.
4. Participants able to perform technically acceptable and repeatable FEV1 maneuvers (i.e., a minimum of 2 acceptable and 1 repeatable effort) at visit 2 (V2)
5. Participants must be able to complete the study questionnaires.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
1. Recent history of life-threatening asthma
2. History of \>1 severe exacerbation of asthma within 12 months prior to randomization.
3. Women of childbearing potential that are not following at least one highly effective method of contraception. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study.
4. A WOCBP must have a negative pregnancy test ≤7 days prior to randomization.
5. Exposure to inhaler triple therapy \[ICS + Long-acting muscarinic antagonist (LAMA) + LABA as Single inhaler triple therapy (SITT) or Multiple inhaler triple therapy(MITT)\] and/or any LAMA-containing therapy within 12 months prior to randomization.
6. Ongoing need for biologic therapy or recent use of a biologic therapy
7. Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study.
9. Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing
10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization.
11. Participants with a history of hypersensitivity to any of the study medications
Primary outcome measure(s)
Change from baseline in trough forced expiratory volume in 1 second (FEV1) — Baseline (Day 1), and at Week 24
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
Florida City
Florida
GSK Investigational Site
Miami
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
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
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.
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.
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