Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
NCT ID: NCT06372496
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
1357 participants
INTERVENTIONAL
2024-04-16
2026-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI)
Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
Participants will receive FF/UMEC/VI
Inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA)
Inhaled corticosteroids/long-acting beta-2 agonists
Participants will receive ICS/LABA
Interventions
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Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
Participants will receive FF/UMEC/VI
Inhaled corticosteroids/long-acting beta-2 agonists
Participants will receive ICS/LABA
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Newport Beach, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
North Miami Beach, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Palm Springs, Florida, United States
GSK Investigational Site
Port Charlotte, Florida, United States
GSK Investigational Site
Tallahassee, Florida, United States
GSK Investigational Site
Normal, Illinois, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Bangor, Maine, United States
GSK Investigational Site
Warren, Michigan, United States
GSK Investigational Site
Missoula, Montana, United States
GSK Investigational Site
Papillion, Nebraska, United States
GSK Investigational Site
Linwood, New Jersey, United States
GSK Investigational Site
New Windsor, New York, United States
GSK Investigational Site
Asheville, North Carolina, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Rock Hill, South Carolina, United States
GSK Investigational Site
Spartanburg, South Carolina, United States
GSK Investigational Site
Beaumont, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Concepción del Uruguay, , Argentina
GSK Investigational Site
Mendoza, , Argentina
GSK Investigational Site
Quilmes, , Argentina
GSK Investigational Site
Rosario, , Argentina
GSK Investigational Site
Rosario, , Argentina
GSK Investigational Site
Bruce, Australian Capital Territory, Australia
GSK Investigational Site
Blacktown, New South Wales, Australia
GSK Investigational Site
Coffs Harbour, New South Wales, Australia
GSK Investigational Site
Kanwal, New South Wales, Australia
GSK Investigational Site
Sydney, New South Wales, Australia
GSK Investigational Site
Brisbane, Queensland, Australia
GSK Investigational Site
Osborne Park, Western Australia, Australia
GSK Investigational Site
Spearwood, Western Australia, Australia
GSK Investigational Site
Windsor, Ontario, Canada
GSK Investigational Site
Trois-Rivières, Quebec, Canada
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Gifu, , Japan
GSK Investigational Site
Hiroshima, , Japan
GSK Investigational Site
Hyōgo, , Japan
GSK Investigational Site
Kagawa, , Japan
GSK Investigational Site
Kagoshima, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Kumamoto, , Japan
GSK Investigational Site
Kumamoto, , Japan
GSK Investigational Site
Matsuyama, , Japan
GSK Investigational Site
Miyazaki, , Japan
GSK Investigational Site
Miyazaki, , Japan
GSK Investigational Site
Nagaoka-Shi, , Japan
GSK Investigational Site
Niigata, , Japan
GSK Investigational Site
Okawa-shi, , Japan
GSK Investigational Site
Ōita, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Yokohama, , Japan
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Kaohsiung City, , Taiwan
GSK Investigational Site
Taichung, , Taiwan
Countries
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Other Identifiers
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219912
Identifier Type: -
Identifier Source: org_study_id
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