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

Running, not enrolling · Phase 4

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT06372496

Run by

GlaxoSmithKline

People needed

1366

Starts

2024-04-16

Expected to finish

2027-03-31

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023 guidelines for at least 3 months prior to randomization.
• Participants who are either:
• Currently untreated
• Treated with daily maintenance ICS or ICS/LABA
• ACQ-6 score ≥1.5 at randomization.
• 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)
• Participants must be able to complete the study questionnaires.

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Recent history of life-threatening asthma
• History of >1 severe exacerbation of asthma within 12 months prior to randomization.
• 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.
• A WOCBP must have a negative pregnancy test ≤7 days prior to randomization.
• 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.
• Ongoing need for biologic therapy or recent use of a biologic therapy
• Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
• Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study.
• Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing
• Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization.
• Participants with a history of hypersensitivity to any of the study medications

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Newark, Delaware, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Florida City, Florida, 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 — Miami, Florida, United States
• GSK Investigational Site — North Miami Beach, 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 — Detroit, Michigan, 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 — Brick, New Jersey, 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 — Centreville, Alabama, United States

Full record on ClinicalTrials.gov

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