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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

Active Not RecruitingPhase 4

Sponsor: GlaxoSmithKline

Conditions: Asthma

Interventions: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate, Inhaled corticosteroids/long-acting beta-2 agonists

Countries: United States, Argentina, Australia, Canada, China, Japan, South Korea, Taiwan

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (117)

Centreville, Alabama, United States
Little Rock, Arkansas, United States
Newport Beach, California, United States
Newark, Delaware, United States
Clearwater, Florida, United States
Florida City, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Palm Springs, Florida, United States
Port Charlotte, Florida, United States
Tallahassee, Florida, United States
Normal, Illinois, United States
New Orleans, Louisiana, United States
Bangor, Maine, United States
Detroit, Michigan, United States
Warren, Michigan, United States
Missoula, Montana, United States
Papillion, Nebraska, United States
Brick, New Jersey, United States
Linwood, New Jersey, United States
New Windsor, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
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