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ACTIVE NOT RECRUITING

NCT06372496

PHASE4

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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

Official title: A Phase 4, 52-week (Primary Analysis at 24-weeks), Randomized, Stratified, Open-label, Active-controlled, Parallel-group, Effectiveness Study, Comparing FF/UMEC/VI With Non-ellipta Usual Care (ICS/LABA) in Adult Participants With Uncontrolled Asthma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1366

Start Date

2024-04-16

Completion Date

2027-03-31

Last Updated

2026-03-24

Healthy Volunteers

Conditions

Asthma

Interventions

DRUG

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate

Participants will receive FF/UMEC/VI

DRUG

Inhaled corticosteroids/long-acting beta-2 agonists

Participants will receive ICS/LABA

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)

GSK Investigational Site

Centreville, Alabama, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Newport Beach, California, United States

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Newark, Delaware, United States

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Clearwater, Florida, United States

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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

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Palm Springs, Florida, United States

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Port Charlotte, Florida, United States

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Tallahassee, Florida, United States

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Normal, Illinois, United States

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New Orleans, Louisiana, United States

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Bangor, Maine, United States

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Detroit, Michigan, United States

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Warren, Michigan, United States

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Missoula, Montana, United States

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Papillion, Nebraska, United States

GSK Investigational Site

Brick, New Jersey, United States

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Linwood, New Jersey, United States

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New Windsor, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Rock Hill, South Carolina, United States

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Spartanburg, South Carolina, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Bellingham, Washington, United States

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Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

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Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Concepción del Uruguay, Argentina

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Córdoba, Argentina

GSK Investigational Site

Formosa, Argentina

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Luján, Argentina

GSK Investigational Site

Luján de Cuyo, Argentina

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Mar del Plata, Argentina

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Mendoza, Argentina

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Mendoza, Argentina

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Mendoza, Argentina

GSK Investigational Site

Quilmes, Argentina

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Rosario, Argentina

GSK Investigational Site

Rosario, Argentina

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Rosario, Argentina

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San Juan Bautista, Argentina

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San Miguel de Tucumán, Argentina

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Santa Fe, Argentina

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Bruce, Australian Capital Territory, Australia

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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

Chancheng District, Foshan City, China

GSK Investigational Site

Liwan District, Guangzhou, China

GSK Investigational Site

North Street, Jiangmen City, China

GSK Investigational Site

Nanshan District, China

GSK Investigational Site

Zhuhai, China

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Gifu, Japan

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Hiroshima, 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

Miyagi, Japan

GSK Investigational Site

Miyazaki, Japan

GSK Investigational Site

Miyazaki, Japan

GSK Investigational Site

Nagaoka-Shi, Japan

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Niigata, Japan

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Okawa-shi, Japan

GSK Investigational Site

Ōita, Japan

GSK Investigational Site

Shinjuku-kuTokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

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Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

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Tokyo, Japan

GSK Investigational Site

Yokohama, Japan

GSK Investigational Site

Busan, South Korea

GSK Investigational Site

Daegu, South Korea

GSK Investigational Site

Seongnam-si Gyeonggi-do, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Suwon Kyunggi-do, South Korea

GSK Investigational Site

Kaohsiung City, Taiwan

GSK Investigational Site

Taichung, Taiwan

GSK Investigational Site

Taichung, Taiwan

GSK Investigational Site

Taipei, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (117)