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

Last updated: March 14, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Not Recruiting

Phase

4

Condition

Asthma

Treatment

Inhaled corticosteroids/long-acting beta-2 agonists

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate

Clinical Study ID

NCT06372496
219912
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

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) 2022guidelines for at least 3 months prior to randomization.

  2. Participants who are either:

  • Currently untreated

  • Treated with daily maintenance ICS or ICS/LABA

  1. ACQ-6 score ≥1.5 at randomization.

  2. Participants must be able to complete the study questionnaires.

Exclusion

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 effectivemethod of contraception. This includes women who are pregnant or lactating or areplanning 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 tripletherapy(MITT)] and/or any LAMA-containing therapy within 12 months prior torandomization.

  6. Ongoing need for biologic therapy or recent use of a biologic therapy

  7. Participants with the diagnosis of chronic obstructive pulmonary disease, as perGlobal Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.

  8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTAare not eligible to enter the study.

  9. Participants who are medically unable to withhold their albuterol/salbutamol for 6hours prior to spirometry testing

  10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior torandomization.

  11. Participants with a history of hypersensitivity to any of the study medications

Study Design

Total Participants: 1358
Treatment Group(s): 2
Primary Treatment: Inhaled corticosteroids/long-acting beta-2 agonists
Phase: 4
Study Start date:
April 16, 2024
Estimated Completion Date:
March 11, 2026

Connect with a study center

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1192AAW
    Argentina

    Site Not Available

  • GSK Investigational Site

    Florencio Varela, Buenos Aires 1888
    Argentina

    Site Not Available

  • GSK Investigational Site

    Florencio Varela, Buenos Aires 1888
    Argentina

    Site Not Available

  • GSK Investigational Site

    Mar del Plata, Buenos Aires 7600
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cordoba, Córdova X5003DCE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, C1425BEN
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aires, C1192AAW
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, FVH1425
    Argentina

    Site Not Available

  • GSK Investigational Site

    Concepcion del Uruguay, 3260
    Argentina

    Site Not Available

  • GSK Investigational Site

    Mendoza, 5577
    Argentina

    Site Not Available

  • GSK Investigational Site

    Quilmes, 1878
    Argentina

    Site Not Available

  • GSK Investigational Site

    Rosario, S2000DBS
    Argentina

    Site Not Available

  • GSK Investigational Site

    Bruce, Australian Capital Territory 2617
    Australia

    Site Not Available

  • GSK Investigational Site

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • GSK Investigational Site

    Campbelltown, New South Wales 2560
    Australia

    Site Not Available

  • GSK Investigational Site

    Coffs Harbour, New South Wales 2450
    Australia

    Site Not Available

  • GSK Investigational Site

    Kanwal, New South Wales 2259
    Australia

    Site Not Available

  • GSK Investigational Site

    Sydney, New South Wales 2035
    Australia

    Site Not Available

  • GSK Investigational Site

    Brisbane, Queensland 4006
    Australia

    Site Not Available

  • GSK Investigational Site

    Murdoch, Western Australia 6163
    Australia

    Site Not Available

  • GSK Investigational Site

    Osborne Park, Western Australia 6017
    Australia

    Site Not Available

  • GSK Investigational Site

    Spearwood, Western Australia 6163
    Australia

    Site Not Available

  • GSK Investigational Site

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • GSK Investigational Site

    Windsor, Ontario N8X 1T3
    Canada

    Site Not Available

  • GSK Investigational Site

    Trois RiviEres, Quebec G9A 4P3
    Canada

    Site Not Available

  • GSK Investigational Site

    Trois-Rivieres, Quebec G9A 4P3
    Canada

    Site Not Available

  • GSK Investigational Site

    Saskatoon, Saskatchewan S7N OW8
    Canada

    Site Not Available

  • GSK Investigational Site

    Fukuoka, 820-8505
    Japan

    Site Not Available

  • GSK Investigational Site

    Gifu, 509-6134
    Japan

    Site Not Available

  • GSK Investigational Site

    Hiroshima, 730-0853
    Japan

    Site Not Available

  • GSK Investigational Site

    Hyogo, 651-0053
    Japan

    Site Not Available

  • GSK Investigational Site

    Kagawa, 761-8073
    Japan

    Site Not Available

  • GSK Investigational Site

    Kagoshima, 890-0053
    Japan

    Site Not Available

  • GSK Investigational Site

    Kanagawa, 252-0143
    Japan

    Site Not Available

  • GSK Investigational Site

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • GSK Investigational Site

    Kumamoto-shi, 862-0965
    Japan

    Site Not Available

  • GSK Investigational Site

    Matsuyama-shi, 790-0925
    Japan

    Site Not Available

  • GSK Investigational Site

    Miyazaki, 880-2112
    Japan

    Site Not Available

  • GSK Investigational Site

    Nagaoka-Shi, 940-0087
    Japan

    Site Not Available

  • GSK Investigational Site

    Niigata, 950-0088
    Japan

    Site Not Available

  • GSK Investigational Site

    Oita,
    Japan

    Site Not Available

  • GSK Investigational Site

    Okawa-shi, 831-0016
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo, 157-0066
    Japan

    Site Not Available

  • GSK Investigational Site

    Yokohama-shi, 223-0053
    Japan

    Site Not Available

  • GSK Investigational Site

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taichung, 40447
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • GSK Investigational Site

    Newport Beach, California 92663
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33173
    United States

    Site Not Available

  • GSK Investigational Site

    North Miami Beach, Florida 33169
    United States

    Site Not Available

  • GSK Investigational Site

    Orlando, Florida 32819
    United States

    Site Not Available

  • GSK Investigational Site

    Palm Springs, Florida 33406
    United States

    Site Not Available

  • GSK Investigational Site

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • GSK Investigational Site

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • GSK Investigational Site

    Columbus, Georgia 31904
    United States

    Site Not Available

  • GSK Investigational Site

    Normal, Illinois 61761
    United States

    Site Not Available

  • GSK Investigational Site

    New Orleans, Louisiana 20852
    United States

    Site Not Available

  • GSK Investigational Site

    Bangor, Maine 04401
    United States

    Site Not Available

  • GSK Investigational Site

    Columbia, Maryland 21044
    United States

    Site Not Available

  • GSK Investigational Site

    Warren, Michigan 48088
    United States

    Site Not Available

  • GSK Investigational Site

    Missoula, Montana 59804
    United States

    Site Not Available

  • GSK Investigational Site

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • GSK Investigational Site

    Brick, New Jersey 08724
    United States

    Site Not Available

  • GSK Investigational Site

    Linwood, New Jersey 08221
    United States

    Site Not Available

  • GSK Investigational Site

    New Windsor, New York 12553
    United States

    Site Not Available

  • GSK Investigational Site

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • GSK Investigational Site

    Charlotte, North Carolina 28273
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • GSK Investigational Site

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • GSK Investigational Site

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati, Ohio 45231
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • GSK Investigational Site

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • GSK Investigational Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • GSK Investigational Site

    Beaumont, Texas 77701
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75225
    United States

    Site Not Available

  • GSK Investigational Site

    Kerrville, Texas 78028
    United States

    Site Not Available

  • GSK Investigational Site

    Waco, Texas 76712
    United States

    Site Not Available

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