A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

Last updated: May 24, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

Asthma

Treatment

FF/UMEC/VI

ELLIPTA

FF/VI

Clinical Study ID

NCT05757102
206867
  • Ages 12-17
  • All Genders

Study Summary

The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be 12 to 17 years of age (inclusive), at the time of signing theinformed consent/assent.

  • Participants who have a diagnosis of asthma as defined by the National Institutes ofHealth [NIH, 2020] at least 1 year prior to Visit 0.

  • Participants who have required daily Inhaled corticosteroids (ICS)/ Long-ActingBeta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with nochanges to maintenance asthma medications during the 6 weeks immediately prior toVisit 0 (including no changes to a stable total ICS dose of >250 to <=500 microgram (mcg)/day fluticasone propionate, or equivalent).

  • In the 1 year prior to Visit 1: A documented healthcare contact for acute asthmasymptoms; OR A documented temporary change in asthma therapy for acute asthmasymptoms, according to a prespecified asthma action plan (or equivalent).

  • Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1,despite ICS/LABA maintenance therapy.

  • A best pre-bronchodilator FEV1 >40% to <=90% of the predicted normal value and a ≥12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will bebased on the European Respiratory Society (ERS) Global Lung Function Initiative.

Exclusion

Exclusion Criteria:

  • Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.

  • Any asthma exacerbation requiring a change in maintenance asthma therapy and/or theuse of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oralcorticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeksprior to Visit 1 are not explicitly excluded at Visit 1 provided that, at theInvestigator's discretion, the participant's condition is stable after they haveresumed their pre-exacerbation maintenance asthma therapy (without modification),returned to their baseline asthma status and they are considered appropriate forenrollment into this study of up to 6 months duration)

  • History of Life-threatening Asthma

  • Participants with current evidence of active pulmonary diseases or abnormalitiesother than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis,etc.).

  • Current smokers and users of other inhaled products for recreation with or withoutnicotine (defined as participants who use cigarettes, e-cigarettes,other/vaping-related devices, cigars or pipe tobacco]) within 12 months prior toVisit 1.

Study Design

Total Participants: 292
Treatment Group(s): 3
Primary Treatment: FF/UMEC/VI
Phase: 3
Study Start date:
April 24, 2023
Estimated Completion Date:
January 15, 2027

Connect with a study center

  • GSK Investigational Site

    Ciudad Autonoma Buenos aires, Buenos Aires C1046AAQ
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Florencio Varela, Buenos Aires 1888
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Florencio Varela, Buenos Aires 1888
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Florida, Buenos Aires 1602
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Lanús, Buenos Aires B1824KAJ
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Lobos, Buenos Aires 7240
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Mar del Plata, Buenos Aires 7600
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Almagro, Caba C1202
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    San Rafael, Mendoza 5600
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Vistalba, Mendoza 5509
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    San Miguel de Tucuman, Tucuman T4000IAI
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Buenos Aires, C1425BEN
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Santa Fe, 3000
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    South Brisbane, Queensland 4101
    Australia

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  • GSK Investigational Site

    North Adelaide, South Australia 5006
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Burnie, Tasmania 7320
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Melbourne, Victoria 3052
    Australia

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  • GSK Investigational Site

    Joondalup, Western Australia 6027
    Australia

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  • GSK Investigational Site

    Santiago, Región Metro De Santiago 8320000
    Chile

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  • GSK Investigational Site

    Cheongju-si, Chungcheongbuk-do 28644
    Korea, Republic of

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  • GSK Investigational Site

    Gwangju, 501-757
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Incheon, 400 711
    Korea, Republic of

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  • GSK Investigational Site

    Seongnam, 463-712
    Korea, Republic of

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  • GSK Investigational Site

    Seoul, 2447
    Korea, Republic of

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  • GSK Investigational Site

    Guadalajara, Jalisco 44100
    Mexico

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  • GSK Investigational Site

    Zapopan, Jalisco 45070
    Mexico

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  • GSK Investigational Site

    Monterrey, Nuevo León 64460
    Mexico

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  • GSK Investigational Site

    San Juan del Río, Querétaro 76800
    Mexico

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  • GSK Investigational Site

    Chihuahua, 31203
    Mexico

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  • GSK Investigational Site

    Ciudad de Mexico, 06720
    Mexico

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  • GSK Investigational Site

    Mexico City, 04530
    Mexico

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  • GSK Investigational Site

    Adana, Cukurova 1173
    Turkey

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  • GSK Investigational Site

    Ankara, 6230
    Turkey

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  • GSK Investigational Site

    Istanbul, 34899
    Turkey

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  • GSK Investigational Site

    Konyaalti, 07070
    Turkey

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  • GSK Investigational Site

    Birmingham, Alabama 35209
    United States

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  • GSK Investigational Site

    Mobile, Alabama 36608
    United States

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  • GSK Investigational Site

    Paradise Valley, Arizona 85253
    United States

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  • GSK Investigational Site

    Phoenix, Arizona 85014
    United States

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  • GSK Investigational Site

    Bakersfield, California 93301
    United States

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  • GSK Investigational Site

    Huntington Beach, California 92647
    United States

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  • GSK Investigational Site

    Mission Viejo, California 92691
    United States

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  • GSK Investigational Site

    Rolling Hills Estates, California 90274
    United States

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  • GSK Investigational Site

    Walnut Creek, California 94598
    United States

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  • GSK Investigational Site

    Colorado Springs, Colorado 80909
    United States

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  • GSK Investigational Site

    Denver, Colorado 80206
    United States

    Active - Recruiting

  • GSK Investigational Site

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • GSK Investigational Site

    Miami, Florida 33174
    United States

    Active - Recruiting

  • GSK Investigational Site

    Miami Lakes, Florida 33016
    United States

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  • GSK Investigational Site

    Orlando, Florida 32822
    United States

    Active - Recruiting

  • GSK Investigational Site

    Savannah, Georgia 31406
    United States

    Active - Recruiting

  • GSK Investigational Site

    Normal, Illinois 61761
    United States

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  • GSK Investigational Site

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • GSK Investigational Site

    Owensboro, Kentucky 42301
    United States

    Active - Recruiting

  • GSK Investigational Site

    Columbia, Missouri 65203
    United States

    Active - Recruiting

  • GSK Investigational Site

    Missoula, Montana 59808
    United States

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  • GSK Investigational Site

    Ocean City, New Jersey 07712
    United States

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  • GSK Investigational Site

    Albany, New York 12208
    United States

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  • GSK Investigational Site

    Bronx, New York 10461
    United States

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  • GSK Investigational Site

    E. Amherst, New York 14051
    United States

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  • GSK Investigational Site

    Cincinnati, Ohio 45229
    United States

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  • GSK Investigational Site

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • GSK Investigational Site

    Dayton, Ohio 45404
    United States

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  • GSK Investigational Site

    Oklahoma City, Oklahoma 73120
    United States

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  • GSK Investigational Site

    North Charleston, South Carolina 29420
    United States

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  • GSK Investigational Site

    Boerne, Texas 78006
    United States

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  • GSK Investigational Site

    Dallas, Texas 75225-6301
    United States

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  • GSK Investigational Site

    Frisco, Texas 75034
    United States

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  • GSK Investigational Site

    Kerrville, Texas 78028
    United States

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  • GSK Investigational Site

    Waco, Texas 76712
    United States

    Active - Recruiting

  • GSK Investigational Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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