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NCT05757102PHASE3Recruiting

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

GlaxoSmithKline

Start Date

4/25/2023

Completion Date

1/28/2027

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

Age Range: 12 years to 17 years

Inclusion Criteria: * Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent. * Participants who have a diagnosis of asthma as defined by the National Institutes of Health \[NIH, 2020\] at least 1 year prior to Visit 0. * Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 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 asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, 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 be based on the European Respiratory Society (ERS) Global Lung Function Initiative. 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 the use 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., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration) * History of Life-threatening Asthma * Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.). * Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco\]) within 12 months prior to Visit 1.

Interventions

DRUG

FF/UMEC/VI

DEVICE

ELLIPTA

DRUG

FF/VI

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Conditions

Asthma

Locations

GSK Investigational Site

Birmingham, Alabama 35244

United States

GSK Investigational Site

Mobile, Alabama 36608

United States

GSK Investigational Site

Paradise Valley, Arizona 85253

United States

GSK Investigational Site

Bakersfield, California 93301

United States

GSK Investigational Site

Mission Viejo, California 92691

United States

GSK Investigational Site

Rolling Hills Estates, California 90274

United States

GSK Investigational Site

Colorado Springs, Colorado 80909

United States

GSK Investigational Site

Aventura, Florida 33180

United States

GSK Investigational Site

Miami, Florida 33165

United States

GSK Investigational Site

Miami, Florida 33173

United States

GSK Investigational Site

Miami, Florida 33174

United States

GSK Investigational Site

Savannah, Georgia 31406

United States

GSK Investigational Site

Normal, Illinois 61761

United States

GSK Investigational Site

Owensboro, Kentucky 42301

United States

GSK Investigational Site

Columbia, Missouri 65203

United States

GSK Investigational Site

Missoula, Montana 59808

United States

GSK Investigational Site

The Bronx, New York 10461

United States

GSK Investigational Site

Cincinnati, Ohio 45229

United States

GSK Investigational Site

Cleveland, Ohio 44106

United States

GSK Investigational Site

Dayton, Ohio 45404

United States

GSK Investigational Site

Oklahoma City, Oklahoma 73120

United States

GSK Investigational Site

Charleston, South Carolina 29420

United States

GSK Investigational Site

Dallas, Texas 75225-6301

United States

GSK Investigational Site

Kerrville, Texas 78028

United States

GSK Investigational Site

Plano, Texas 75034

United States

GSK Investigational Site

Waco, Texas 76712

United States

GSK Investigational Site

Buenos Aires, 1122

Argentina

GSK Investigational Site

Buenos Aires, 1888

Argentina

GSK Investigational Site

Buenos Aires, C1023AAB

Argentina

GSK Investigational Site

Buenos Aires, C1202

Argentina

GSK Investigational Site

Buenos Aires, C1425BEN

Argentina

GSK Investigational Site

Córdoba, X5000DCE

Argentina

GSK Investigational Site

Lanus, B1824KAJ

Argentina

GSK Investigational Site

Lobos, 7240

Argentina

GSK Investigational Site

Lujan de Cuyo, 5509

Argentina

GSK Investigational Site

Mar del Plata, 7600

Argentina

GSK Investigational Site

Rosario, 2000

Argentina

GSK Investigational Site

Rosario Provincia de Santa FE, 2000

Argentina

GSK Investigational Site

San Miguel de Tucumán, T4000IHE

Argentina

GSK Investigational Site

Santa Fe, 3000

Argentina

GSK Investigational Site

South Brisbane, Queensland 4101

Australia

GSK Investigational Site

North Adelaide, South Australia 5006

Australia

GSK Investigational Site

Joondalup WA, Western Australia 6027

Australia

GSK Investigational Site

Lo Barnechea, 7691236

Chile

GSK Investigational Site

Santiago, 7630000

Chile

GSK Investigational Site

Santiago, 8320000

Chile

GSK Investigational Site

Ashkelon, 7830604

Israel

GSK Investigational Site

Haifa, 3109600

Israel

GSK Investigational Site

Haifa, 3436212

Israel

GSK Investigational Site

Petah Tikva, 49202

Israel

GSK Investigational Site

Guadalajara, 44100

Mexico

GSK Investigational Site

Monterrey, 64460

Mexico

GSK Investigational Site

San Juan del Río, 76800

Mexico

GSK Investigational Site

Ebdentown, Upper Hutt 5018

New Zealand

GSK Investigational Site

Cheongju Chungcheongbuk-do, 28644

South Korea

GSK Investigational Site

Seoul, 03722

South Korea

GSK Investigational Site

Seoul, 05505

South Korea

GSK Investigational Site

Seoul, 2447

South Korea

GSK Investigational Site

Adana, 1173

Turkey (Türkiye)

GSK Investigational Site

Antalya, 07070

Turkey (Türkiye)

GSK Investigational Site

Istanbul, 34010

Turkey (Türkiye)

GSK Investigational Site

Istanbul, 34899

Turkey (Türkiye)