ELLIPTA: FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
FF/VI: FF/VI will be administered.
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
Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24 — Baseline (Week 0) and Week 24 FEV1 will be measured using spirometry.
Trial sites (67)
Facility
City
Region
Status
GSK Investigational Site
Birmingham
Alabama
Recruiting
GSK Investigational Site
Mobile
Alabama
Recruiting
GSK Investigational Site
Paradise Valley
Arizona
Recruiting
GSK Investigational Site
Bakersfield
California
Recruiting
GSK Investigational Site
Huntington Beach
California
Recruiting
GSK Investigational Site
Mission Viejo
California
Recruiting
GSK Investigational Site
Rolling Hills Estates
California
Completed
GSK Investigational Site
Colorado Springs
Colorado
Recruiting
GSK Investigational Site
Aventura
Florida
Completed
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Completed
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Savannah
Georgia
Completed
GSK Investigational Site
Normal
Illinois
Recruiting
GSK Investigational Site
Owensboro
Kentucky
Recruiting
GSK Investigational Site
Columbia
Missouri
Completed
GSK Investigational Site
Missoula
Montana
Recruiting
GSK Investigational Site
The Bronx
New York
Recruiting
GSK Investigational Site
Cincinnati
Ohio
Recruiting
GSK Investigational Site
Cleveland
Ohio
Recruiting
GSK Investigational Site
Dayton
Ohio
Completed
GSK Investigational Site
Oklahoma City
Oklahoma
Recruiting
GSK Investigational Site
Charleston
South Carolina
Recruiting
GSK Investigational Site
Dallas
Texas
Recruiting
GSK Investigational Site
Kerrville
Texas
Recruiting
GSK Investigational Site
Plano
Texas
Completed
GSK Investigational Site
Waco
Texas
Completed
GSK Investigational Site
Milwaukee
Wisconsin
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Córdoba
Argentina
Recruiting
GSK Investigational Site
Córdoba
Argentina
Recruiting
GSK Investigational Site
Lanus
Argentina
Recruiting
GSK Investigational Site
Lobos
Argentina
Recruiting
GSK Investigational Site
Lujan de Cuyo
Argentina
Recruiting
GSK Investigational Site
Mar del Plata
Argentina
Recruiting
GSK Investigational Site
Rosario
Argentina
Recruiting
+ 27 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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