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A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
NCT05757102 · GlaxoSmithKline
In plain English
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Official title
A Phase 3, 24-week, Randomized, Double-blind, Parallel-group Bayesian Dynamic Borrowing Study Comparing the Efficacy, Safety, Tolerability and Pharmacokinetics of FF/UMEC/VI With FF/VI in 12-17-year-old Participants With Inadequately Controlled Asthma on Stable Maintenance Therapy With ICS/LABA
About this study
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 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.
Study design
Enrollment target: 292 participants
Allocation: randomized
Masking: double
Age groups: child
Timeline
Starts: 2023-04-25
Estimated completion: 2027-01-15
Last updated: 2025-10-07
Interventions
Drug: FF/UMEC/VIDevice: ELLIPTADrug: FF/VI
Primary outcomes
- • Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24 (Baseline (Week 0) and Week 24)
Sponsor
GlaxoSmithKline · industry
Contacts & investigators
ContactUS GSK Clinical Trials Call Center · contact · GSKClinicalSupportHD@gsk.com · 877-379-3718
ContactEU GSK Clinical Trials Call Center · contact · GSKClinicalSupportHD@gsk.com · +44 (0) 20 89904466
InvestigatorGSK Clinical Trials · study_director, GlaxoSmithKline
All locations (42)
GSK Investigational SiteRecruiting
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Paradise Valley, Arizona, United States
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Bakersfield, California, United States
GSK Investigational SiteWithdrawn
Huntington Beach, California, United States
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Mission Viejo, California, United States
GSK Investigational SiteCompleted
Rolling Hills Estates, California, United States
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Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
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Aventura, Florida, United States
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Miami, Florida, United States
GSK Investigational SiteCompleted
Miami, Florida, United States
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Miami, Florida, United States
GSK Investigational SiteCompleted
Savannah, Georgia, United States
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Normal, Illinois, United States
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Owensboro, Kentucky, United States
GSK Investigational SiteCompleted
Columbia, Missouri, United States
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Missoula, Montana, United States
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The Bronx, New York, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
GSK Investigational SiteCompleted
Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Charleston, South Carolina, United States
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Dallas, Texas, United States
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Kerrville, Texas, United States
GSK Investigational SiteCompleted
Plano, Texas, United States
GSK Investigational SiteCompleted
Waco, Texas, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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South Brisbane, Queensland, Australia
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Joondalup WA, Western Australia, Australia
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Santiago, Chile
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Ebdentown, New Zealand
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Cheongju Chungcheongbuk-do, South Korea
GSK Investigational SiteWithdrawn
Gwangju, South Korea
GSK Investigational SiteCompleted
Seoul, South Korea
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Seoul, South Korea
GSK Investigational SiteWithdrawn
Seoul, South Korea
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Seoul, South Korea