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Clinical Trials in Mexico / NCT05757102
Recruiting Phase 3

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

NCT05757102 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2023-04-24
Last updated
2026-09-30

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

FF/UMEC/VI →ELLIPTAFF/VI

FF/UMEC/VI: FF/UMEC/VI will be administered.

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)

Trial sites (67)

FacilityCityRegionStatus
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.

More GlaxoSmithKline trials in Mexico

Other trials for the same condition

Official registry record

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.

View NCT05757102 on ClinicalTrials.gov ↗ ← All trials in Mexico