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Study of FF/UMEC/VI for Asthma in Adolescents

This study is looking at how well two different asthma medications, FF/UMEC/VI and FF/VI, work in teenagers aged 12 to 17. Both medications are given using an ELLIPTA inhaler. The main goal is to see if FF/UMEC/VI improves lung function more than FF/VI after 24 weeks of treatment. You might be able to join if you are 12-17 years old, have had asthma for at least a year, and currently use daily inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABA). The study aims to enroll 292 participants, but its current status is unclear.

Study design
This is an interventional study comparing two different drug treatments for asthma. It plans to enroll 292 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in lung function at Week 24.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05757102

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

Recruiting
PHASE3Ages 12–17InterventionalTreatment
GlaxoSmithKline
~292 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:FF/UMEC/VIELLIPTAFF/VI

At a glance

Recruiting sites
53 of 62 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Measured over Baseline (Week 0) and Week 24

Conditions

Asthma

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Asthma

Where it's being run

62 sites across 25 states
Argentina14
Florida4
Texas4
Israel4
South Korea4
Turkey (Türkiye)4
California3
Ohio3

Study leadership

  • GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24Baseline (Week 0) and Week 24

    FEV1 will be measured using spirometry.