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Comparing two asthma treatments in teenagers

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

Phase 3 Interventional GlaxoSmithKline · NCT05757102

This study is testing if a new combination asthma treatment helps teenagers aged 12 to 17 breathe better and manage their symptoms compared to a standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment292 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Locations42 sites (Birmingham, Alabama and 41 other locations)
Trial IDNCT05757102 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, and tolerability of a combination treatment of Fluticasone Furoate, Umeclidinium, and Vilanterol (FF/UMEC/VI) compared to a combination of Fluticasone Furoate and Vilanterol (FF/VI) in adolescents aged 12 to 17 with asthma. Participants will receive one of the treatments for 24 weeks, and their lung function will be monitored to assess the effectiveness of the therapies. The study aims to determine if the new combination provides better outcomes for managing asthma symptoms.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to 17 with a diagnosis of asthma requiring daily inhaled corticosteroids and long-acting beta2-agonists.

Not a fit: Patients with well-controlled asthma or those not requiring daily asthma medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved asthma management options for adolescents, enhancing their quality of life.

How similar studies have performed: Previous studies have shown promising results with similar combination therapies for asthma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaFluticasone FuroateGW685698UmeclidiniumGSK573719VilanterolGW642444Trelegy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.