What is FF/UMEC/VI studying for asthma in adolescents?

This trial studies the combination of Fluticasone Furoate, Umeclidinium, and Vilanterol to see how it affects lung function compared to Fluticasone Furoate and Vilanterol alone in adolescents aged 12 to 17 with asthma. The research evaluates efficacy, safety, and tolerability to better understand treatment options for this age group. GlaxoSmithKline is sponsoring the study.

Who may be eligible for this asthma clinical trial?

Participants must be between 12 and 17 years old with a diagnosis of asthma for at least one year. They should be on stable inhaled corticosteroid and long-acting beta2-agonist therapy without recent medication changes and not currently smoking or using recreational inhaled products. Please review eligibility criteria for more details.

Is there any cost to participate in this asthma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal expenses such as travel to the study site may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 12Years - 17Years

All Genders

ID05757102

Phase 3 Study Comparing Effects of FFUMECVI and FFVI on Lung Function in 12- to 17-Year-Olds With Asthma Over 24 Weeks

Led by GlaxoSmithKline · Updated on 2026-07-16

292

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

The trial investigates the effects of a combination treatment using Fluticasone Furoate FF, Umeclidinium UMEC, and Vilanterol VI on lung function compared to a combination of FF and VI alone. The study focuses on adolescents aged 12 to 17 years with asthma that is not adequately controlled despite stable maintenance therapy with inhaled corticosteroids and long-acting beta2-agonists. The research aims to assess efficacy, safety, tolerability, and pharmacokinetics over a 24-week period in this age group. Participants receive either the FFUMECVI combination or the FFVI combination, both administered via the ELLIPTA inhaler. The study is randomized, double-blind, and conducted in parallel groups. Treatments are given daily, and the trial lasts for 24 weeks to monitor the effects on lung function and asthma control. During the study, participants undergo lung function tests measuring forced expiratory volume in 1 second FEV1 at the start and after 24 weeks. Additional assessments include asthma control questionnaires at baseline and week 24 to evaluate changes in symptoms. Safety and tolerability are monitored throughout, with the total participation lasting 24 weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 12Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant must be 12 to 17 years old at the time of signing consent or assent
Diagnosed with asthma at least 1 year prior to first visit
On daily inhaled corticosteroids and long-acting beta2-agonists for at least 12 weeks with no maintenance medication changes in the last 6 weeks
Had a healthcare contact or temporary change in asthma therapy for acute symptoms in the past year
Asthma inadequately controlled with ACQ-6 score ≥1.5 despite ICS/LABA
Pre-bronchodilator FEV1 >40% to ≤90% of predicted normal and at least 12% increase after albuterol at first visit

You will not qualify if you...

Pneumonia documented by chest X-ray within 6 weeks prior to first visit
Asthma exacerbation requiring systemic corticosteroids or therapy change for at least 3 days within 6 weeks prior to first visit (unless stable and resumed baseline therapy)
History of life-threatening asthma
Active pulmonary diseases or abnormalities other than asthma
Current smokers or users of inhaled recreational products within 12 months prior to first visit

Research Team

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here