Actively Recruiting
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
62
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
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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