GSK Trelegy Ellipta vs BREO Ellipta - ARIA Protocol 206867 Fluticasone (FF)/Vilanterol (VI) 100/25mcg VS Fluticasone (FF)/Umeclindinium (UMEC)/Vilanterol (VI) 100/62.5/25mcg Inhalation (GSK 206867)
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
- Sex: Any
- Age: Child (Birth - 17)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase III
- Conditions Being Studied: Lung, Asthma
Study Purpose
The purpose of this study is to see if the study drug, a GSK drug, can be given to those under age 18 to treat asthma. The study drug will be compared with another GSK drug which is a combination of 2 medicines (FF and VI) in a single Ellipta inhaler.
Who Can Participate
Age: 12-17 years old
Locations
UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106
- UH IRB: SITE00001981
- StudyID: 2023-01171
- ClinicalTrials.gov: NCT05757102
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