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A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
Sponsor: GlaxoSmithKline
Summary
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
Official title: 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
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
292
Start Date
2023-04-25
Completion Date
2027-01-15
Last Updated
2025-10-07
Healthy Volunteers
No
Conditions
Interventions
FF/UMEC/VI
FF/UMEC/VI will be administered.
ELLIPTA
FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
FF/VI
FF/VI will be administered.
Locations (42)
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Paradise Valley, Arizona, United States
GSK Investigational Site
Bakersfield, California, United States
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Mission Viejo, California, United States
GSK Investigational Site
Rolling Hills Estates, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Colorado Springs, Colorado, United States
GSK Investigational Site
Aventura, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Savannah, Georgia, United States
GSK Investigational Site
Normal, Illinois, United States
GSK Investigational Site
Owensboro, Kentucky, United States
GSK Investigational Site
Columbia, Missouri, United States
GSK Investigational Site
Missoula, Montana, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Kerrville, Texas, United States
GSK Investigational Site
Plano, Texas, United States
GSK Investigational Site
Waco, Texas, United States
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Rosario, Argentina
GSK Investigational Site
San Miguel de Tucumán, Argentina
GSK Investigational Site
South Brisbane, Queensland, Australia
GSK Investigational Site
Joondalup WA, Western Australia, Australia
GSK Investigational Site
Santiago, Chile
GSK Investigational Site
Ebdentown, New Zealand
GSK Investigational Site
Cheongju Chungcheongbuk-do, South Korea
GSK Investigational Site
Gwangju, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea