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RECRUITING
NCT05757102
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

FF/UMEC/VI

FF/UMEC/VI will be administered.

DEVICE

ELLIPTA

FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler

DRUG

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