RecruitingPhase 3NCT05757102

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

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

Sponsor

GlaxoSmithKline

Enrollment

292 participants

Start Date

Apr 25, 2023

Study Type

INTERVENTIONAL

Conditions

Asthma

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.

Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a three-drug inhaler combination (fluticasone furoate + umeclidinium + vilanterol, or FF/UMEC/VI) with a two-drug inhaler (FF/VI alone) in teenagers with asthma that is not fully controlled on their current inhalers, to see if the three-drug option improves breathing. **You may be eligible if...** - You are between 12 and 17 years old - You have been diagnosed with asthma for at least 1 year - You have been using a daily inhaled corticosteroid and long-acting beta-agonist (ICS/LABA) inhaler for at least 12 weeks with no medication changes in the last 6 weeks - Your asthma is not fully controlled on your current medications **You may NOT be eligible if...** - You are younger than 12 or 18 or older - You have been diagnosed with asthma for less than 1 year - You recently changed your asthma medications - You have other serious lung conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFF/UMEC/VI

FF/UMEC/VI will be administered.

DEVICEELLIPTA

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

DRUGFF/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

View Full Details on ClinicalTrials.gov

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NCT05757102

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