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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares two asthma treatments: FF/UMEC/VI and FF/VI. It looks at how well they improve lung function after 24 weeks, along with safety and side effects. It is for teens ages 12–17 whose asthma is not well controlled with daily treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 12–17 years old when signing the study consent or agreement form.
- Have an asthma diagnosis for at least 1 year before Visit 0.
- Have used daily inhaled steroids and a long-acting medicine that opens the airways for at least 12 weeks before Visit 0.
- Have no changes to regular asthma medicines in the 6 weeks before Visit 0. The daily steroid dose must be more than 250 and no more than 500 micrograms of fluticasone propionate, or an equal dose of another steroid.
- In the year before Visit 1, have a recorded healthcare contact for sudden asthma symptoms, or a recorded short-term treatment change under an asthma action plan.
- Have asthma that is not well controlled despite daily treatment, with an asthma control questionnaire score of at least 1.5 at Visit 1.
- At Visit 1, have a breathing test result above 40% and no more than 90% of the expected normal value before airway-opening medicine. The result must improve by at least 12% after albuterol or salbutamol.
Who can't join
- Have pneumonia confirmed by a chest X-ray in the 6 weeks before Visit 1.
- Have an asthma flare-up in the 6 weeks before Visit 1 that required a change in regular treatment or steroid pills or injections for at least 3 days. A short-term treatment change may be allowed if you return to your usual treatment and asthma condition, and the study doctor decides you can safely join.
- Have a history of life-threatening asthma.
- Have an active lung disease or lung problem other than asthma, such as pneumonia or active tuberculosis.
- Have smoked or used inhaled products for recreation in the 12 months before Visit 1. This includes cigarettes, e-cigarettes, vaping devices, cigars, and pipes, with or without nicotine.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent. * Participants who have a diagnosis of asthma as defined by the National Institutes of Health \[NIH, 2020\] at least 1 year prior to Visit 0. * Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total ICS dose of \>250 to \<=500 microgram (mcg)/day fluticasone propionate, or equivalent). * In the 1 year prior to Visit 1: A documented healthcare contact for acute asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent). * Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy. * A best pre-bronchodilator FEV1 \>40% to \<=90% of the predicted normal value and a ≥12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will be based on the European Respiratory Society (ERS) Global Lung Function Initiative. Exclusion Criteria: * Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1. * Any asthma exacerbation requiring a change in maintenance asthma therapy and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration) * History of Life-threatening Asthma * Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.). * Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco\]) within 12 months prior to Visit 1.
Study sites (28)
AL
- GSK Investigational Site · Birmingham, AL 35244US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comWeily Soong · Principal investigatorMore trials in Birmingham
- GSK Investigational Site · Mobile, AL 36608US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comLawrence Sindel · Principal investigatorMore trials in Mobile
AZ
- GSK Investigational Site · Paradise Valley, AZ 85253US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comMichael Manning · Principal investigatorMore trials in Paradise Valley
CA
- GSK Investigational Site · Bakersfield, CA 93301-4205US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comEric Boren · Principal investigatorMore trials in Bakersfield
- GSK Investigational Site · Huntington Beach, CA 92647US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comSteven Weinstein · Principal investigatorMore trials in Huntington Beach
- GSK Investigational Site · Mission Viejo, CA 92691US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comWarner Carr · Principal investigatorMore trials in Mission Viejo
- GSK Investigational Site · Rolling Hills Estates, CA 90274More trials in Rolling Hills Estates
CO
- GSK Investigational Site · Colorado Springs, CO 80909US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comEric Caplan · Principal investigatorMore trials in Colorado Springs
FL
- GSK Investigational Site · Aventura, FL 33180More trials in Aventura
- GSK Investigational Site · Miami, FL 33165US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAdalberto Aguilera · Principal investigatorMore trials in Miami
- GSK Investigational Site · Miami, FL 33173More trials in Miami
- GSK Investigational Site · Miami, FL 33174US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comFelix Penate · Principal investigatorMore trials in Miami
GA
- GSK Investigational Site · Savannah, GA 31406More trials in Savannah
IL
- GSK Investigational Site · Normal, IL 61761US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comDareen Siri · Principal investigatorMore trials in Normal
KY
- GSK Investigational Site · Owensboro, KY 42301US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comLee Clore · Principal investigatorMore trials in Owensboro
MO
- GSK Investigational Site · Columbia, MO 65203More trials in Columbia
MT
- GSK Investigational Site · Missoula, MT 59808US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comCarl Thornblade · Principal investigatorMore trials in Missoula
NY
- GSK Investigational Site · The Bronx, NY 10461-1119US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comDenise Serebrisky · Principal investigatorMore trials in The Bronx
OH
- GSK Investigational Site · Cincinnati, OH 45229US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comTheresa Guilbert · Principal investigatorMore trials in Cincinnati
- GSK Investigational Site · Cleveland, OH 44106US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comKristie Ross · Principal investigatorMore trials in Cleveland
- GSK Investigational Site · Dayton, OH 45404More trials in Dayton
OK
- GSK Investigational Site · Oklahoma City, OK 73120-9350US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comMartha Tarpay · Principal investigatorMore trials in Oklahoma City
SC
- GSK Investigational Site · Charleston, SC 29420US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comPatricia Gerber · Principal investigatorMore trials in Charleston
TX
- GSK Investigational Site · Dallas, TX 75225-6301US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comBarbara Baxter · Principal investigatorMore trials in Dallas
- GSK Investigational Site · Kerrville, TX 78028US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comDale Mohar · Principal investigatorMore trials in Kerrville
- GSK Investigational Site · Plano, TX 75034More trials in Plano
- GSK Investigational Site · Waco, TX 76712More trials in Waco
WI
- GSK Investigational Site · Milwaukee, WI 53226US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comHeidi Zafra · Principal investigatorMore trials in Milwaukee