Actively Recruiting
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
Led by GlaxoSmithKline · Updated on 2025-10-07
292
Participants Needed
42
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
GSK Investigational Site
Mobile, Alabama, United States, 36608
Actively Recruiting
3
GSK Investigational Site
Paradise Valley, Arizona, United States, 85253
Actively Recruiting
4
GSK Investigational Site
Bakersfield, California, United States, 93301
Actively Recruiting
5
GSK Investigational Site
Huntington Beach, California, United States, 92647
Withdrawn
6
GSK Investigational Site
Mission Viejo, California, United States, 92691
Actively Recruiting
7
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Completed
8
GSK Investigational Site
Walnut Creek, California, United States, 94598
Withdrawn
9
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
10
GSK Investigational Site
Aventura, Florida, United States, 33180
Completed
11
GSK Investigational Site
Miami, Florida, United States, 33165
Actively Recruiting
12
GSK Investigational Site
Miami, Florida, United States, 33173
Completed
13
GSK Investigational Site
Miami, Florida, United States, 33174
Actively Recruiting
14
GSK Investigational Site
Savannah, Georgia, United States, 31406
Completed
15
GSK Investigational Site
Normal, Illinois, United States, 61761
Actively Recruiting
16
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
Actively Recruiting
17
GSK Investigational Site
Columbia, Missouri, United States, 65203
Completed
18
GSK Investigational Site
Missoula, Montana, United States, 59808
Actively Recruiting
19
GSK Investigational Site
The Bronx, New York, United States, 10461
Actively Recruiting
20
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
Actively Recruiting
21
GSK Investigational Site
Cleveland, Ohio, United States, 44106
Actively Recruiting
22
GSK Investigational Site
Dayton, Ohio, United States, 45404
Completed
23
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
24
GSK Investigational Site
Charleston, South Carolina, United States, 29420
Actively Recruiting
25
GSK Investigational Site
Dallas, Texas, United States, 75225-6301
Actively Recruiting
26
GSK Investigational Site
Kerrville, Texas, United States, 78028
Actively Recruiting
27
GSK Investigational Site
Plano, Texas, United States, 75034
Completed
28
GSK Investigational Site
Waco, Texas, United States, 76712
Completed
29
GSK Investigational Site
Buenos Aires, Argentina, C1023AAB
Actively Recruiting
30
GSK Investigational Site
Buenos Aires, Argentina, C1425BEN
Actively Recruiting
31
GSK Investigational Site
Rosario, Argentina, 2000
Actively Recruiting
32
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000IHE
Actively Recruiting
33
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
34
GSK Investigational Site
Joondalup WA, Western Australia, Australia, 6027
Actively Recruiting
35
GSK Investigational Site
Santiago, Chile, 8320000
Actively Recruiting
36
GSK Investigational Site
Ebdentown, New Zealand, 5018
Actively Recruiting
37
GSK Investigational Site
Cheongju Chungcheongbuk-do, South Korea, 28644
Actively Recruiting
38
GSK Investigational Site
Gwangju, South Korea, 501-757
Withdrawn
39
GSK Investigational Site
Seoul, South Korea, 03722
Completed
40
GSK Investigational Site
Seoul, South Korea, 05505
Actively Recruiting
41
GSK Investigational Site
Seoul, South Korea, 1757
Withdrawn
42
GSK Investigational Site
Seoul, South Korea, 2447
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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