Phase
Condition
Asthma
Treatment
FF/UMEC/VI
FF/VI
ELLIPTA
Clinical Study ID
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be 12 to 17 years of age (inclusive), at the time of signing theinformed consent/assent.
Participants who have a diagnosis of asthma as defined by the National Institutes ofHealth [NIH, 2020] at least 1 year prior to Visit 0.
Participants who have required daily Inhaled corticosteroids (ICS)/ Long-ActingBeta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with nochanges to maintenance asthma medications during the 6 weeks immediately prior toVisit 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 asthmasymptoms; OR A documented temporary change in asthma therapy for acute asthmasymptoms, 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 bebased on the European Respiratory Society (ERS) Global Lung Function Initiative.
Exclusion
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 theuse 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., oralcorticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeksprior to Visit 1 are not explicitly excluded at Visit 1 provided that, at theInvestigator's discretion, the participant's condition is stable after they haveresumed their pre-exacerbation maintenance asthma therapy (without modification),returned to their baseline asthma status and they are considered appropriate forenrollment into this study of up to 6 months duration)
History of Life-threatening Asthma
Participants with current evidence of active pulmonary diseases or abnormalitiesother than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis,etc.).
Current smokers and users of other inhaled products for recreation with or withoutnicotine (defined as participants who use cigarettes, e-cigarettes,other/vaping-related devices, cigars or pipe tobacco]) within 12 months prior toVisit 1.
Study Design
Connect with a study center
GSK Investigational Site
Ciudad Autonoma Buenos aires, Buenos Aires C1046AAQ
ArgentinaSite Not Available
GSK Investigational Site
Florencio Varela, Buenos Aires 1888
ArgentinaSite Not Available
GSK Investigational Site
Florencio Varela, Buenos Aires 1888
ArgentinaSite Not Available
GSK Investigational Site
Florida, Buenos Aires 1602
ArgentinaSite Not Available
GSK Investigational Site
Lanús, Buenos Aires B1824KAJ
ArgentinaSite Not Available
GSK Investigational Site
Lobos, Buenos Aires 7240
ArgentinaSite Not Available
GSK Investigational Site
Mar del Plata, Buenos Aires 7600
ArgentinaSite Not Available
GSK Investigational Site
Almagro, Caba C1202
ArgentinaSite Not Available
GSK Investigational Site
San Rafael, Mendoza 5600
ArgentinaSite Not Available
GSK Investigational Site
Vistalba, Mendoza 5509
ArgentinaSite Not Available
GSK Investigational Site
Rosario, Santa Fe 2000
ArgentinaSite Not Available
GSK Investigational Site
San Miguel de Tucuman, Tucuman T4000IAI
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, 1122
ArgentinaSite Not Available
GSK Investigational Site
San Miguel de TucumAn, T4000IHE
ArgentinaActive - Recruiting
GSK Investigational Site
Santa Fe, 3000
ArgentinaSite Not Available
GSK Investigational Site
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
GSK Investigational Site
North Adelaide, South Australia 5006
AustraliaSite Not Available
GSK Investigational Site
Burnie, Tasmania 7320
AustraliaSite Not Available
GSK Investigational Site
Melbourne, Victoria 3052
AustraliaSite Not Available
GSK Investigational Site
Joondalup, Western Australia 6027
AustraliaSite Not Available
GSK Investigational Site
Joondalup WA, Western Australia 6027
AustraliaActive - Recruiting
GSK Investigational Site
Santiago, 7630000
ChileSite Not Available
GSK Investigational Site
Cheongju-si, Chungcheongbuk-do 28644
Korea, Republic ofSite Not Available
GSK Investigational Site
Cheongju Chungcheongbuk-do, 28644
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Gwangju, 501-757
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Incheon, 400 711
Korea, Republic ofSite Not Available
GSK Investigational Site
Seongnam, 463-712
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, 05505
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Guadalajara, Jalisco 44100
MexicoSite Not Available
GSK Investigational Site
Zapopan, Jalisco 45070
MexicoSite Not Available
GSK Investigational Site
Monterrey, Nuevo León 64460
MexicoSite Not Available
GSK Investigational Site
San Juan del Río, Querétaro 76800
MexicoSite Not Available
GSK Investigational Site
Chihuahua, 31203
MexicoSite Not Available
GSK Investigational Site
Ciudad de Mexico, 06720
MexicoSite Not Available
GSK Investigational Site
Mexico City, 04530
MexicoSite Not Available
GSK Investigational Site
Ebdentown, 5018
New ZealandActive - Recruiting
GSK Investigational Site
Adana, Cukurova 1173
TurkeySite Not Available
GSK Investigational Site
Ankara, 6230
TurkeySite Not Available
GSK Investigational Site
Istanbul, 34899
TurkeySite Not Available
GSK Investigational Site
Konyaalti, 07070
TurkeySite Not Available
GSK Investigational Site
Birmingham, Alabama 35209
United StatesActive - Recruiting
GSK Investigational Site
Mobile, Alabama 36608
United StatesActive - Recruiting
GSK Investigational Site
Paradise Valley, Arizona 85253
United StatesActive - Recruiting
GSK Investigational Site
Phoenix, Arizona 85014
United StatesSite Not Available
GSK Investigational Site
Bakersfield, California 93301
United StatesActive - Recruiting
GSK Investigational Site
Huntington Beach, California 92647
United StatesSite Not Available
GSK Investigational Site
Mission Viejo, California 92691
United StatesActive - Recruiting
GSK Investigational Site
Rolling Hills Estates, California 90274
United StatesCompleted
GSK Investigational Site
Walnut Creek, California 94598
United StatesSite Not Available
GSK Investigational Site
Colorado Springs, Colorado 80909
United StatesActive - Recruiting
GSK Investigational Site
Denver, Colorado 80206
United StatesSite Not Available
GSK Investigational Site
Aventura, Florida 33180
United StatesCompleted
GSK Investigational Site
Miami, Florida 33174
United StatesActive - Recruiting
GSK Investigational Site
Miami Lakes, Florida 33016
United StatesSite Not Available
GSK Investigational Site
Orlando, Florida 32822
United StatesSite Not Available
GSK Investigational Site
Savannah, Georgia 31406
United StatesActive - Recruiting
GSK Investigational Site
Normal, Illinois 61761
United StatesActive - Recruiting
GSK Investigational Site
Louisville, Kentucky 40202
United StatesSite Not Available
GSK Investigational Site
Owensboro, Kentucky 42301
United StatesActive - Recruiting
GSK Investigational Site
Columbia, Missouri 65203
United StatesActive - Recruiting
GSK Investigational Site
Missoula, Montana 59808
United StatesActive - Recruiting
GSK Investigational Site
Ocean City, New Jersey 07712
United StatesSite Not Available
GSK Investigational Site
Albany, New York 12208
United StatesSite Not Available
GSK Investigational Site
Bronx, New York 10461
United StatesActive - Recruiting
GSK Investigational Site
E. Amherst, New York 14051
United StatesSite Not Available
GSK Investigational Site
Cincinnati, Ohio 45229
United StatesActive - Recruiting
GSK Investigational Site
Cleveland, Ohio 44106
United StatesActive - Recruiting
GSK Investigational Site
Dayton, Ohio 45404
United StatesActive - Recruiting
GSK Investigational Site
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
GSK Investigational Site
Charleston, South Carolina 29420
United StatesActive - Recruiting
GSK Investigational Site
North Charleston, South Carolina 29420
United StatesSite Not Available
GSK Investigational Site
Boerne, Texas 78006
United StatesSite Not Available
GSK Investigational Site
Dallas, Texas 75225-6301
United StatesActive - Recruiting
GSK Investigational Site
Frisco, Texas 75034
United StatesSite Not Available
GSK Investigational Site
Kerrville, Texas 78028
United StatesActive - Recruiting
GSK Investigational Site
Plano, Texas 75034
United StatesCompleted
GSK Investigational Site
Waco, Texas 76712
United StatesCompleted
GSK Investigational Site
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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