Clinical trial NCT05757102: A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Asthma
Keywords: Fluticasone Furoate
GW685698
Umeclidinium
GSK573719
Vilanterol
GW642444
Trelegy
Relvar
Breo
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 292
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
timeFrame: Baseline (Week 0) and Week 24
Secondary outcomes:
measure: Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
timeFrame: Baseline (Week 0) and Week 24
measure: Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)
timeFrame: Baseline (Week 0) and Week 24
measure: Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)
timeFrame: Baseline (Week 0) and Week 24
measure: Number of Participants with a clinically important change from baseline in ACQ-7 Score
timeFrame: Week 24
measure: Number of Participants with a clinically important change from baseline in ACQ-6 Score
timeFrame: Week 24
measure: Number of Participants with a clinically important change from baseline in ACQ-5 Score
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Paradise Valley
country: United States
facility: GSK Investigational Site
state: Arizona
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Mission Viejo
country: United States
facility: GSK Investigational Site
state: California
city: Rolling Hills Estates
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Aventura
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Normal
country: United States
facility: GSK Investigational Site
state: Illinois
city: Owensboro
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Columbia
country: United States
facility: GSK Investigational Site
state: Missouri
city: Missoula
country: United States
facility: GSK Investigational Site
state: Montana
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Kerrville
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: Waco
country: United States
facility: GSK Investigational Site
state: Texas
city: San Miguel de TucumAn
country: Argentina
facility: GSK Investigational Site
city: South Brisbane
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Joondalup WA
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Cheongju Chungcheongbuk-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gwangju
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Ebdentown
country: New Zealand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: