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

GlaxoSmithKline1 site in 1 country292 target enrollmentApril 25, 2023

ConditionsAsthma

InterventionsFF/UMEC/VI ELLIPTA FF/VI

DrugsFF/UMEC/VI FF/VI

Overview

Phase: Phase 3
Intervention: FF/UMEC/VI
Conditions: Asthma
Sponsor: GlaxoSmithKline
Enrollment: 292
Locations: 1
Primary Endpoint: Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Status: Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 25, 2023

End Date

January 15, 2027

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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
•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
•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
•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
•(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.

Arms & Interventions

Participants receiving FF/UMEC/VI

Intervention: FF/UMEC/VI

Participants receiving FF/UMEC/VI

Intervention: ELLIPTA

Participants receiving FF/VI

Intervention: ELLIPTA

Participants receiving FF/VI

Intervention: FF/VI

Outcomes

Primary Outcomes

Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24

Time Frame: Baseline (Week 0) and Week 24

FEV1 will be measured using spirometry.

Secondary Outcomes

Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)(Baseline (Week 0) and Week 24)
Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)(Baseline (Week 0) and Week 24)
Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)(Baseline (Week 0) and Week 24)
Number of Participants with a clinically important change from baseline in ACQ-7 Score(Week 24)
Number of Participants with a clinically important change from baseline in ACQ-6 Score(Week 24)
Number of Participants with a clinically important change from baseline in ACQ-5 Score(Week 24)