A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

NCT05757102 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 206867
• Study Type: interventional
• Target: 292
• Locations: 6 countries
• Sites: 42

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.

Conditions

Asthma

Keywords

Fluticasone Furoate; GW685698; Umeclidinium; GSK573719; Vilanterol; GW642444; Trelegy; Relvar; Breo

Outcome Measures

Primary Outcomes (1)

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

  FEV1 will be measured using spirometry.

  Baseline (Week 0) and Week 24

Secondary Outcomes (6)

• 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

Study Arms (2)

Participants receiving FF/UMEC/VI

EXPERIMENTAL

Drug: FF/UMEC/VI; Device: ELLIPTA

Participants receiving FF/VI

ACTIVE COMPARATOR

Device: ELLIPTA; Drug: FF/VI

Interventions

FF/UMEC/VI DRUG

FF/UMEC/VI will be administered.

Participants receiving FF/UMEC/VI

ELLIPTA DEVICE

FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler

Participants receiving FF/UMEC/VI; Participants receiving FF/VI

FF/VI DRUG

FF/VI will be administered.

Participants receiving FF/VI

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (42)

GSK Investigational Site

Birmingham, Alabama, 35209, United States

RECRUITING

GSK Investigational Site

Mobile, Alabama, 36608, United States

RECRUITING

GSK Investigational Site

Paradise Valley, Arizona, 85253, United States

RECRUITING

GSK Investigational Site

Bakersfield, California, 93301, United States

RECRUITING

GSK Investigational Site

Huntington Beach, California, 92647, United States

WITHDRAWN

GSK Investigational Site

Mission Viejo, California, 92691, United States

RECRUITING

GSK Investigational Site

Rolling Hills Estates, California, 90274, United States

COMPLETED

GSK Investigational Site

Walnut Creek, California, 94598, United States

WITHDRAWN

GSK Investigational Site

Colorado Springs, Colorado, 80909, United States

RECRUITING

GSK Investigational Site

Aventura, Florida, 33180, United States

COMPLETED

GSK Investigational Site

Miami, Florida, 33165, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33173, United States

COMPLETED

GSK Investigational Site

Miami, Florida, 33174, United States

RECRUITING

GSK Investigational Site

Savannah, Georgia, 31406, United States

COMPLETED

GSK Investigational Site

Normal, Illinois, 61761, United States

RECRUITING

GSK Investigational Site

Owensboro, Kentucky, 42301, United States

RECRUITING

GSK Investigational Site

Columbia, Missouri, 65203, United States

COMPLETED

GSK Investigational Site

Missoula, Montana, 59808, United States

RECRUITING

GSK Investigational Site

The Bronx, New York, 10461, United States

RECRUITING

GSK Investigational Site

Cincinnati, Ohio, 45229, United States

RECRUITING

GSK Investigational Site

Cleveland, Ohio, 44106, United States

RECRUITING

GSK Investigational Site

Dayton, Ohio, 45404, United States

COMPLETED

GSK Investigational Site

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

GSK Investigational Site

Charleston, South Carolina, 29420, United States

RECRUITING

GSK Investigational Site

Dallas, Texas, 75225-6301, United States

RECRUITING

GSK Investigational Site

Kerrville, Texas, 78028, United States

RECRUITING

GSK Investigational Site

Plano, Texas, 75034, United States

COMPLETED

GSK Investigational Site

Waco, Texas, 76712, United States

COMPLETED

GSK Investigational Site

Buenos Aires, C1023AAB, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, C1425BEN, Argentina

RECRUITING

GSK Investigational Site

Rosario, 2000, Argentina

RECRUITING

GSK Investigational Site

San Miguel de Tucumán, T4000IHE, Argentina

RECRUITING

GSK Investigational Site

South Brisbane, Queensland, 4101, Australia

RECRUITING

GSK Investigational Site

Joondalup WA, Western Australia, 6027, Australia

RECRUITING

GSK Investigational Site

Santiago, 8320000, Chile

RECRUITING

GSK Investigational Site

Ebdentown, 5018, New Zealand

RECRUITING

GSK Investigational Site

Cheongju Chungcheongbuk-do, 28644, South Korea

RECRUITING

GSK Investigational Site

Gwangju, 501-757, South Korea

WITHDRAWN

GSK Investigational Site

Seoul, 03722, South Korea

COMPLETED

GSK Investigational Site

Seoul, 05505, South Korea

RECRUITING

GSK Investigational Site

Seoul, 1757, South Korea

WITHDRAWN

GSK Investigational Site

Seoul, 2447, South Korea

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: April 25, 2023
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

AU (2); AR (4); CL (1); NZ (1); KR (6); US (28)