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

July 15, 2026 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

292

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1122
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Horacio Budani
        • Contact:
        • Contact:
      • Buenos Aires, Argentina, C1425BEN
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anahi Yanez
        • Contact:
        • Contact:
      • Buenos Aires, Argentina, C1023AAB
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abel Esteban Bordon
      • Buenos Aires, Argentina, 1888
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Medina
      • Buenos Aires, Argentina, C1202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Monica Silvia De Gennaro
      • Córdoba, Argentina, X5000DCE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Victor Hugo Cambursano
      • Lanus, Argentina, B1824KAJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adriana Sosso
      • Lobos, Argentina, 7240
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fabian Dabove
      • Lujan de Cuyo, Argentina, 5509
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cristian Fazio
      • Mar del Plata, Argentina, 7600
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jorge Taborda
        • Contact:
        • Contact:
      • Rosario, Argentina, 2000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adriana Marcipar
      • Rosario Provincia de Santa FE, Argentina, 2000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriel Gattolin
      • San Miguel de Tucumán, Argentina, T4000IHE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramona Silvia del Valle Orosco Segura
      • Santa Fe, Argentina, 3000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Edgardo Roberto Maillo
  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ajay Kevat
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Tai
    • Western Australia
      • Joondalup WA, Western Australia, Australia, 6027
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Desiree Silva
  • Chile
      • Lo Barnechea, Chile, 7691236
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alberto Vidal Grell
      • Santiago, Chile, 7630000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Palomino
      • Santiago, Chile, 8320000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniela Valenzuela Venandy
  • Israel
      • Ashkelon, Israel, 7830604
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alina Avenshtein
      • Haifa, Israel, 3436212
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karin Yaacoby-Bianu
      • Haifa, Israel, 3109600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michal Gur
      • Petah Tikva, Israel, 49202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meir Mei-Zahav
  • Mexico
      • Guadalajara, Mexico, 44100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Alejandro Salazar-Quiroz
      • Monterrey, Mexico, 64460
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandra Gonzalez-Diaz
      • San Juan del Río, Mexico, 76800
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mario Rosas-Navarro
  • New Zealand
    • Upper Hutt
      • Ebdentown, Upper Hutt, New Zealand, 5018
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tim Humphrey
  • South Korea
      • Cheongju Chungcheongbuk-do, South Korea, 28644
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Youn-Soo Hahn
      • Seoul, South Korea, 05505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jinho Yu
      • Seoul, South Korea, 03722
        • Completed
        • GSK Investigational Site
      • Seoul, South Korea, 2447
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ju Kim
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 1173
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dilek Ozcan
      • Antalya, Turkey (Türkiye), 07070
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aysen Bingol
      • Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cansin Sackesen
      • Istanbul, Turkey (Türkiye), 34899
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmet Ozen
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Weily Soong
        • Contact:
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lawrence Sindel
    • Arizona
      • Paradise Valley, Arizona, United States, 85253
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michael Manning
        • Contact:
        • Contact:
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric Boren
      • Mission Viejo, California, United States, 92691
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Warner Carr
      • Rolling Hills Estates, California, United States, 90274
        • Completed
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric Caplan
    • Florida
      • Aventura, Florida, United States, 33180
        • Completed
        • GSK Investigational Site
      • Miami, Florida, United States, 33165
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adalberto Aguilera
      • Miami, Florida, United States, 33174
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Felix Penate
        • Contact:
        • Contact:
      • Miami, Florida, United States, 33173
        • Completed
        • GSK Investigational Site
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Completed
        • GSK Investigational Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dareen Siri
        • Contact:
        • Contact:
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lee Clore
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Completed
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carl Thornblade
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Denise Serebrisky
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Theresa Guilbert
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kristie Ross
        • Contact:
        • Contact:
      • Dayton, Ohio, United States, 45404
        • Completed
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martha Tarpay
    • South Carolina
      • Charleston, South Carolina, United States, 29420
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricia Gerber
    • Texas
      • Dallas, Texas, United States, 75225-6301
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Barbara Baxter
      • Kerrville, Texas, United States, 78028
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dale Mohar
        • Contact:
        • Contact:
      • Plano, Texas, United States, 75034
        • Completed
        • GSK Investigational Site
      • Waco, Texas, United States, 76712
        • Completed
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants receiving FF/UMEC/VI
Drug: FF/UMEC/VI
FF/UMEC/VI will be administered.
Device: ELLIPTA
FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
Active Comparator: Participants receiving FF/VI
Drug: FF/VI
FF/VI will be administered.
Device: ELLIPTA
FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Week 0) and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
Time Frame: Baseline (Week 0) and Week 24
ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma.
Baseline (Week 0) and Week 24
Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)
Time Frame: Baseline (Week 0) and Week 24
ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma.
Baseline (Week 0) and Week 24
Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)
Time Frame: Baseline (Week 0) and Week 24
ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma.
Baseline (Week 0) and Week 24
Number of Participants with a clinically important change from baseline in ACQ-7 Score
Time Frame: Week 24
ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score.
Week 24
Number of Participants with a clinically important change from baseline in ACQ-6 Score
Time Frame: Week 24
ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score.
Week 24
Number of Participants with a clinically important change from baseline in ACQ-5 Score
Time Frame: Week 24
ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Estimated)

January 22, 2027

Study Completion (Estimated)

January 28, 2027

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206867

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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