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Recruiting NCT05757102

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

Phase III Interventional Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FF/UMEC/VI, ELLIPTA, FF/VI.
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Chile, Israel +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug FF/UMEC/VI
    FF/UMEC/VI will be administered.
  • Device ELLIPTA
    FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
  • Drug FF/VI
    FF/VI will be administered.

Primary outcome measures

  • Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24 [Time frame: Baseline (Week 0) and Week 24]
Secondary outcome measures (6)
  • Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale) [Time frame: 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]
  • Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale) [Time frame: Baseline (Week 0) and Week 24]
  • Number of Participants with a clinically important change from baseline in ACQ-7 Score [Time frame: Week 24]
  • Number of Participants with a clinically important change from baseline in ACQ-6 Score [Time frame: Week 24]
  • Number of Participants with a clinically important change from baseline in ACQ-5 Score [Time frame: Week 24]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 26 centers
  • GSK Investigational Site — Birmingham
  • GSK Investigational Site — Mobile
  • GSK Investigational Site — Paradise Valley
  • GSK Investigational Site — Bakersfield
  • GSK Investigational Site — Mission Viejo
  • GSK Investigational Site — Rolling Hills Estates
  • GSK Investigational Site — Colorado Springs
  • GSK Investigational Site — Aventura
  • … and 18 more centers
Argentina · 14 centers
  • GSK Investigational Site — Buenos Aires
  • GSK Investigational Site — Buenos Aires
  • GSK Investigational Site — Buenos Aires
  • GSK Investigational Site — Buenos Aires
  • GSK Investigational Site — Buenos Aires
  • GSK Investigational Site — Córdoba
  • GSK Investigational Site — Lanus
  • GSK Investigational Site — Lobos
  • … and 6 more centers
Israel · 4 centers
  • GSK Investigational Site — Ashkelon
  • GSK Investigational Site — Haifa
  • GSK Investigational Site — Haifa
  • GSK Investigational Site — Petah Tikva
South Korea · 4 centers
  • GSK Investigational Site — Cheongju Chungcheongbuk-do
  • GSK Investigational Site — Seoul
  • GSK Investigational Site — Seoul
  • GSK Investigational Site — Seoul
Turkey (Türkiye) · 4 centers
  • GSK Investigational Site — Adana
  • GSK Investigational Site — Antalya
  • GSK Investigational Site — Istanbul
  • GSK Investigational Site — Istanbul
Australia · 3 centers
  • GSK Investigational Site — South Brisbane
  • GSK Investigational Site — North Adelaide
  • GSK Investigational Site — Joondalup WA
Chile · 3 centers
  • GSK Investigational Site — Lo Barnechea
  • GSK Investigational Site — Santiago
  • GSK Investigational Site — Santiago
Mexico · 3 centers
  • GSK Investigational Site — Guadalajara
  • GSK Investigational Site — Monterrey
  • GSK Investigational Site — San Juan del Río
New Zealand · 1 center
  • GSK Investigational Site — Ebdentown

Identifiers

NCT: NCT05757102 · 206867

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗