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Corticosteroid/Anticholinergic/Beta2-agonist Combination

Triple Therapy vs Dual Therapy for Asthma

Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Must not have
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.
Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial evaluates the effects of a 3-drug combo for lung function vs. a 2-drug combo after 24 weeks of use.

Who is the study for?
This trial is for 12-17 year-olds with poorly controlled asthma despite using inhaled steroids and long-acting beta agonists. They should have had a recent healthcare visit for asthma or a change in therapy, but no pneumonia or other lung diseases recently. Smokers or those with life-threatening asthma can't join.
What is being tested?
The study compares the effects of two inhalers on lung function over 24 weeks: one combines Fluticasone Furoate (FF), Umeclidinium (UMEC), and Vilanterol (VI) while the other has just FF and VI.
What are the potential side effects?
Possible side effects include respiratory infections, headaches, throat irritation, hoarseness, thrush in the mouth and throat, bronchitis, sinusitis, and an increased risk of pneumonia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My asthma is not well-controlled despite using my regular inhalers.
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My lung function is between 40% and 90% of the expected level and improves with a specific inhaler.
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I've been on a stable asthma treatment with specific meds for at least 12 weeks.
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I am between 12 and 17 years old and can sign the consent form.
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I have been diagnosed with asthma for at least a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not smoked or used any inhaled recreational products in the last year.
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I have lung problems other than asthma, like pneumonia or tuberculosis.
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I have had severe asthma attacks that were life-threatening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Secondary study objectives
Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)
Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)
Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving FF/UMEC/VIExperimental Treatment2 Interventions
Group II: Participants receiving FF/VIActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FF/UMEC/VI
2022
Completed Phase 4
~7120
ELLIPTA
2018
Completed Phase 4
~2870

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,805 Previous Clinical Trials
8,379,211 Total Patients Enrolled
301 Trials studying Asthma
500,330 Patients Enrolled for Asthma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,579 Total Patients Enrolled
230 Trials studying Asthma
402,059 Patients Enrolled for Asthma

Media Library

FF/UMEC/VI (Corticosteroid/Anticholinergic/Beta2-agonist Combination) Clinical Trial Eligibility Overview. Trial Name: NCT05757102 — Phase 3
Asthma Research Study Groups: Participants receiving FF/UMEC/VI, Participants receiving FF/VI
Asthma Clinical Trial 2023: FF/UMEC/VI Highlights & Side Effects. Trial Name: NCT05757102 — Phase 3
FF/UMEC/VI (Corticosteroid/Anticholinergic/Beta2-agonist Combination) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757102 — Phase 3
~173 spots leftby Jan 2027
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