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Combination Therapy

Triple Therapy for Uncontrolled Asthma

Phase 4
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently untreated or treated with daily maintenance ICS or ICS/LABA
Be older than 18 years old
Must not have
Current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA
Diagnosis of chronic obstructive pulmonary disease as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), week 24 and week 52
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

"This trial aims to see how well a new medication, FF/UMEC/VI, works compared to the standard treatment, ICS/LABA, in adults with uncontrolled asthma."

Who is the study for?
Adults with uncontrolled asthma are eligible for this trial. Specific details about inclusion and exclusion criteria were not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose a risk.
What is being tested?
The trial is testing the effectiveness of a combination inhaler (FF/UMEC/VI) against usual care inhaled corticosteroids plus long-acting beta-2 agonists (ICS/LABA). It's an open-label, randomized study where patients are assigned to treatments by chance.
What are the potential side effects?
Common side effects may include respiratory infections, headaches, bronchitis, inflammation of sinuses or throat irritation. Each individual might experience different side effects based on their reaction to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently using daily asthma medication, either alone or with a LABA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking RELVAR ELLIPTA and ARNUITY ELLIPTA.
Select...
I have been diagnosed with COPD according to the latest guidelines.
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I have had severe asthma attacks recently.
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I've had more than one severe asthma attack in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), week 24 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), week 24 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment
Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment
Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment
+14 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI)Experimental Treatment1 Intervention
Group II: Inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA)Active Control1 Intervention

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,807 Previous Clinical Trials
8,380,182 Total Patients Enrolled
301 Trials studying Asthma
499,376 Patients Enrolled for Asthma
~757 spots leftby Mar 2026
Unbiased ResultsWe believe in providing patients with all the options.
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