Your session is about to expire
← Back to Search
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 belowSelect...
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:Select...
I am currently taking RELVAR ELLIPTA and ARNUITY ELLIPTA.
Select...
I have been diagnosed with COPD according to the latest guidelines.
Select...
I have had severe asthma attacks recently.
Select...
I've had more than one severe asthma attack in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1), week 24 and week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), week 24 and week 52
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 moreAwards & 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
4,799 Previous Clinical Trials
8,376,480 Total Patients Enrolled
300 Trials studying Asthma
499,455 Patients Enrolled for Asthma
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger