← Back to Search

Combination Therapy

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) for Asthma

Phase 4

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1), week 24 and week 52

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am currently using daily asthma medication, either alone or with a LABA.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in trough forced expiratory volume in 1 second (FEV1)

Secondary outcome measures

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

+17 more

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,758 Previous Clinical Trials

8,102,994 Total Patients Enrolled

296 Trials studying Asthma

447,222 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people who have surpassed the age of 50 years considered suitable candidates for participation in this medical research study?

"Participants eligible for this study must be between the ages of 18 and 75. Noteworthy is that there are a total of 133 trials catered to individuals under 18 years old, while there are 208 trials targeting those over the age of 65."

Answered by AI

Is the recruitment for this study still ongoing at present?

"As per clinicaltrials.gov, this medical trial is currently not in the recruitment phase. It was initially listed on April 16th, 2024, with the latest update dated April 15th, 2024. Despite its inactive status, there are a total of 322 alternative studies actively seeking participants at present."

Answered by AI

Are multiple sites conducting this research study within the state?

"As of now, the clinical trial is operational in 56 different locations. These sites are situated not only in Newport Beach, Orlando, and Little Rock but also across an additional 53 diverse areas. Opting for a site nearby can reduce your travel commitments when engaging in this study."

Answered by AI

What are the potential risks associated with Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) in individuals?

"As this is a Phase 4 trial, indicating the treatment has already received approval, our team at Power rates the safety of Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) as 3 on our scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma

2024. "Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06372496.