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Corticosteroid/Anticholinergic/Beta2-agonist Combination

Triple Therapy vs Dual Therapy for Asthma

Q: How many individuals are currently enrolled in this research trial?

Confirmed, the clinical trial is still in search of participants. It was originally posted on April 24th 2023 and has been updated recently on July 21st. The study requires 292 individuals to be enrolled at 15 different research sites.

Q: At which sites are the results of this experiment taking place?

This <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> trial is enrolling at fifteen different sites, including <a href="https://www.withpower.com/clinical-trials/mobile">Mobile</a>, Paradise Valley and Bakersfield. To reduce the amount of travel necessary for participation in this study it is best to select a location close to you.

Q: Are current enrolments being accepted for this experiment?

Affirmative. According to clinicaltrials.gov, this research initiative that was first published on April 24th 2023 is currently looking for volunteers. There are a total of 15 sites recruiting 292 participants in <a href="https://www.withpower.com/clinical-trials/all">all</a>.

Q: Is it possible to become a participant in this experiment?

This clinical trial is searching for 292 participants aged between 12 and 17 years old with <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a>. The primary requirements are that the candidate has had an official diagnosis of asthma from NIH [NIH, 2020], must have been receiving ICS/LABA medication on a regular basis prior to Visit 0, must have visited a healthcare service in the past year due to acute symptoms, and their FEV1 score before bronchodilator use must be no lower than 40% but no higher than 90%. Additionally they require documentation of at least one change in treatment due to an action plan or equivalent.

Q: Does eligibility for this experiment extend to those under 25 years of age?

Patients aged 12 to 17 can partake in this study, which is one of 142 trials being conducted for minors and 203 geared towards seniors.

Q: How does the FF/UMEC/VI combination therapy impact patient safety?

The safety of FF/UMEC/VI, as assessed by our team at Power, is classified as a 3 on the numerical scale. This rating is rooted in Phase 3 trial data which has revealed efficacy and security through multiple rounds of testing.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My asthma is not well-controlled despite using my regular inhalers.

Select...

My lung function is between 40% and 90% of the expected level and improves with a specific inhaler.

Select...

I've been on a stable asthma treatment with specific meds for at least 12 weeks.

Select...

I am between 12 and 17 years old and can sign the consent form.

Select...

I have been diagnosed with asthma for at least a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

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

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) (Liters) at Week 24

Secondary outcome measures

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

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

~6890

ELLIPTA

2018

Completed Phase 4

~2640

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,543 Total Patients Enrolled

295 Trials studying Asthma

416,271 Patients Enrolled for Asthma

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,648 Total Patients Enrolled

229 Trials studying Asthma

401,952 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

Frequently Asked Questions

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

How many individuals are currently enrolled in this research trial?

"Confirmed, the clinical trial is still in search of participants. It was originally posted on April 24th 2023 and has been updated recently on July 21st. The study requires 292 individuals to be enrolled at 15 different research sites."

Answered by AI

At which sites are the results of this experiment taking place?

"This experimental trial is enrolling at fifteen different sites, including Mobile, Paradise Valley and Bakersfield. To reduce the amount of travel necessary for participation in this study it is best to select a location close to you."

Answered by AI

Are current enrolments being accepted for this experiment?

"Affirmative. According to clinicaltrials.gov, this research initiative that was first published on April 24th 2023 is currently looking for volunteers. There are a total of 15 sites recruiting 292 participants in all."

Answered by AI

Is it possible to become a participant in this experiment?

"This clinical trial is searching for 292 participants aged between 12 and 17 years old with asthma. The primary requirements are that the candidate has had an official diagnosis of asthma from NIH [NIH, 2020], must have been receiving ICS/LABA medication on a regular basis prior to Visit 0, must have visited a healthcare service in the past year due to acute symptoms, and their FEV1 score before bronchodilator use must be no lower than 40% but no higher than 90%. Additionally they require documentation of at least one change in treatment due to an action plan or equivalent."

Answered by AI

Does eligibility for this experiment extend to those under 25 years of age?

"Patients aged 12 to 17 can partake in this study, which is one of 142 trials being conducted for minors and 203 geared towards seniors."

Answered by AI

How does the FF/UMEC/VI combination therapy impact patient safety?

"The safety of FF/UMEC/VI, as assessed by our team at Power, is classified as a 3 on the numerical scale. This rating is rooted in Phase 3 trial data which has revealed efficacy and security through multiple rounds of testing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05757102.

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