What side effects are associated with this type of intervention?

Common side effects of asthma treatments similar to the triple therapy inhaler (Fluticasone Furoate, Umeclidinium, Vilanterol) include oral thrush and hoarseness from Fluticasone Furoate, dry mouth and urinary retention from Umeclidinium, and tremors and palpitations from Vilanterol. Combining these medications can enhance treatment efficacy but necessitates careful monitoring for these side effects.

What prior FDA approvals exist?

The FDA has approved several combination inhalers for asthma treatment, including those containing Fluticasone Furoate and Vilanterol. These drugs, an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA), respectively, work together to reduce inflammation and open airways. Umeclidinium, a long-acting muscarinic antagonist (LAMA), is primarily approved for COPD but is being studied for asthma. The triple therapy inhaler combining Fluticasone Furoate, Umeclidinium, and Vilanterol represents a comprehensive treatment approach aimed at improving lung function and reducing asthma exacerbations.

What other types of research exist?

Promising novel alternatives to the Triple Therapy Inhaler for asthma patients include biological treatments such as mepolizumab, benralizumab, dupilumab, and omalizumab. These biologics target specific pathways involved in asthma inflammation and have shown efficacy in reducing exacerbations and improving lung function in patients with severe asthma.

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Corticosteroid, Long-acting muscarinic antagonist, Long-acting beta2-adrenergic agonist

Triple Therapy Inhaler for Asthma (ETHA Trial)

Phase 3

Waitlist Available

Led By Grace E Parraga, PhD

Research Sponsored by Dr. Grace Parraga

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has a history of poorly controlled asthma (i.e. ≥ 2 exacerbations in past 24 months)

Participant has documented treatment with a stable dose of low to medium dose inhaled corticosteroids (defined as >250 and ≤500 mcg fluticasone proprionate/day or equivalent or, >400 to ≤800 mcg Budesonide/day for at least 6 months prior to enrolment

Must not have

Participant is unable to perform spirometry maneuver

Participant is hospitalized or has had a major surgical procedure, major trauma requiring medical attention, or significant illness requiring medical attention within 4 weeks of Visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 to day 42

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial uses a combination of three medications to help adults with poorly controlled asthma. The medications work together to reduce lung inflammation and open airways, making it easier to breathe. One of the medications is being tested in combination with others to improve asthma control in patients who do not respond well to usual treatments.

Who is the study for?

Adults aged 18-70 with poorly controlled eosinophilic asthma, using long-acting β2-agonists for at least 6 months. Must not smoke or vape, have a history of less than one pack-year tobacco use, and no significant exacerbations in the last month. Women must use effective birth control and have a negative pregnancy test.

What is being tested?

The trial tests triple therapy inhaler (FF/UMEC/VI) effectiveness on asthma control by assessing lung function through MRI with xenon gas contrast, CT scans, spirometry, and questionnaires to measure air distribution in lungs compared to standard treatments.

What are the potential side effects?

Possible side effects include sore throat, hoarseness or voice changes (dysphonia), thrush in your mouth or throat (oral candidiasis), sinusitis, bronchitis and headache. More serious side effects can involve pneumonia in patients with COPD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had 2 or more asthma attacks in the last 2 years.

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I have been on a stable dose of certain asthma medications for at least 6 months.

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I am between 18 and 70 years old with a diagnosis of eosinophilic asthma.

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I have been using a long-acting asthma inhaler for at least 6 months.

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I haven't smoked or vaped for at least a year and have a smoking history of no more than 1 pack-year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot perform the breathing test required.

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I have not been hospitalized or had major surgery, trauma, or illness in the last 4 weeks.

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I am a new mother, within 8 weeks after giving birth or currently breastfeeding.

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I have a lung condition other than asthma or a disease that increases my eosinophil counts.

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I cannot hold my breath for an MRI.

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I am allergic to the medication used in this study.

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I am scheduled for surgery during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 to day 42

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 to day 42

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 42 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 Airway Function Measured Using 129-Xenon MRI Ventilation Defect Percent at the End of 6 Weeks of Treatment With FF/UMEC/VI 200/62.5/25ug Once Daily

Secondary study objectives

Change From Baseline Forced Expiration Volume in One Second

Change From Baseline Forced Vital Capacity

Change From Baseline Lung Clearance Index

+6 more

Side effects data

From 2019 Phase 4 trial • 3109 Patients • NCT03467425

Dyspnoea

Chronic obstructive pulmonary disease

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI

Non-Ellipta MITT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with poorly controlled moderate to severe asthmaExperimental Treatment1 Intervention

Participants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FF/UMEC/VI

2022

Completed Phase 4

~7120

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The triple therapy inhaler for asthma combines Fluticasone Furoate, Umeclidinium, and Vilanterol to provide comprehensive treatment. Fluticasone Furoate reduces lung inflammation, Umeclidinium opens airways by blocking muscarinic receptors, and Vilanterol relaxes airway smooth muscles. This combination is crucial for asthma patients as it addresses both inflammation and airway constriction, leading to better symptom control and improved lung function.

Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD.Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium/Vilanterol via a Single Inhaler in Patients with COPD.