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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 42
Awards & highlights
ETHA Trial Summary
This trial will evaluate how effective a triple therapy inhaler is in treating asthma, using MRI, CT, lung function tests & questionnaires.
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.Check my eligibility
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.See study design
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.
ETHA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I am between 18 and 70 years old with a diagnosis of eosinophilic asthma.
Select...
I have been using a long-acting asthma inhaler for at least 6 months.
Select...
I haven't smoked or vaped for at least a year and have a smoking history of no more than 1 pack-year.
ETHA Trial 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
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 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 outcome measures
Change From Baseline Forced Expiration Volume in One Second
Change From Baseline Forced Vital Capacity
Change From Baseline Lung Clearance Index
+6 moreSide effects data
From 2019 Phase 4 trial • 3109 Patients • NCT034674252%
Chronic obstructive pulmonary disease
2%
Dyspnoea
2%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI
Non-Ellipta MITT
ETHA 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
~6890
Find a Location
Who is running the clinical trial?
Dr. Grace ParragaLead Sponsor
5 Previous Clinical Trials
454 Total Patients Enrolled
4 Trials studying Asthma
254 Patients Enrolled for Asthma
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,422 Total Patients Enrolled
294 Trials studying Asthma
415,396 Patients Enrolled for Asthma
Grace E Parraga, PhDPrincipal InvestigatorRobarts Research Institute, The University of Western Ontario
14 Previous Clinical Trials
1,333 Total Patients Enrolled
4 Trials studying Asthma
254 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ACQ-6 score is 1.5 or higher at the first visit.I cannot perform the breathing test required.You have participated in a study for a specific medication called FF/UMEC/VI 200/62.5/25ug before.I have had 2 or more asthma attacks in the last 2 years.I have not been hospitalized or had major surgery, trauma, or illness in the last 4 weeks.I have been on a stable dose of certain asthma medications for at least 6 months.I am a new mother, within 8 weeks after giving birth or currently breastfeeding.I am using a reliable form of birth control.My blood eosinophil count is 200 or more, or my FENO level is 25 or higher.I haven't needed antibiotics or antivirals for a respiratory infection in the last 30 days.I haven't had a major asthma attack or needed more steroids in the last 30 days.I have not received immunoglobulin or blood products in the last 30 days.I agree to use double barrier contraception during and 8 weeks after the study.I have a lung condition other than asthma or a disease that increases my eosinophil counts.You have any health issues that the doctor thinks could affect your safety during the study, affect the study results, or make it hard for you to finish the study.I am between 18 and 70 years old with a diagnosis of eosinophilic asthma.I have not received any live vaccines in the last 30 days.I have been using a long-acting asthma inhaler for at least 6 months.You have a device or metal in your body that can't be taken out, like a pacemaker or surgical staples.I cannot hold my breath for an MRI.Your blood pressure is consistently higher than 150/95 mmHg during the screening visit.I am allergic to the medication used in this study.I haven't smoked or vaped for at least a year and have a smoking history of no more than 1 pack-year.I am scheduled for surgery during the study.You have had problems with drinking too much alcohol or using drugs in the past year.I am able to understand and consent to my own medical treatment.Your FEV1 (a measure of lung function) is between 35% and 80% of what is expected for someone your age, height, and gender.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with poorly controlled moderate to severe asthma
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research open to elderly individuals?
"Participants who will be incorporated into this research must have attained majority status and not yet reached their seventieth birthday."
Answered by AI
What risks do individuals with poorly-managed moderate to severe asthma pose?
"The safety of individuals with poorly managed moderate to severe asthma was rated a 3, as Phase 3 clinical trials have evidenced efficacy and demonstrated multiple rounds of data confirming its security."
Answered by AI
Who is eligible for participation in this clinical research?
"Individuals between the ages of 18 and 70 who have been diagnosed with asthma are eligible to participate in this trial. Approximately 30 people will be admitted as participants."
Answered by AI
To what extent is this trial limited in terms of participant size?
"Affirmative. The information available on clinicaltrials.gov confirms that the trial, which was initially posted on August 8th 2022, is currently recruiting participants. 30 patients are needed to join this single-site study."
Answered by AI
Does this trial have any current openings for participants?
"Affirmative. The information available on clinicaltrials.gov implies that this clinical trial is currently searching for volunteers, with the original post dated 8/8/2022 and most recent update being 5/10/2023. 30 participants are required at 1 medical centre to complete the study objectives."
Answered by AI
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