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Dexpramipexole for Asthma (EXHALE-2 Trial)
Phase 3
Recruiting
Led By Salman Siddiqui, MD
Research Sponsored by Areteia Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented history of at least two asthma exacerbations requiring treatment with systemic corticosteroids within the past 12-month period prior to Screening Visit 1
Pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) ≥40% and <80% (<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline, pre-dose), weeks 4, 12, 20,28 36, 44, 52
Awards & highlights
EXHALE-2 Trial Summary
This trial tests a medication for asthma, to see if it helps control symptoms in those with severe asthma and a history of flare-ups.
Who is the study for?
This trial is for adolescents and adults aged 12 or older with severe eosinophilic asthma that isn't well-controlled, despite current treatments. Participants must have had at least two asthma attacks in the past year requiring steroids. Women who can have children must use effective birth control.Check my eligibility
What is being tested?
The study tests Dexpramipexole as an additional oral treatment against a placebo to see if it helps people with a specific type of severe asthma. The goal is to find out if this new medicine can reduce asthma symptoms and prevent attacks.See study design
What are the potential side effects?
While the potential side effects of Dexpramipexole are not detailed here, common side effects may include headache, dizziness, gastrointestinal issues, or allergic reactions. Placebo pills typically do not cause side effects but mimic those of the tested drug due to psychological factors.
EXHALE-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've needed steroids for asthma attacks at least twice in the last year.
Select...
My lung function is between 40% and 80% of the expected value.
Select...
I am being treated for asthma with specific medications.
EXHALE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (baseline, pre-dose), weeks 4, 12, 20,28 36, 44, 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (baseline, pre-dose), weeks 4, 12, 20,28 36, 44, 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized rate of severe asthma exacerbations over 52 weeks.
Secondary outcome measures
Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV)₁ from Baseline
Annualized Rate of severe exacerbations from Week 4 to Week 52
Annualized rate of severe exacerbations requiring an emergency department visit or hospitalization over 52 weeks.
+10 moreEXHALE-2 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 75 mg BIDExperimental Treatment1 Intervention
Dexpramipexole 75 mg oral tablet taken twice a day
Group II: 150 mg BIDExperimental Treatment1 Intervention
Dexpramipexole 150 mg oral tablet taken twice a day
Group III: PlaceboPlacebo Group1 Intervention
Placebo oral tablet taken twice a day
Find a Location
Who is running the clinical trial?
Areteia TherapeuticsLead Sponsor
2 Previous Clinical Trials
1,480 Total Patients Enrolled
2 Trials studying Asthma
1,480 Patients Enrolled for Asthma
Salman Siddiqui, MDPrincipal InvestigatorImperial College Healthcare NHS Trust (via Imperial Consultants)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've needed steroids for asthma attacks at least twice in the last year.I have not taken any medications or undergone procedures that are not allowed in this trial.I have been diagnosed with asthma for at least a year.My lung function is between 40% and 80% of the expected value.My white blood cell count is low.I am 12 years old or older.I am not pregnant, breastfeeding, and if male, I agree to use birth control.Your ACQ-6 score is 1.5 or higher during the second screening visit.I am being treated for asthma with specific medications.I am using reliable birth control methods if I can become pregnant.I have not had a respiratory infection in the last 4 weeks.I have not had a bronchial thermoplasty in the last year nor plan to have one.You have a specific type of breathing problem that has been confirmed with certain tests.I have had a severe asthma attack in the last 4 weeks.I do not have any health conditions that could affect the study's results.My blood, kidney, and liver tests are within safe ranges.I do not have a history of serious heart conditions.Women who can have babies must have a negative pregnancy test before the study starts.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: 150 mg BID
- Group 3: 75 mg BID
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 25 and over eligible to participate in this trial?
"The minimum age of entry for this trial is 12, while the upper age limit is set at 99 years old."
Answered by AI
Does the FDA recognize 150 mg administered twice daily as an approved dosage?
"Due to the abundance of evidence in support of efficacy and safety as seen during Phase 3 trials, our team has assigned a rating of 3 out of 3 for 150 mg BID."
Answered by AI
How many sites are hosting this clinical trial?
"The 8 different trial locations include sites in Aventura, Brandon and Hialeah. Other research centres are also participating across the United States of America."
Answered by AI
Does my profile match the criteria for enrollment in this clinical experiment?
"To partake in this trial, the participant must have eosinophilic asthma and they must be between 12 to 99 years old. The overall patient goal is 1395 individuals."
Answered by AI
Are new participants currently being accepted into this investigation?
"Correct. According to information hosted on clinicaltrials.gov, this clinical trial is presently in search of participants. It was initially published on January 30th 2023 and the most recent update occurred March 1st 2023. 1395 people are needed from 8 separate sites for enrollment into this study."
Answered by AI
What is the scope of enrollment for this clinical investigation?
"To successfully complete this medical study, 1395 volunteers that qualify for inclusion must take part. These participants can enroll in the trial from Research Site 20001-048 located in Aventura, Florida and Research Site 20001-051 found in Brandon, Missouri."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Research Site 20001-003
Research Site 20001-034
Research Site 20001-038
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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