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Dexpramipexole for Asthma (EXHALE-3 Trial)
Verified Trial
Phase 3
Recruiting
Led By Michael E. Wechsler, MD
Research Sponsored by Areteia Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female ≥12 years of age at randomization
Documented history of at least two asthma exacerbations requiring treatment with systemic corticosteroids within the past 12-month period prior to Screening Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1(baseline, pre-dose), weeks 4, 12, 20, 28, 36, 44, and 52.
Awards & highlights
EXHALE-3 Trial Summary
This trial tests a new drug to improve asthma symptoms in people with severe asthma not controlled by existing treatments.
Who is the study for?
This trial is for adolescents and adults over 12 years old with severe eosinophilic asthma that isn't well-controlled. They should have had at least two asthma attacks in the last year needing steroids, an eosinophil count above a certain level, and not be current smokers or have a heavy smoking history. Women who can get pregnant must use birth control.Check my eligibility
What is being tested?
The study tests dexpramipexole's safety and effectiveness against a placebo in managing severe eosinophilic asthma. Participants will randomly receive either the actual drug or a placebo to compare outcomes between the two groups.See study design
What are the potential side effects?
While specific side effects of dexpramipexole are not listed here, common ones may include headache, nausea, potential allergic reactions, or issues related to immune system changes due to its effect on white blood cells.
EXHALE-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEXHALE-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1(baseline, pre-dose), weeks 4, 12, 20, 28, 36, 44, and 52.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1(baseline, pre-dose), weeks 4, 12, 20, 28, 36, 44, and 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 FEV₁) from Baseline
Annualized rate of severe exacerbations (AAER) from Week 4 to Week 52.
Annualized rate of severe exacerbations requiring an emergency over 52 weeks department visit or hospitalization
+9 moreSide effects data
From 2017 Phase 4 trial • 52 Patients • NCT0203336982%
nausea
59%
headache
50%
somnolence
45%
Lightheadedness
45%
Dry Mouth
41%
Insomnia
41%
Restlessness
36%
Dizziness
32%
Forgetfulness
32%
Vomiting
32%
Heartburn
32%
decreased libido
27%
Blurry Vision
27%
Decreased Appetite
27%
Increased Appetite
23%
Diarrhea
23%
Sleep Attacks
23%
Skin Problems
18%
Constipation
18%
Sweating
18%
Impaired Coordination
14%
Sexual Dysfunction
14%
compulsive behaviorws
9%
Bruising
9%
tremor
9%
Impaired Concentration
9%
fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
MDD Patients
EXHALE-3 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
1,945 Total Patients Enrolled
2 Trials studying Asthma
1,945 Patients Enrolled for Asthma
Michael E. Wechsler, MDPrincipal InvestigatorNational Jewish Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a severe asthma attack within 4 weeks before my first screening visit up to now.You have smoked within the past year or have a history of smoking more than 10 packs of cigarettes.I have very high blood pressure that isn't controlled by medication.I've needed steroids for asthma attacks at least twice in the last year.I had cancer treatment within the last 5 years.You cannot take certain medicines or undergo certain medical procedures while participating in the study.You have evidence of variable airflow obstruction through one or more methodologies.My heart is healthy enough for treatment.You have a history of not following your medication schedule as directed.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 this coming year.I do not have any health conditions that could affect this study's results.Your pre-BD FEV₁ is between 40% and 80% of the predicted value at Screening Visit 2.You are pregnant or currently breastfeeding.I am 12 years old or older.You have a history of alcohol or drug abuse or are currently experiencing substance addiction.
Research Study Groups:
This trial has the following groups:- Group 1: 150 mg BID
- Group 2: 75 mg BID
- Group 3: Placebo
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.
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 it possible to join this investigation as a participant?
"Those with asthma and aged between 12 to 99 can qualify for the trial, which is seeking a total of 930 participants."
Answered by AI
Is recruitment currently underway for this particular clinical trial?
"Clinicaltrials.gov confirms that presently, the medical trial is accepting patients to participate. The research was first published on March 27th of 2021 and has since been updated for accuracy on April 13th of this year."
Answered by AI
Does the eligibility for this research extend to those over 25 years old?
"This research project is open to patients aged 12 to 99, with separate studies totaling 133 and 210 for younger and older cohorts respectively."
Answered by AI
Is a dosage of 150 milligrams administered twice daily safe for patients?
"The safety profile of administering 150 mg BID was rated as a 3 due to the presence of clinical trials illustrating its efficacy and multiple studies demonstrating its security."
Answered by AI
What is the aggregate amount of participants in this clinical research?
"Affirmative. According to clinicaltrials.gov, this research study is actively seeking out participants and was first posted on March 27th 2023 with the latest edit occurring on April 13th 2023. The trial aims to recruit 930 patients from a single site.."
Answered by AI
Who else is applying?
What site did they apply to?
Other
Tandem Clinical Research - Metairie, LA
ClinCloud, Viera
ClinCloud, Maitland
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
I don't have asthma. I want to be contacted about other trials. I have had asthma my whole life and it is completely out of control.
PatientReceived 1 prior treatment
My Asthma is getting worse and it takes more albeurotal with each attack to get it under control..
PatientReceived no prior treatments
After having COVID for the fourth time, and pneumonia for the second time (in Nov./Dec. 2023), I my fatigue and asthma symptoms have intensified. I have tried a few different inhalers, as well as been on oral steroids, but have not improved.
PatientReceived 2+ prior treatments
I've had asthma since I was little and as I got older it obviously progressed. My mom died of cold and ling cancer is in our family. I've always tried to keep it under control, I've been told to do breathing techniques and learn to breath as I do different things like running and working out and things like that. I am very active and I am always afraid I'm going to have an asthma attack and that scares the **** out of me and keeps me from doing alot more things I would like to do I. My life. I may not be able to get rid of my asthma but I can control it and prevent it from stopping g me to live a normal life.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do screening visits take?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- ClinCloud, Viera: < 24 hours
- ClinCloud, Maitland: < 24 hours
- Tandem Clinical Research - Houma, LA: < 24 hours
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