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Dexpramipexole for Eosinophilic Asthma (EXHALE-4 Trial)

Verified Trial
Phase 3
Recruiting
Led By Mona Bafadhel, 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 physician diagnosis of asthma for ≥12 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline, pre-dose), weeks 4, 8, 12, 16, 20, and 24
Awards & highlights

EXHALE-4 Trial Summary

This trial studies if a drug can improve lung function, asthma control, and quality of life in people with eosinophilic asthma. It also looks at the drug's safety.

Who is the study for?
This trial is for adolescents and adults aged 12 or older with eosinophilic asthma that isn't well-controlled despite using daily low-dose inhaled corticosteroids and another maintenance medication. Participants should have a certain level of lung function reversibility after bronchodilator use, an eosinophil count within a specified range, and not be pregnant. Smokers or those with other complicating health issues are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of dexpramipexole dihydrochloride as an additional oral treatment to improve lung function, control asthma symptoms, and enhance quality of life in patients with eosinophilic asthma. It's compared against a placebo to assess improvements and side effects.See study design
What are the potential side effects?
While specific side effects for dexpramipexole in this context aren't detailed here, common ones may include digestive discomfort, potential blood disorders like neutropenia (low white blood cell count), liver enzyme changes, heart-related issues such as arrhythmias or QT interval changes on ECGs.

EXHALE-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with asthma for at least a year.

EXHALE-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (baseline, pre-dose), weeks 4, 8, 12, 16, 20, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline, pre-dose), weeks 4, 8, 12, 16, 20, and 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 in pre-BD FEV₁ from baseline
Secondary outcome measures
Change from baseline absolute eosinophil count (AEC) averaged across Weeks 20 and 24.
Change from baseline forced vital capacity (FVC) at Weeks 4, 8, 12, 16, 20, and 24.
Change from baseline forced vital capacity (FVC) averaged over Weeks 20 and 24.
+4 more

Side effects data

From 2017 Phase 4 trial • 52 Patients • NCT02033369
82%
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-4 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
2,325 Total Patients Enrolled
2 Trials studying Asthma
2,325 Patients Enrolled for Asthma
Mona Bafadhel, MDPrincipal InvestigatorGuy's and St Thomas' NHS Foundation Trust

Media Library

150 mg BID Clinical Trial Eligibility Overview. Trial Name: NCT05748600 — Phase 3
Asthma Research Study Groups: 150 mg BID, 75 mg BID, Placebo
Asthma Clinical Trial 2023: 150 mg BID Highlights & Side Effects. Trial Name: NCT05748600 — Phase 3
150 mg BID 2023 Treatment Timeline for Medical Study. Trial Name: NCT05748600 — Phase 3

Frequently Asked Questions

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

Is it safe to administer 150 milligrams twice daily for people?

"The safety of the 150 milligram twice-daily dose was rated a 3 due to evidence from Phase 3 trials demonstrating its efficacy and multiple rounds verifying its safety."

Answered by AI

Does the current research accommodate participants that are younger than 80 years old?

"The minimum age requirement to enroll in this trial is 12, while the maximum age cap is 99 years old."

Answered by AI

How many individuals have been recruited to participate in this experiment?

"750 individuals, who meet the designated qualifications for this trial, are necessary to complete it. These potential participants can be found at either Research Site 20001-048 in Aventura, Florida or Research Site 20001-051 in Brandon, Missouri."

Answered by AI

Who meets the eligibility criteria for this clinical research program?

"Prospective research participants should have eosinophilic asthma, be aged between 12 and 99 years old, and fill out the necessary paperwork to take part in this study. The trial has an estimated 750 enrollees."

Answered by AI

Are there any available spots in this current research project?

"Affirmative. Clinicaltrials.gov data confirms that this clinical experiment, originally posted on 1/30/2023, is actively recruiting patients to participate in the trial. The study requires 750 participants from 8 centers for enrollment."

Answered by AI

How many US-based sites are carrying out this investigation?

"Right now, 8 different trial sites are enrolling patients. These locales include Aventura, Brandon and Tampa alongside other areas. To minimize transportation demands, it is advisable to choose the closest site if you decide to join this experiment."

Answered by AI

Who else is applying?

What site did they apply to?
Tandem Clinical Research - New York, NY
Tandem Clinical Research - Houma, LA
Other
Tandem Clinical Research, Metairie
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

My medication doesn’t seem to help much. To help others first; to help me secondly.
PatientReceived no prior treatments
Find something better than ALBUTEROL ALBUTEROL. I have asthma problems bad but I have no car and no way to get out there and my health is not good enough to travel like that sorry.
PatientReceived 1 prior treatment
I am currently on Albuteral short term inhaler that sometimes work but I am also on the Symbicort long term inhaler when I run out I have to get another as soon as possible.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

So you pay travel and lodging and all expenses plus compensation?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Tandem Clinical Research - Houma, LA: < 24 hours
  2. Tandem Clinical Research, Metairie: < 24 hours
  3. ClinCloud - Viera, FL: < 48 hours
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma
2023. "A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05748600.
All > Frisco
~34 spots leftby Jun 2024
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