What side effects are associated with this type of intervention?

Common treatments for asthma, particularly those targeting eosinophilic asthma, include inhaled glucocorticoids, LABAs, LAMAs, and biologics like mepolizumab and omalizumab. Inhaled glucocorticoids can cause oral thrush and hoarseness. LABAs may lead to tremors and palpitations. LAMAs, such as tiotropium, can cause dry mouth and urinary retention. Biologics like mepolizumab and omalizumab are generally well-tolerated but can cause injection site reactions and, rarely, anaphylaxis.

What prior FDA approvals exist?

Several FDA-approved treatments target eosinophilic asthma by reducing eosinophil levels. Mepolizumab, an anti-IL-5 monoclonal antibody, has been approved for severe eosinophilic asthma and has shown efficacy in reducing asthma exacerbations and improving quality of life. Benralizumab, another anti-IL-5 receptor monoclonal antibody, depletes eosinophils and is approved for severe eosinophilic asthma. Dupilumab, an IL-4 receptor alpha antagonist, is also approved for moderate-to-severe asthma with an eosinophilic phenotype. These treatments are similar to dexpramipexole, which is being studied for its potential to reduce eosinophil levels in eosinophilic asthma.

What other types of research exist?

Promising novel alternatives to dexpramipexole for reducing eosinophil levels in asthma patients include benralizumab, an IL-5 receptor antagonist, and omalizumab, an anti-IgE antibody. Both have shown efficacy in managing severe eosinophilic asthma.

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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

Pivotal Trial

Summary

This trial is testing an oral medication called dexpramipexole to help people with a type of asthma that isn't well controlled by their current treatments. The medication works by reducing specific white blood cells that cause inflammation, which may improve breathing and asthma control.

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (baseline, pre-dose), weeks 4, 8, 12, 16, 20, and 24

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pre-BD FEV₁ from baseline

Secondary study objectives

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

Bruising

tremor

Impaired Concentration

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

MDD Patients

Awards & Highlights

Pivotal Trial

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

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

0 / 1Eligibility 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

Asthma treatments often target the underlying inflammation and bronchoconstriction that characterize the disease. Eosinophils, a type of white blood cell, play a significant role in the inflammation seen in eosinophilic asthma. Dexpramipexole, an investigational drug, aims to reduce eosinophil levels, thereby decreasing inflammation and improving lung function. Other common treatments include inhaled corticosteroids (ICS) that reduce overall airway inflammation, long-acting beta-agonists (LABAs) that relax bronchial muscles to improve airflow, and leukotriene receptor antagonists like montelukast that block inflammatory pathways. These treatments are crucial for asthma patients as they help control symptoms, prevent exacerbations, and improve quality of life.

Mepolizumab versus placebo for asthma.