Dexpramipexole for Asthma
(EXHALE-3 Trial)
Recruiting at25 trial locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Areteia Therapeutics
Must be taking: Inhaled corticosteroids
Must not be taking: Monoclonal antibodies, Pramipexole
Disqualifiers: Severe asthma exacerbation, Respiratory infection, Smoking, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a medication called dexpramipexole to see if it can help people with severe eosinophilic asthma that isn't well-controlled by current treatments. The medication works by lowering the levels of certain cells in the blood that cause inflammation. The goal is to find out if this can improve asthma symptoms and be safe for patients.
Will I have to stop taking my current medications?
The trial does not specify that you need to stop taking your current asthma medications. In fact, it requires that you continue using your current asthma controller medications at a stable dose. However, certain medications like pramipexole and specific monoclonal antibody therapies must be stopped before the trial.
Research Team
ME
Michael Wechsler
Principal Investigator
National Jewish Health
Eligibility Criteria
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.Inclusion Criteria
Documented history of at least two asthma exacerbations requiring treatment with systemic corticosteroids within the past 12-month period prior to Screening Visit 1
Male or female ≥12 years of age at randomization
You have evidence of variable airflow obstruction through one or more methodologies.
See 1 more
Exclusion Criteria
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 have had a severe asthma attack within 4 weeks before my first screening visit up to now.
See 9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive dexpramipexole or placebo orally twice a day for 52 weeks
52 weeks
Regular visits throughout the 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Dexpramipexole Dihydrochloride (Other)
- Placebo (Drug)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You
Who Is Running the Clinical Trial?
Areteia Therapeutics
Lead Sponsor
Trials
5
Recruited
4,500+
Findings from Research
RP 49356 is a novel potassium channel opener that effectively relaxes airway smooth muscle in vitro, similar to another compound, cromakalim, and works by opening sulphonylurea-sensitive K+ channels.
The compound shows greater potency in relaxing airway tissues that are already contracted (spasmolytic effects) rather than preventing contraction from spasmogens, indicating its potential use in treating conditions with airway constriction.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
RP 49356 and cromakalim relax airway smooth muscle in vitro by opening a sulphonylurea-sensitive K+ channel: a comparison with nifedipine.Raeburn, D., Brown, TJ.[2014]
In a study involving 23 patients with nocturnal asthma, a single dose of 0.5 mg cromakalim significantly reduced the early morning drop in lung function (FEV1) compared to placebo, indicating its potential efficacy in managing nocturnal asthma symptoms.
In a follow-up study with 8 asthmatic subjects, repeated doses of cromakalim (0.25 mg and 0.5 mg) over 5 nights further decreased the early morning FEV1 decline, suggesting that potassium-channel activators could be beneficial for long-term asthma management, particularly for nighttime symptoms.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Attenuation of nocturnal asthma by cromakalim.Williams, AJ., Lee, TH., Cochrane, GM., et al.[2019]
In a study involving eight mild asthmatic subjects, both nedocromil sodium and sodium cromoglycate significantly protected against bradykinin-induced bronchoconstriction, indicating their potential efficacy in managing asthma symptoms.
The study suggests that these medications may act on neural pathways involved in bronchoconstriction, providing insight into their mechanism of action in asthma control.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Bradykinin-induced bronchoconstriction: inhibition by nedocromil sodium and sodium cromoglycate.Dixon, CM., Barnes, PJ.[2019]
References
RP 49356 and cromakalim relax airway smooth muscle in vitro by opening a sulphonylurea-sensitive K+ channel: a comparison with nifedipine. [2014]
Attenuation of nocturnal asthma by cromakalim. [2019]
Bradykinin-induced bronchoconstriction: inhibition by nedocromil sodium and sodium cromoglycate. [2019]
The lack of bronchodilator effect and the short-term safety of cumulative single doses of an inhaled potassium channel opener (bimakalim) in adult patients with mild to moderate bronchial asthma. [2019]
The action of a potassium channel activator, BRL 38227 (lemakalim), on human airway smooth muscle. [2014]