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150 mg BID for Asthma (EXHALE-5 Trial)

Phase 3

Waitlist Available

Led By Sady Alpizar, MD

Research Sponsored by Areteia Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (baseline), weeks 16, 32, and 52

Awards & highlights

EXHALE-5 Trial Summary

This trial aims to study the safety of using dexpramipexole in the long term for individuals aged 12 years and older with severe asthma who are already on certain asthma treatments.

Who is the study for?

This trial is for people aged 12 or older with severe asthma who are already on high-level asthma treatments (GINA Step 4 or 5) and have completed the EXHALE-2 or EXHALE-3 studies. It's not specified who can't join, but typically there would be criteria to exclude those with other health issues that could affect results.Check my eligibility

What is being tested?

The study tests the long-term safety of a drug called Dexpramipexole Dihydrochloride in individuals with severe asthma. Participants from previous Phase III trials will continue treatment to gather more data on its effects over an extended period.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally, drugs like Dexpramipexole may cause reactions at the site of administration, headaches, gastrointestinal discomforts such as nausea or diarrhea, and potential respiratory symptoms.

EXHALE-5 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (baseline), weeks 16, 32, and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (baseline), weeks 16, 32, and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline), weeks 16, 32, and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations

Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight

Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters

+1 more

Secondary outcome measures

Change in Asthma Control Questionnaire-6 (ACQ-6)

Change in absolute eosinophil counts (AEC)

Severe Asthma Exacerbations

EXHALE-5 Trial Design

1Treatment groups

Experimental Treatment

Group I: 150 mg BIDExperimental Treatment1 Intervention

Dexpramipexole 150 mg oral tablet taken twice a day.

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Who is running the clinical trial?

Areteia TherapeuticsLead Sponsor

3 Previous Clinical Trials

2,875 Total Patients Enrolled

3 Trials studying Asthma

2,875 Patients Enrolled for Asthma

Sady Alpizar, MDPrincipal InvestigatorClinical Research Trials of Florida, Inc.

Frequently Asked Questions

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

Which specific criteria determine the eligibility of individuals to participate in this research endeavor?

"Individuals aged between 12 to 99 years old diagnosed with asthma are eligible for recruitment in this research study, which aims to enroll a total of 1600 participants."

Answered by AI

Is there an ongoing enrollment process for participants in this medical study?

"As per clinicaltrials.gov, the current status of this investigation indicates that participant enrollment is not ongoing. The trial's initial posting date was noted as 5th August 2024, with the most recent update recorded on 24th April 2024. Although recruitment for this specific study is closed at present, it is noteworthy that there are currently 326 alternative trials actively seeking participants."

Answered by AI

Are participants younger than 50 years of age eligible for enrollment in this clinical trial?

"Recruitment for this research project is targeted towards individuals aged 12 years and older, up to a maximum age of 99 years."

Answered by AI

What risks are associated with a dosage of 150 mg administered twice daily for patients?

"Our team at Power has assessed the safety of administering 150 mg BID to be a level 3 on our scale. This rating is informed by the trial being in Phase 3, indicating existing efficacy data and robust safety profiles gathered over multiple evaluations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase III Long-Term Extension Study With Dexpramipexole

2024. "Phase III Long-Term Extension Study With Dexpramipexole". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06388889.