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Dexpramipexole for Asthma (EXHALE-2 Trial)
EXHALE-2 Trial Summary
This trial tests a medication for asthma, to see if it helps control symptoms in those with severe asthma and a history of flare-ups.
EXHALE-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEXHALE-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EXHALE-2 Trial Design
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Who is running the clinical trial?
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- I've needed steroids for asthma attacks at least twice in the last year.I have not taken any medications or undergone procedures that are not allowed in this trial.I have been diagnosed with asthma for at least a year.My lung function is between 40% and 80% of the expected value.My white blood cell count is low.I am 12 years old or older.I am not pregnant, breastfeeding, and if male, I agree to use birth control.Your ACQ-6 score is 1.5 or higher during the second screening visit.I am being treated for asthma with specific medications.I am using reliable birth control methods if I can become pregnant.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.You have a specific type of breathing problem that has been confirmed with certain tests.I have had a severe asthma attack in the last 4 weeks.I do not have any health conditions that could affect the study's results.My blood, kidney, and liver tests are within safe ranges.I do not have a history of serious heart conditions.Women who can have babies must have a negative pregnancy test before the study starts.
- 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.
- Group 1: Placebo
- Group 2: 150 mg BID
- Group 3: 75 mg BID
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
Are individuals aged 25 and over eligible to participate in this trial?
"The minimum age of entry for this trial is 12, while the upper age limit is set at 99 years old."
Does the FDA recognize 150 mg administered twice daily as an approved dosage?
"Due to the abundance of evidence in support of efficacy and safety as seen during Phase 3 trials, our team has assigned a rating of 3 out of 3 for 150 mg BID."
How many sites are hosting this clinical trial?
"The 8 different trial locations include sites in Aventura, Brandon and Hialeah. Other research centres are also participating across the United States of America."
Does my profile match the criteria for enrollment in this clinical experiment?
"To partake in this trial, the participant must have eosinophilic asthma and they must be between 12 to 99 years old. The overall patient goal is 1395 individuals."
Are new participants currently being accepted into this investigation?
"Correct. According to information hosted on clinicaltrials.gov, this clinical trial is presently in search of participants. It was initially published on January 30th 2023 and the most recent update occurred March 1st 2023. 1395 people are needed from 8 separate sites for enrollment into this study."
What is the scope of enrollment for this clinical investigation?
"To successfully complete this medical study, 1395 volunteers that qualify for inclusion must take part. These participants can enroll in the trial from Research Site 20001-048 located in Aventura, Florida and Research Site 20001-051 found in Brandon, Missouri."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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