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Benralizumab for Asthma (DOMINICA Trial)
DOMINICA Trial Summary
This trial tests a new treatment for severe asthma in children 6-18. It uses a new drug plus standard treatments to reduce asthma symptoms and attacks.
DOMINICA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDOMINICA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 3 trial • 220 Patients • NCT02075255DOMINICA Trial Design
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Who is running the clinical trial?
Media Library
- You are allergic to benralizumab or any of the ingredients in the medication.You have had a severe allergic reaction to any biologic medication in the past.I have had severe asthma attacks needing steroids or hospital visits.I can sign the consent form, and my caregiver can give consent for me.I am between 6 and 17 years old.I have severe asthma that could endanger my life.My asthma is linked to high eosinophil levels in my blood or lung tests.My lung function test shows reduced airflow.I have a lung condition that is not asthma, affecting my eosinophil counts.I have or had cancer.I haven't taken any experimental or approved biologic drugs recently.I have been diagnosed and treated for severe asthma for at least 6 months.I haven't needed steroids for asthma or had a serious respiratory infection in the last 2 weeks.I have been treated with benralizumab before.I use reliable birth control methods if I can have children and am sexually active.I have not received immunoglobulin or blood products in the last 30 days.I am currently taking medication that suppresses my immune system.You have taken at least 70% of your asthma medication as prescribed during the screening period.My body weight is at least 15 kg.I have a worm infection.I have been on a stable, high-dose asthma treatment plan for at least 6 months.I have been diagnosed with eosinophilic asthma for at least a year.Your asthma symptoms are not improving despite treatment.
- Group 1: Benralizumab
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
What risks are associated with the intake of Benralizumab?
"With a score of 3, Benralizumab has been evaluated to be safe as multiple rounds of research have supported the drug's efficacy and safety."
Is the demographic of potential participants restricted to those above a certain age?
"This clinical trial permits applicants aged between 6 and 18. Clinicialtrials.gov currently lists 116 trials for individuals under the age of 18, as well as 194 studies aimed at those over 65 years old."
Are there any vacancies for this experiment that prospective participants can fill?
"As per data on clinicaltrials.gov, this study is not currently accepting participants and the information has been recently updated as of January 11th 2023. For those still looking to participate in a medical trial, there are 315 other studies enrolling patients at present."
What types of individuals are the ideal candidates for this experiment?
"This clinical trial is enrolling 200 adolescent patients, aged 6 to 18 years old, who suffer from asthma. To be eligible for consideration, participants must demonstrate their ability to give assent and have a caregiver that can provide written informed consent prior to commencement of the study. In addition, candidates should have had eosinophilic airway inflammation related to asthma (demonstrated by peripheral blood eosinophil count of ≥ 300 cells/μL during screening OR a blood eosinophil count of 150 - 299 cells/μL and documentation of elevated eosinophils in bronchoalveolar lav"
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