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Benralizumab for Nasal Polyps (ORCHID Trial)
ORCHID Trial Summary
This trial is testing whether the drug benralizumab can help treat patients with severe nasal polyposis. The trial is double-blind, meaning that neither the patients nor the researchers will know who is receiving the drug and who is receiving the placebo. The trial is international, meaning it will be conducted in multiple countries.
ORCHID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowORCHID Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ORCHID Trial Design
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Who is running the clinical trial?
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- I do not have conditions like severe nasal blockage or specific sinus issues that would prevent accurate assessment of the treatment's effectiveness.I haven't taken any experimental or approved biologic drugs in the last 6 months.Your SNOT-22 score is 20 or higher when you join the study.I have been diagnosed with asthma by a doctor.I have had symptoms for at least 3 months before joining.I have been using nasal sprays for allergies consistently for the last 4 weeks.I have severe nasal polyps in both nostrils.Your blood test shows a high level of eosinophils.Your blood test shows a high level of eosinophils.Your SNOT-22 score is 20 or higher when you join the study.I have severe nasal polyps in both nostrils.I have been using nasal sprays for allergies consistently for the last 4 weeks.I often have a blocked nose that bothers me.I have received spinal cord stimulation within the last 4 weeks or have it scheduled.I have not had nasal or sinus surgery in the last 3 months.I have had surgery or been treated with steroids for nasal polyps.Your average blood sugar level is consistently high every two weeks.Your blood sugar levels are consistently high every two weeks.I often have a blocked nose that bothers me.I am between 18 and 75 years old.You have other health conditions that could make it risky for you to participate in the study, or could make it hard to understand the results of the study.
- 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
Does this research project exclude elderly patients?
"Eligibility requirements for this particular clinical trial state that potential patients must be between 18-75 years old. There are alternative medical trials available for those outside of this age range: 6 for children and 62 for adults over 65."
What sets this research apart from other similar investigations?
"Benralizumab 30 mg is being trialed in 20 different ongoing studies across 352 cities and 42 countries. The first study was completed in 2014 and involved 20 patients. 43 studies have been completed in total."
Does Benralizumab 30 mg have any negative side effects?
"Given that this is a Phase 3 trial with both efficacy and safety data, Benralizumab 30 mg was rated a 3 for safety by our team at Power."
Are there any other ongoing research projects using Benralizumab at a dose of 30 mg?
"Benralizumab 30 mg was first trialed in 2014 at National Institutes of Health Clinical Center. As of now, 43 studies have been completed with 20 more underway. Of these 20, a considerable amount are taking place in Boston, Massachusetts."
What treatments or techniques are being tested in this clinical trial?
"The primary outcome metric for this study, which will be assessed over a Baseline and week 56 time frame is Nasal Polyp Burden. However, Secondary outcomes include Sense of Smell ( Change from baseline in difficulty with sense of smell [DSS] score), Sinus Opacification by CT Scan (Change from baseline in Lund Mackay score), and Disease specific health-related quality of life (HRQoL) (Change from baseline in SinoNasal Outcome Test [SNOT-22] score)."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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