Study 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.
- Nasal Polyps
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 6 Secondary · Reporting Duration: Week 56
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Benralizumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
276 Total Participants · 2 Treatment Groups
Primary Treatment: Benralizumab 30 mg · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 75 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3:CD013513. doi: 10.1002/14651858.CD013513.pub3.
- Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.
- 2019. "Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04157335.
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor