Your session is about to expire
← Back to Search
Dupilumab for Chronic Sinusitis
Study Summary
This trial is testing the effectiveness of a new drug for treating Chronic Rhinosinusitis, a condition characterized by inflammation of the sinuses. The study will exclude patients with nasal polyps, a common symptom of the disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 133 Patients • NCT04417894Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I haven't taken any biologic medication in the past 5 months or longer.My previous cancer has been in remission for at least 5 years.You have a CT score of 4 or more on both sides of your sinuses, or an endoscopy score of 4 or more.I agree to use contraception if I'm sexually active.I am not currently taking any excluded medications.I am not taking medications that affect dupilumab or lower eosinophils.You have a primary immune deficiency, including CVID.I currently have a fungal infection in my sinuses.I have had hepatitis B or C in the past.I have not been on immunosuppression, except for oral steroids, in the last 3 months.I am scheduled for sinus surgery.I have major issues with the structure of my nose.I have been diagnosed with primary ciliary dyskinesia.You have started treatment for allergies in the last three months.I have not received immunoglobulin or blood products in the last 30 days.You have a high blood eosinophil count or have tested positive for allergies to at least 5 out of 30 allergens, or you have a low blood eosinophil count and have tested negative for allergies (low Th2 group).I have not been treated for worm infections in the last 6 months.I have a known immunodeficiency disorder, including HIV.I have not received immunoglobulin or blood products in the last 30 days.I am not taking any immunosuppressive medications like methotrexate or cyclosporine.I may or may not have taken steroids or antibiotics before.I currently have a sinus infection.You have a SNOT-22 score of 30 or higher at the start of the study.My asthma is not well-managed.I have cystic fibrosis.You have had a severe allergic reaction to any biologic therapy or vaccine in the past.You have any other medical condition that would prevent you from participating in the study.I currently have a fever of 100.4°F or higher.I do not have serious heart or lung conditions that are not being treated.I take more than 81mg of aspirin daily.I am a woman over 50 and have not had a period for at least 12 months.I am between 18 and 75 years old and have chronic sinusitis without polyps.I have had nasal polyps in the last 3 years or they were seen in a recent CT scan or endoscopy.I haven't taken any anti-interleukin therapy in the last 5 months or longer.
- Group 1: dupilumab treatment group
- Group 2: placebo group
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Are there any precedents of dupilumab being administered in clinical trials?
"Currenty, 49 dupilumab trials are ongoing with 13 in the final stages of research. The largest concentration is located in Palo Alto, California but there are 2,602 total locations conducting studies for this medication."
How many participants are currently enrolled in this research project?
"Affirmative. Information hosted on clinicaltrials.gov confirms that this medical trial, which was first published on October 15th 2020, is actively seeking participants. Fifty patients are expected to be sourced from 1 centre."
Who is eligible to participate in this medical experiment?
"This medical trial is enrolling 50 people aged 18-75 years old with sinusitis. To be considered, they must meet the following criteria: Females over 50 who have been amenorrheic for 12 months or more since their last exogenous hormone treatment; SNOT-22 score of at least 30; bilateral Lund-Mackay CT score of 4 and/or MLK endoscopy rating of 4; blood eosinophil count higher than 300/ul and positive skin prick test to 5 out of 30 allergens, or an eosinophil count lower than 300/ul with negative SPT results"
What conditions is dupilumab employed in ameliorating?
"Dupilumab is primarily employed to treat atopic dermatitis, yet it can also assist with conditions such as corticosteroid-resistant asthma, eosinophilia and other related lung ailments."
Has the US Food and Drug Administration (FDA) granted approval for dupilumab?
"Dupilumab is rated a 2 on the safety scale due to existing evidence of its security, however there are currently no reports that confirm its efficacy."
Are individuals aged 25 and above being enlisted for this research?
"To be eligible to participate in this trial, potential enrollees must fall within the age range of 18 and 75. For those who do not meet these criteria, there are 21 trials for minors and 106 studies available for senior citizens."
Has the scientific community ever conducted a similar research endeavor?
"Currently, there are 49 ongoing studies related to dupilumab in 436 locations spanning 43 nations. The initial investigation of this medication was launched by Sanofi in 2015 and included 880 participants; it concluded Phase 3 clinical trials approval with positive results. Since then, 2739 additional experiments have been finalized."
Are there still opportunities to join this research endeavor?
"According to the clinicaltrials.gov data, this medical trial is currently recruiting participants. The research was first published on October 15th 2020 and most recently modified in October 12th 2022."
Share this study with friends
Copy Link
Messenger