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Dupilumab for Nasal Polyps
Study Summary
This trial will test if dupilumab can reduce staph colonization and increase microbial diversity in people with sinus infections, correlating with improved smell and reduced inflammation.
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.Trial Design
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Who is running the clinical trial?
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- I am between 18 and 65 years old.My asthma is under control.I had a cold or similar illness in the last 6 weeks.I have taken oral corticosteroids in the last 60 days.I have a history of severe nasal polyps, including aspirin-exacerbated respiratory disease.I have not taken antibiotics in the last 6 weeks.You cannot participate if you are allergic to dupilumab or had a bad reaction to it before.If you have eczema, it should be well managed.I have been to urgent care, the ER, or hospitalized for asthma in the last 2 months.My doctor plans to treat me with dupilumab.I have been using nasal saline and topical corticosteroids for over a month.I have changed my sinus treatment within the last month.I have a serious health condition besides cancer.I've had sinus surgery that allows for easy sampling from my nose.I meet the criteria for using dupilumab for my nasal polyps.My asthma is not well-controlled.I am a current smoker or have smoked more than 10 pack-years.A test shows that you have staph aureus in your nose.I have not had biologic therapy, including for asthma, in the last 3 months.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
- Group 1: Dupilumab treatment
Frequently Asked Questions
Is the age threshold for this research restricted to individuals younger than 30?
"This research is open to those of legal age (above 18) and older than 65."
Does this research project still accept volunteers?
"Data on clinicaltrials.gov reveals that this clinical trial is still open to patient recruitment and has been since September 1st 2022, with the latest update being issued on March 6th 2023."
In what medical cases has Dupilumab shown to be a successful remedy?
"Dupilumab can be employed to address dermatitis, atopic conditions that have failed corticosteroid treatments, and eosinophilia."
Have any other clinical trials explored the effectiveness of Dupilumab?
"Currently, 47 studies are dedicated to Dupilumab treatment with 13 of them at the Phase 3 level. Town And Country in Missouri is one hub for these trials; however, 2719 sites throughout the world have availability for this medication."
What are the eligibility requirements to enroll in this medical trial?
"To be admitted to this trial, potential participants must have been diagnosed with nasal polyps and are between the ages of 18-65. A total of 20 individuals will be selected for the study."
How many participants have signed up for this research project?
"Affirmative. According to clinicaltrials.gov, this trial is actively accepting new participants since its commencement on September 1st 2022 and most recent edits made on March 6th 2023. The research team needs a total of 20 individuals at one medical centre for the study's completion."
Has a research project like this ever been attempted before?
"Since 2015, there have been 59 studies related to the effects of Dupilumab treatment. The first clinical trial was sponsored by Regeneron Pharmaceuticals and concluded its Phase 3 stage with 880 participants in total. Currently, 47 trials are underway across 463 cities and 42 nations worldwide."
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