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New treatment option for Nasal Polyps
Official title Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
ClinicalTrials.gov ID: NCT05094570
What this study is testing
What is Dupilumab Prefilled Syringe?
Dupilumab Prefilled Syringe is an investigational medicine, being studied as a potential treatment for nasal polyps.
Also referred to as DUPIXENT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Hypothesis: The investigators hypothesize that in patients with CRSwNP who demonstrate sinus colonization with staphylococcus aureus, the administration of dupilumab will be associated with decreased staph colonization and an increase in microbial diversity. Primary Objective will be to demonstrate that dupilumab reduces staphylococcus aureus (phyla firmicutes) abundance while increasing microbial diversity in patients with CRSwNPs who are culture positive for staph aureus at enrollment.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adults, ages 18-65
- History of CRSwNP including people with AERD
- Sinonasal culture demonstrating staph aureus at visit 1
- History of FESS with patent sinus ostia sufficient to obtain culture and tissue samples from the middle meatus
- Asthma, if present, should be well controlled
You likely can't join if
- Concurrent serious medical problem
- Uncontrolled asthma (ACT \<20 at screening visit)
- Recent (within 60 days) use of oral corticosteroids
- Recent (within 60 days) urgent care, ED visit, or hospitalization for asthma
- Current smoker or has smoked \>10 pack-years
- Biologic therapy including asthma biologic therapy in last 3 months
See the full eligibility criteria
- Adults, ages 18-65
- History of CRSwNP including people with AERD
- Sinonasal culture demonstrating staph aureus at visit 1
- History of FESS with patent sinus ostia sufficient to obtain culture and tissue samples from the middle meatus
- Asthma, if present, should be well controlled
- Atopic dermatitis, if present, should be well controlled
- Use of nasal saline irrigation and stable dosing (\>1 month) of topical corticosteroids is permitted
- Intent of the physicians caring to start dupilumab therapy as part of subject's standard of care
- Subject meets FDA approved criteria for the use of dupilumab for nasal polyps
- Concurrent serious medical problem
- Uncontrolled asthma (ACT \<20 at screening visit)
- Recent (within 60 days) use of oral corticosteroids
- Recent (within 60 days) urgent care, ED visit, or hospitalization for asthma
- Current smoker or has smoked \>10 pack-years
- Biologic therapy including asthma biologic therapy in last 3 months
- Recent (within 1 month) change in CRS medical treatment (topical steroids, surfactants, irrigation protocol, etc. including changes in delivery volume or delivery methodology)
- Recent (within 6 weeks) upper respiratory infection
- Antibiotics within 6 weeks
- Pregnant or breast-feeding women
- Any contraindication to the use of dupilumab including hypersensitivity on previous administration
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.