Effects of dupilumab on chronic rhinosinusitis with nasal polyps in diverse patients
Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
This study is testing if dupilumab can help people with chronic rhinosinusitis and nasal polyps feel better and improve their sense of smell, especially in diverse groups, while also looking at its effects on asthma symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | Dupilumab, prednisone |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05246267 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of dupilumab, a biologic medication, in treating chronic rhinosinusitis with nasal polyps (CRSwNP) among a diverse population, particularly focusing on ethnic and racial minorities. It aims to confirm the drug's efficacy in improving disease activity and sense of smell, while also establishing biomarkers for therapeutic response. Additionally, the study will assess the impact of dupilumab on asthma symptoms and lung function in patients with comorbid asthma. Participants will undergo a series of visits for screening, baseline treatment, and follow-ups over a year.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with physician-diagnosed CRSwNP, with or without asthma, who meet the criteria for dupilumab treatment.
Not a fit: Patients with conditions such as allergic fungal rhinosinusitis, cystic fibrosis, or those who have had recent biologic treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with CRSwNP, particularly those from underrepresented ethnic backgrounds.
How similar studies have performed: While dupilumab has shown promise in treating CRSwNP, this specific focus on an ethnically diverse population is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab. * Patients aged 18 years and older. * Patient willing to provide consent to be a participant in the study. * Patients with insurance that allows Dupilumab coverage or Dupilumab coverage obtained through "Dupixent MyWay Program" Exclusion Criteria: * Age under 18 * Suspected or diagnosed allergic fungal rhinosinusitis. * Suspected or diagnosed cystic fibrosis. * Dupilumab coverage denied through insurance or "Dupixent MyWay Program" * Patients who required a steroid taper in the preceding 30 days. However, patients on chronic steroids less or equal to 20 mg of prednisone daily, are eligible. * Patients who were on a different biologic medication in the preceding 3 months. * Patients with a diagnosis of EGPA/Churg-Strauss Syndrome * Pregnant patients * Patients with inverted papilloma growth
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Golda Hudes, MD — Montefiore Medical Center
- Study coordinator: Golda Hudes, MD
- Email: ghudes@montefiore.org
- Phone: 866-633-8255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.