Status:
NOT_YET_RECRUITING
Immunologic Impact of Dupilumab in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps
Lead Sponsor:
Dr. Andrew Thamboo, MD
Collaborating Sponsors:
Sanofi
Conditions:
Chronic Rhinosinusitis With Nasal Polyps
Asthma
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The investigators are studying adults who have chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate to severe asthma, and who are undergoing Endoscopic Sinus Surgery (ESS). Investigators wan...
Detailed Description
In adult patients with CRSwNP with concomitant moderate-severe asthma undergoing Endoscopic Sinus Surgery (ESS), what is the change in the inflammatory cascade in the upper and lower airways from pati...
Eligibility Criteria
Inclusion
- Patients over the age of 19.
- Patients undergoing Endoscopic Sinus Surgery (ESS)
- Patients with CRSwNP with moderate-severe asthma according to 2020 EPOS criteria:
- Asthma confirmed with spirometry and assessment on the previous history of asthma (a methacholine challenge test and atopy testing to document the positive or negative history of asthma will be performed if there is no clinical record). Asthma severity based on GINA guidelines.
- Presence of nasal polyps. This can be based on the formal exam at Baseline Visit or historical assessment.
Exclusion
- Patients with current or past sinonasal or bronchial tumours
- Subjects who have been treated with oral antibiotics in the past month prior to surgery
- Subjects with known immunodeficiency
- Subjects with known autoimmune disease
- Subjects with other sinonasal diseases other than CRSwNP (e.g., cystic fibrosis, eosinophilic granulomatosis with polyangiitis, allergic fungal rhinosinusitis, invasive fungal sinusitis, fungal ball, dyskinetic cilia syndrome)
- Prior lung transplants
- Subjects with hypersensitivity; with allergy/intolerance to a monoclonal antibody or biologic
- Prior use of dupilumab or other biologic medications (omalizumab. mepolizumab, reslizumab,etc) 6 months before enrollment.
- Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study per protocol.
- Participation in an ongoing interventional or observational study using a biologic treatment.
- Female participants who are pregnant or breastfeeding
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06556264
Start Date
August 1 2024
End Date
December 1 2025
Last Update
August 16 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.