Immunologic Impact of Dupilumab in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps

Launched by DR. ANDREW THAMBOO, MD · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called dupilumab can help reduce inflammation in adults who have both chronic rhinosinusitis with nasal polyps and moderate to severe asthma. These patients will be undergoing a procedure called Endoscopic Sinus Surgery (ESS). The researchers want to see if adding dupilumab to their regular treatment can improve inflammation in both the sinuses and lungs over a period of 24 weeks. This study is important because it may help find out if treating one part of the airway, like the lungs, can also help another part, like the sinuses, leading to better treatments for asthma and sinus problems.

To be eligible for this trial, participants need to be at least 19 years old and diagnosed with both chronic rhinosinusitis with nasal polyps and asthma. They must be planning to have Endoscopic Sinus Surgery. However, certain individuals can’t participate, such as those with specific types of tumors or autoimmune diseases, or those who have recently taken antibiotics or certain other medications. If someone joins the study, they will receive dupilumab along with their usual care and will be monitored to understand how their condition changes over the study period. This research could provide valuable insights into treating these airway conditions more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients over the age of 19.
• • Patients undergoing Endoscopic Sinus Surgery (ESS)
• * Patients with CRSwNP with moderate-severe asthma according to 2020 EPOS criteria:
• • 1. 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.
• • 2. Presence of nasal polyps. This can be based on the formal exam at Baseline Visit or historical assessment.
• Exclusion Criteria:
• • 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