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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorDr. Andrew Thamboo, MD

About this trial

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 want to understand how adding a medication called dupilumab to their usual treatment affects inflammation in their upper and lower airways over 24 weeks.

Dupilumab works by blocking certain signals in the immune system that contribute to inflammation in both the sinuses and the lungs. By studying how this medication changes the immune profiles of both airway systems, investigators hope to learn more about the underlying causes of airway inflammation in these conditions.

This research is important because it may help understand if treating inflammation in one part of the airway (like the lungs) has a similar effect on inflammation in another part (like the sinuses). This could lead to better treatments for people with CRSwNP and asthma, targeting the root causes of their symptoms more effectively.

Eligibility criteria

Qualifiers

Patients over the age of 19.

Patients undergoing Endoscopic Sinus Surgery (ESS)

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dupilumab
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Dr. Andrew Thamboo, MD

Lead sponsor

St. Paul's Sinus Centre

Sponsor institution

Sanofi

Collaborator