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

NCT06556264 | Not Yet Recruiting Phase 4

• 1 other identifier: H24-00189
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Asthma

Outcome Measures

Primary Outcomes (1)

• Change in Cytokine levels such as GM-CSF, IFNg, TNFa, VEGF-A, Identification of Key Interleukins and chemokynes (10/CXCL10, MIP-1a/CCL3, RANTES/CCL5), compared with placebo in CRSwNP and asthma patients from baseline to week 24

  Change in GM-CSF, IFNg, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12 (p40), IL-13, IL-17A, IP-10/CXCL10, MIP-1a/CCL3, RANTES/CCL5, TNFa, VEGF-A compared with placebo in CRSwNP and asthma patients from baseline to week 24

  From baseline to 24 weeks.

Secondary Outcomes (3)

• Changes in SNOT-22, ACQ-5 and Sniffin Stick Test

  24 weeks

• Relation of changes in inflammatory profile with changes in endoscopic scores (MLK)

  24 weeks

• Relation of inflammatory profile and (FeNO and nasal FeNO)

  24 weeks

Study Arms (2)

Dupilumab

ACTIVE COMPARATOR

30 subjects undergoing ESS + dupilumab 300 (1-week post-surgery) every 2 weeks + standard of care treatment (INCS + background asthma medication) for 24 weeks

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

30 subjects undergoing ESS + placebo (1-week post-surgery) every 2 weeks + standard of care treatment (INCS + background asthma medication) for 24 weeks.

Other: Placebo

Interventions

Dupilumab DRUG

Dupilumab 300mg every 2 weeks for 24 weeks

Also known as: dupixent

Dupilumab

Placebo OTHER

Placebo 300mg every 2 weeks for 24 weeks

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Andrew Thamboo, MD: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Andrew Thamboo

  St Paul's Sonis Centre Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Thamboo

CONTACT

604-250-4174; andrew.thamboo@gmail.com

Leonora Beltran

CONTACT

604-250-4174; lbeltranjimenez@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 16, 2024
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share