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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Dupilumab
DrugDupilumab 300mg every 2 weeks for 24 weeks
Placebo
Other interventionPlacebo 300mg every 2 weeks for 24 weeks
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: DupilumabActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
From baseline to 24 weeks.Secondary outcomes
1
Changes in SNOT-22, ACQ-5 and Sniffin Stick Test
Relation of changes in the inflammatory profiles with changes in symptom control (SNOT-22, ACQ-5,Sniffin Stick test) compared with placebo at baseline and 24 weeks.
Time frame
24 weeks2
Relation of changes in inflammatory profile with changes in endoscopic scores (MLK)
Correlate the changes in the inflammatory profiles with changes in endoscopy scores (MLK scores) compared with placebo at baseline and 24 weeks.
Time frame
24 weeks3
Relation of inflammatory profile and (FeNO and nasal FeNO)
Correlate the changes in the inflammatory profiles with changes in the pulmonary function measured by spirometry FEV1 values and standard and nasal fractional exhaled nitric oxide (FeNO and nasal FeNO) compared with placebo at baseline and 24 weeks
Time frame
24 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: