Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556264
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Immunologic Impact of Dupilumab in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Determining the Immunologic Impact of Dupilumab on the Unified Airway System in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 patients treated with 300 mg of dupilumab twice daily for 24 weeks as an add-on treatment to the standard of care intranasal corticosteroids INCS backgroung asthma medication compare to the placebo standard of care treatment only
The investigators hypothesize that the study of the immune profile in patients with CRSwNP and asthma would give a better understanding of the mechanism involved in the airway inflammatory response Determining the molecular profiles of the upper and lower airways after dupilumab treatment has not been studied yet
Dupilumab has demonstrated effectiveness in treating both Chronic Rhinosinusitis with Nasal Polyps CRSwNP and asthma conditions characterized by Type 2 inflammation by inhibiting the IL-4 and IL-13 signalling pathways However it remains unclear how immunological changes occur in paired tissues of the upper sinus and lower lung airways in patients treated with biologics compared to those receiving standard therapies Additionally it is not well understood whether improvements in one airway system eg the lungs are mirrored in the other eg the sinuses which could result in differing clinical responses This study aims to address these gaps by examining the comparative effects of Dupilumab versus standard treatments on both airway systems to determine if therapeutic effects are consistently observed across both systems and to understand the potential implications for clinical responsiveness
The investigators hypothesize that the study of the immune profile in patients with CRSwNP and asthma would give a better understanding of the mechanism involved in the airway inflammatory response Determining the molecular profiles of the upper and lower airways after dupilumab treatment has not been studied yet
Dupilumab has demonstrated effectiveness in treating both Chronic Rhinosinusitis with Nasal Polyps CRSwNP and asthma conditions characterized by Type 2 inflammation by inhibiting the IL-4 and IL-13 signalling pathways However it remains unclear how immunological changes occur in paired tissues of the upper sinus and lower lung airways in patients treated with biologics compared to those receiving standard therapies Additionally it is not well understood whether improvements in one airway system eg the lungs are mirrored in the other eg the sinuses which could result in differing clinical responses This study aims to address these gaps by examining the comparative effects of Dupilumab versus standard treatments on both airway systems to determine if therapeutic effects are consistently observed across both systems and to understand the potential implications for clinical responsiveness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None