Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188871
Status:
WITHDRAWN
Last Update Posted:
2024-05-09
First Post:
2023-12-18
Brief Title:
Early-onset Dupilumab Effects in CRSwNP
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Early Changes in Type 2 Inflammatory Cytokines Respiratory Oscillometry and Sinonasal Microbiome With Dupilumab Treatment for Chronic Rhinosinusitis With Nasal Polyps
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study is no longer interventional A new observational protocol was created
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
While it is known that Dupilumab has profound effects in patients with CRSwNP these are often seen months later after treatment initiation however in practice patients often endorse feeling significantly better within days of their first injection No studies have investigated the molecular basis for such an acute change This study proposes that specific cytokine changes in phenotype in addition to microbiome and oscillometry effects play a synergistic role in producing this effect
Detailed Description:
This is a single center prospective controlled pilot study investigating the acute-onset changes across multiple parameters from immunology to microbiome and pulmonary physiology in patients with CRSwNP after receiving initial doses of dupilumab therapy In total eligible participants will be enrolled in the study for a total of 3 weeks during which they will receive two injections of 300 mg of dupilumab There will be a total of 8 study visits with the 1st visit being a 1-month pre-intervention baseline allowing each patient to serve as independent controls The next seven visits will be at the following time points Day of the 1st injection 24-hrs after the first injection 48 hrs after the first injection one week after the first injection two weeks after the first injection prior to receiving the second injection 24hrs after receiving the 2nd injection and the 3-week timepoint 1 week after the second injection At each visit patients will be screened for side effects and nasal endoscopy will be performed as well as collection of nasal secretions via sinus packings that are placed in both nares for five minutes The packings will subsequently be removed and per the collection protocol will undergo centrifugation aliquoting and storage in a -80 freezer for future cytokine analysis via ELISA assays for various cytokine markers of type 2 inflammation neutrophil activity and mucin type At specific visits additional measures will be collected including Staph Aureus swabs for qPCR and cell culture SNOT-22 surveys and smell testing and oscillometry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None