Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270576
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-01-30
Brief Title:
Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma
Sponsor:
National Jewish Health
Organization:
National Jewish Health
Study Overview
Official Title:
Nasal Endotoxin Challenge to Study Mucosal Inflammation in Patients With Asthma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Nasal-LPS
Brief Summary:
A phase I clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin lipopolysaccharide from E coli in healthy controls and subjects diagnosed with asthma
Detailed Description:
Patients with severe asthma can be broadly classified into three endotypes T2 T1 and T17 based on inflammatory cell and cytokine profiles Within these endotypes many patients have high levels of neutrophils in the airways and mucosal epithelium Our preliminary data suggest that neutrophils in the airways and blood of patients with severe asthma are heterogenous and that subsets exist The nature of these subsets appears to differ between T2 T1 and T17 asthma endotypes
In order to advance the field and determine the mechanisms that underpin severe neutrophilic asthma investigators plan to longitudinally assess transcriptional profiles and functional properties of neutrophil subsets that migrate to the nasal cavity following exposure to a standardized dose of Clinical Reference Center endotoxin IRBHS-3131-528 IND 018580
Investigators will recruit 15 subjects of each asthma endotype 45 total participants with asthma and 15 healthy controls LPS will be used to elicit migration of neutrophils into the nasal cavities Neutrophils will be isolated from the nasal cavities using both nasal lavage and nasal brushes 20 minutes 1 day and 3 days after endotoxin challenge Neutrophil biology will be assessed using single-cell RNAseq and ex vivo functional assays
In order to advance the field and determine the mechanisms that underpin severe neutrophilic asthma investigators plan to longitudinally assess transcriptional profiles and functional properties of neutrophil subsets that migrate to the nasal cavity following exposure to a standardized dose of Clinical Reference Center endotoxin IRBHS-3131-528 IND 018580
Investigators will recruit 15 subjects of each asthma endotype 45 total participants with asthma and 15 healthy controls LPS will be used to elicit migration of neutrophils into the nasal cavities Neutrophils will be isolated from the nasal cavities using both nasal lavage and nasal brushes 20 minutes 1 day and 3 days after endotoxin challenge Neutrophil biology will be assessed using single-cell RNAseq and ex vivo functional assays
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?:
None
Is an FDA AA801 Violation?:
None