Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05365841
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2022-01-18
Brief Title:
Role of Epithelial Barrier Integrity in Biologic Treatment Response of Severe Asthmatics WithOut Chronic Rhinosinusitis With Nasal Polyps CRSwNP
Sponsor:
University of Crete
Organization:
University of Crete
Study Overview
Official Title:
Role of Epithelial Barrier Integrity in Biologic Treatment Response of Severe Asthmatics WithOut Chronic Rhinosinusitis With Nasal Polyps CRSwNP Can Shedding of Epithelial Barrier Proteins be Used as Biomarker in Severe Asthma WithOut CRSwNP Management
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
Advances in understanding the pathophysiology of asthma development and severity have pointed towards a prominent role of the bronchial epithelium especially in more chronic and severe disease Studies suggest that airway eosinophilic inflammation in asthma is linked to epithelial injury and structural changes of the airways co called airway wall remodeling Together the chronic airway inflammation and remodeling are associated with bronchial hyperresponsiveness fixed airflow obstruction or progressive loss of lung function and clinical severity of asthma Chronic rhinosinusitis with nasal polyps CRSwNP is another respiratory inflammatory disease often co-existing with severe asthma sharing similar pathophysiology The investigators hypothesize that epithelial barrier integrity may play a role in the pathophysiology of severe eosinophilic asthma and nasal polyposis and in response to anti-IL5 therapy of severe asthmatics and that shedding of epithelial barrier proteins may be used as biomarker in the management of severe asthma In order to study that the investigators will conduct a prospective cohort study of adult severe asthmatics without CRSwNP who live on the island of Crete Greece and who meet the criteria for entering anti-IL5 treatment as assessed by pulmonologist The participants will be recruited with a convenience sampling in a period of 2 years under real life conditions and will be followed up for 1 year after treatment initiation A control group of subjects diagnosed with nasal polyposis without severe asthma will be used Eligible subjects will undergo clinical assessment with radiological CT and endoscopic investigations Samples of serum sputum nasal secretions as well as nasal and bronchial biopsies will be obtain for assessing clinicopathological differences among the 3 groups but also response to anti-IL5 therapy in SEA wo CRSwNP
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None