Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-03-08 @ 1:46 AM
Study NCT ID:
NCT03845257
Status:
TERMINATED
Last Update Posted:
2022-07-07
First Post:
2019-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
Sponsor:
Heidelberg University
Organization:
Study Overview
Official Title:
Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficult patient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Scientific research focuses on "eosinophilic inflammation" as it seems to guide the therapeutic regimen in patients with asthma and COPD. The primary objective of this prospective trial is to evaluate which parameter(s) best reflects eosinophilic inflammation by correlating tissue eosinophils (endobronchial biopsy, protected specimen brush sampling) with FeNO, peripheral blood eosinophils, and eosinophils in the bronchoalveolar lavage of patients with obstructive pulmonary disease.
Detailed Description:
This is a multicenter prospective trial. Enrollment will continue until 150 patients with chronic obstructive pulmonary disease and 50 patients with severe asthma have been entered into this trial and have completed bronchoscopic evaluation. In this trial, the following parameters are to be evaluated:
* Blood eosinophils (absolute and relative)
* FeNO
* Eosinophils in bronchoalveolar lavage
* Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)
* Blood eosinophils (absolute and relative)
* FeNO
* Eosinophils in bronchoalveolar lavage
* Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: