Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295737
Status:
TERMINATED
Last Update Posted:
2008-01-16
First Post:
2006-02-22
Brief Title:
Effect of an Immunotoxin on Activated Human Macrophages in Those With Allergic Rhinitis or Mild Intermittent Asthma
Sponsor:
Fraunhofer-Institute of Toxicology and Experimental Medicine
Organization:
Fraunhofer-Institute of Toxicology and Experimental Medicine
Study Overview
Official Title:
0504 IMHOTEP-1 FHG Ex Vivo Effect of an Immunotoxin on Activated Human Macrophages From Atopics After Segmental Instillation of Allergen and Endotoxin
Status:
TERMINATED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
proof of mechanism achieved with fewer subjects than anticipated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to isolate macrophages by using bronchoalveolar lavage BAL for different in vitro experiments
Therefore following a baseline BAL allergen endotoxin and saline will be instilled into three different lung segments during the first bronchoscopy After 24 hours during a second bronchoscopy BAL fluid will be collected in these challenged segments to harvest invaded cells for in vitro experimentation In addition segmental bronchial biopsies will be taken to assess the degree of local inflammation
Therefore following a baseline BAL allergen endotoxin and saline will be instilled into three different lung segments during the first bronchoscopy After 24 hours during a second bronchoscopy BAL fluid will be collected in these challenged segments to harvest invaded cells for in vitro experimentation In addition segmental bronchial biopsies will be taken to assess the degree of local inflammation
Detailed Description:
None
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