Effect of an Immunotoxin on Activated Human Macrophages in Those With Allergic Rhinitis or Mild Intermittent Asthma
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|ClinicalTrials.gov Identifier: NCT00295737|
Recruitment Status : Terminated (proof of mechanism achieved with fewer subjects than anticipated)
First Posted : February 24, 2006
Last Update Posted : January 16, 2008
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.
|Condition or disease||Intervention/treatment|
|Atopy Rhinitis Bronchial Asthma||Procedure: bronchoscopy, allergen/endotoxin instillation|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||05/04 IMHOTEP-1 FHG: Ex Vivo Effect of an Immunotoxin on Activated Human Macrophages From Atopics After Segmental Instillation of Allergen and Endotoxin|
|Study Start Date :||February 2006|
|Primary Completion Date :||January 2008|
|Study Completion Date :||January 2008|
- number of macrophages in bronchoalveolar lavage [ Time Frame: one day after challenge ]
- number of other BAL cells [ Time Frame: one day after challenge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295737
|Hannover, Germany, 30625|
|Principal Investigator:||Jens Hohlfeld, MD||Fraunhofer ITEM|