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Sponsors and Collaborators: |
Fraunhofer-Institute of Toxicology and Experimental Medicine German Research Foundation |
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Information provided by: | Fraunhofer-Institute of Toxicology and Experimental Medicine |
ClinicalTrials.gov Identifier: | NCT00773487 |
The primary objective of this study is to elucidate the effects of Diesel particles on the allergic inflammation in the airways of asthmatic patients.
Condition | Intervention |
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Asthma |
Other: Bonchoscopy |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Influence of Diesel Exhaust Particles (DEP) With and Without Organic Compounds on the Allergic Inflammation in Asthmatic Subjects |
Estimated Enrollment: | 15 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
A first bronchoscopy will be performed with a baseline bronchoalveolar lavage (BAL) and epithelial brushes followed by a segmental instillation of allergen (grass mix or house dust mite) alone, in combination with Diesel particles, further in combination with Diesel particles without organic compounds and saline as control into four different lung segments. After 24 hours, during a second bronchoscopy, BAL samples will be collected in these challenged segments in order to obtain cells and lavage fluid for cell biological and immunological analysis.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women will be considered for inclusion if they are:
Exclusion Criteria:
Contact: Norbert Krug, MD | ++49/(0)511/5350 ext 603 | norbert.krug@item.fraunhofer.de |
Germany, Niedersachsen | |
Fraunhofer ITEM | Recruiting |
Hannover, Niedersachsen, Germany, 30625 | |
Contact: Frank Schaumann, MD ++49(0)511/5350 ext 680 frank.schaumann@item.fraunhofer.de | |
Sub-Investigator: Frank Schaumann, MD |
Principal Investigator: | Norber Krug, MD | Fraunhofer ITEM |
Responsible Party: | Fraunhofer ITEM ( Prof. Dr. Norbert Krug ) |
Study ID Numbers: | 08/06 DEP-SFB |
Study First Received: | October 14, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00773487 |
Health Authority: | Germany: Ethics Commission |
Asthma GINA 1 Mild intermittant asthma |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity Inflammation |
Pathologic Processes Immune System Diseases Bronchial Diseases |