Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Fraunhofer-Institute of Toxicology and Experimental Medicine |
---|---|
Information provided by: | Fraunhofer-Institute of Toxicology and Experimental Medicine |
ClinicalTrials.gov Identifier: | NCT00743704 |
The primary objective of this pilot study is to establish a model of neutrophil airway inflammation for future testing of anti-inflammatory substances in an early stage of clinical development. Moreover, the suitability of an electronic nose for early detection and diagnosis of airway inflammation will be determined.
Condition | Intervention |
---|---|
Healthy Subjects |
Other: ozoneexposure |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment |
Official Title: | Novel Noninvasive Techniques to Study Neutrophil Airway Inflammation in an Ozone Challenge Model |
Estimated Enrollment: | 15 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Experimental ozone exposure of human subjects is known to induce transient neutrophilic airway inflammation with sputum neutrophilia and elevated concentrations of inflammatory mediators in bronchoalveolar lavage and sputum supernatants. In this study, ozone at a concentration of 250 ppb will be inhaled for three hours in an ozone challenge chamber.
In a recent study, ozone challenge has been discussed as a model for pulmonary diseases dominated by neutrophilic inflammation such as COPD, providing the possibility to test new anti-inflammatory substances in early stages of clinical development.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Women will be considered for inclusion if they are:
Exclusion Criteria:
Contact: Jens Hohlfeld, MD | +49(0)511/5350 ext 603 | jens.hohlfeld@item.fraunhofer.de |
Germany, Niedersachsen | |
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin | Recruiting |
Hannover, Niedersachsen, Germany, 30625 | |
Contact: Heike Biller, MD +49(0)511/5350 ext 623 heike.biller@item.fraunhofer.de |
Principal Investigator: | Jens Hohlfeld, MD | Fraunhofer ITEM |
Responsible Party: | Fraunhofer-Institute of Toxicology and Experimental Medicine ( Jens Hohlfeld, MD ) |
Study ID Numbers: | 08/04 Ozelot |
Study First Received: | August 28, 2008 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00743704 |
Health Authority: | Germany: Ethics Commission |
Healthy Inflammation |
Pathologic Processes |