Novel Noninvasive Techniques to Study Neutrophil Airway Inflammation in an Ozone Challenge Model
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Novel Noninvasive Techniques to Study Neutrophil Airway Inflammation in an Ozone Challenge Model|
- Change of smellprints in exhaled breath [ Time Frame: at the end of ozone exposure and 6 h and 24 h after the start of challenge compared with baseline and exposure to filtered air ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||March 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743704
|Fraunhofer-Institut für Toxikologie und Experimentelle Medizin|
|Hannover, Niedersachsen, Germany, 30625|
|Principal Investigator:||Jens Hohlfeld, MD||Fraunhofer ITEM|