Analysis of Exhaled Breath by Biosensors in Adults With Asthma
The aim of this study is to investigate the pattern of organic volatile compounds (VOCs) in the exhaled breath detected by biosensors in adults with persistent mild asthma. The analysis of VOCs detected by biosensors in asthmatic adults will be compared with that in a control group of healthy subjects and with exhaled nitric oxide (NO).
Identification of breath VOC patterns may be a completely noninvasive new technique for assessing airway inflammation. A device containing a series of nanosensors can be used for breath analysis of VOC patterns through integration with a suitable algorithm for pattern recognition.
Preliminary data indicate that exhaled breath patterns detected by biosensors in healthy subjects are different from those in patients with asthma. In patients with asthma, analysis of exhaled breath using biosensors will be compared with exhaled NO measurement for studying a possible correlation with an independent method for assessing airway inflammation and with spirometry for assessing a possible correlation with lung function.
Measurement of exhaled NO is a well-established, validated, and standardized method for assessing and monitoring of airway inflammation in patients with asthma who are steroid-naive. In patients with asthma, exhaled NO concentrations are correlated with blood eosinophil cell counts and with airway hyperresponsiveness (AHR).
This study could contribute to the identification and development of a completely new non-invasive technique for assessing airway inflammation with important implications for diagnosis and therapeutic monitoring of patients with asthma.
Establishing the effect of anti-inflammatory drugs on breath analysis by biosensors in patients with asthma is relevant for future studies aimed to use this technique in asthma management.
Other: analysis of exhaled breath by biosensors
Other: measurement of exhaled nitric oxide
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Analysis of Exhaled Breath by Biosensors in Adults With Asthma: Observational Part of the Study "Effects of add-on Therapy With Oral Montelukast on the Analysis of Exhale Breath by Biosensors in Adults With Asthma|
- exhaled nitric oxide [ Time Frame: baseline ] [ Designated as safety issue: No ]
- analysis of breath by biosensors [ Time Frame: baseline ] [ Designated as safety issue: No ]
- FEV1 [ Time Frame: baseline ] [ Designated as safety issue: No ]
- FVC [ Time Frame: baseline ] [ Designated as safety issue: No ]
- FEV1/FVC ratio [ Time Frame: baseline ] [ Designated as safety issue: No ]
- FEF25%-75% [ Time Frame: baseline ] [ Designated as safety issue: No ]
- PEF [ Time Frame: baseline ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
|subjects with asthma||Other: analysis of exhaled breath by biosensors Other: measurement of exhaled nitric oxide|
|healthy subjects||Other: analysis of exhaled breath by biosensors Other: measurement of exhaled nitric oxide|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819676
|Catholic University of the Sacred Heart|
|Roma, Italy, 00168|
|Principal Investigator:||Paolo Montuschi, M.D.||Catholic University of the Sacred Heart|