Ignite Creation Date:
2024-05-05 @ 9:07 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00819676
Status:
COMPLETED
Last Update Posted:
2009-08-03
First Post:
2009-01-08
Brief Title:
Analysis of Exhaled Breath by Biosensors in Adults With Asthma
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None