Clinical Trials Directory

Trials / Completed

CompletedNCT00819676

Analysis of Exhaled Breath by Biosensors in Adults With Asthma

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
Phase
Study type
Observational
Enrollment
47 (actual)
Sponsor
Catholic University of the Sacred Heart · Academic / Other
Sex
All
Age
15 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERanalysis of exhaled breath by biosensors
OTHERmeasurement of exhaled nitric oxide

Timeline

Start date
2009-01-01
Primary completion
2009-07-01
Completion
2009-07-01
First posted
2009-01-09
Last updated
2009-08-03

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT00819676. Inclusion in this directory is not an endorsement.