Analysis of Exhaled Breath by Biosensors in Adults With Asthma
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.
Inclusion Criteria:

 -  Patient is male or female, at least 15 years of age and no more than 70 years.

 -  Patient has mild persistent asthma (step 2) of the Guidelines for the Diagnosis and
 Management of Asthma issued by the National Heart, Lung, and Blood Institute of the
 National Institutes of Health as defined by a history of symptoms at least once a week
 but less than daily (step 2) (5).

 -  Current asthma treatment includes short-acting inhaled β-agonist alone as needed.

 -  Patient fulfils all the following signs and symptoms of asthma:

 -  History of symptoms including, but not limited to dyspnea, wheezing, chest
 tightness, cough, or sputum production for at least 12 months.

 -  A forced expiratory volume in one second (FEV1) of at least 80% of the predicted
 value (pre-bronchodilator) while withholding β-agonist for at least six hours.

 -  Patient has a diagnosis of asthma as defined by 1) an increase in FEV1 or PEF of
 ≥12% (absolute value), 20 to 30 minutes after inhaled β-agonist administration,
 OR 2) a positive methacholine PC20 (provocative concentration causing a 20% fall
 in FEV1) of 8 mg/ml or lower which was performed within the previous 12 months,
 OR 3) a fall in FEV1 of at least 15% after an exercise challenge which was
 performed within the previous 12 months. β-agonist reversibility and the
 methacholine and exercise challenge tests may be satisfied within the previous 12
 months if there is adequate source documentation.

 -  Patients demonstrate symptoms requiring β-agonist use on ≥2 and ≤6 days of the
 week for the previous two weeks.

 -  Patient is able to chew a tablet.

 -  Patient is judged to be in good, stable physical and mental health (except for his/her
 asthma) based on the medical history, physical examination, and routine laboratory
 data, and appears able to successfully complete this trial.

 -  Ability to perform reproducible spirometry.

 -  Nonsmoker including no use of smokeless tobacco products in the past year.

 -  Ability of parent to provide informed consent, as evidenced by signing a copy of the
 consent form approved by the institutional review board of the subject's respective
 study institution

 Exclusion Criteria: none