Analysis of Exhaled Breath by Biosensors in Adults With Asthma - Full Text View

Purpose

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.

Condition	Intervention
Asthma	Other: analysis of exhaled breath by biosensors Other: measurement of exhaled nitric oxide


Study Type:	Observational
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

Resource links provided by NLM:

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

exhaled nitric oxide [ Time Frame: baseline ]

Secondary Outcome Measures:

analysis of breath by biosensors [ Time Frame: baseline ]
FEV1 [ Time Frame: baseline ]
FVC [ Time Frame: baseline ]
FEV1/FVC ratio [ Time Frame: baseline ]
FEF25%-75% [ Time Frame: baseline ]
PEF [ Time Frame: baseline ]


Enrollment:	47
Study Start Date:	January 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	15 Years to 70 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

asthma clinic, community sample

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819676

Locations


Italy
Catholic University of the Sacred Heart
Roma, Italy, 00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

Merck Sharp & Dohme Corp.

Investigators


Principal Investigator:	Paolo Montuschi, M.D.	Catholic University of the Sacred Heart

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Montuschi P, Santonico M, Mondino C, Pennazza G, Mantini G, Martinelli E, Capuano R, Ciabattoni G, Paolesse R, Di Natale C, Barnes PJ, D'Amico A. Diagnostic performance of an electronic nose, fractional exhaled nitric oxide, and lung function testing in asthma. Chest. 2010 Apr;137(4):790-6. doi: 10.1378/chest.09-1836. Epub 2010 Jan 15.


Responsible Party:	Paolo Montuschi, M.D. Associate Professor of Pharmacology, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00819676 History of Changes
Other Study ID Numbers:	A/220/2007
Study First Received:	January 8, 2009
Last Updated:	July 31, 2009

Additional relevant MeSH terms:


Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Nitric Oxide Bronchodilator Agents Autonomic Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Gasotransmitters Protective Agents

ClinicalTrials.gov processed this record on June 23, 2017