Analysis of Exhaled Breath by Biosensors in Adults With Asthma

Tracking Information
First Submitted Date	January 8, 2009
First Posted Date	January 9, 2009
Last Update Posted Date	August 3, 2009
Study Start Date	January 2009
Actual Primary Completion Date	July 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 8, 2009)	exhaled nitric oxide [ Time Frame: baseline ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00819676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: January 8, 2009)	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 ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Analysis of Exhaled Breath by Biosensors in Adults With Asthma
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
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case Control; Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	asthma clinic, community sample
Condition	Asthma
Intervention	Other: analysis of exhaled breath by biosensors; Other: measurement of exhaled nitric oxide
Study Groups/Cohorts	subjects with asthma Interventions: Other: analysis of exhaled breath by biosensors Other: measurement of exhaled nitric oxide; healthy subjects Interventions: Other: analysis of exhaled breath by biosensors Other: measurement of exhaled nitric oxide
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: July 31, 2009)	47
Original Estimated Enrollment; (submitted: January 8, 2009)	45
Actual Study Completion Date	July 2009
Actual Primary Completion Date	July 2009 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	15 Years to 70 Years (Child, Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Italy
Removed Location Countries
Administrative Information
NCT Number	NCT00819676
Other Study ID Numbers	A/220/2007
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Paolo Montuschi, M.D. Associate Professor of Pharmacology, Catholic University of the Sacred Heart
Study Sponsor	Catholic University of the Sacred Heart
Collaborators	Merck Sharp & Dohme Corp.
Investigators	Principal Investigator: Paolo Montuschi, M.D. Catholic University of the Sacred Heart
PRS Account	Catholic University of the Sacred Heart
Verification Date	July 2009