Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Analysis of Exhaled Breath by Biosensors in Adults With Asthma

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00819676
First received: January 8, 2009
Last updated: July 31, 2009
Last verified: July 2009
History of Changes
  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:

MedlinePlus related topics: Asthma
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • analysis of breath by biosensors [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • FEV1 [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • FVC [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • FEV1/FVC ratio [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • FEF25%-75% [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • PEF [ Time Frame: baseline ] [ Designated as safety issue: No ]
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
Genders Eligible for Study:   Both
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

No publications provided by Catholic University of the Sacred Heart

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

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
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

ClinicalTrials.gov processed this record on March 03, 2015