Status:
COMPLETED
Analysis of Exhaled Breath by Biosensors in Adults With Asthma
Lead Sponsor:
Catholic University of the Sacred Heart
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Asthma
Eligibility:
All Genders
15-70 years
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 detect...
Eligibility Criteria
Inclusion
- 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
- none
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00819676
Start Date
January 1 2009
End Date
July 1 2009
Last Update
August 3 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Catholic University of the Sacred Heart
Roma, Italy, 00168