Persistent Asthma Clinical Trial
Official title:
Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer
Patients with persistent asthma have different inflammatory phenotypes. The electronic nose
is a new technology capable of distinguishing volatile organic compound breath-prints in
exhaled breath among different pulmonary diseases.
Question of the study. Is the electronic nose breath-print analysis able to discriminate
among different inflammatory asthma phenotypes?
Materials/patients and methods. Fifty-two consecutively enrolled patients with persistent
asthma were included in a cross-sectional proof of concept study. Inflammatory asthma
phenotypes were recognized by inflammatory cell counts in induced sputum. Breath-prints were
analyzed by discriminant analysis on principal component reduction, resulting in
cross-validated accuracy values. Receiver Operating Characteristics (ROC) was calculated.
Legal and ethical aspects The study was conducted in accordance with the Declaration of
Helsinki principles (18th Word Medical Assembly, 1964) and was approved by the Clinical
Research Ethics Committee (approval number: IIBSP/10/122/1161) of our institution. The
participants provided their written informed consent to participate in this study and
personal identification data were anonymized.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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