E-nose and Inflammatory Asthma Phenotypes

Not Applicable

Completed

• Conditions: Persistent Asthma
• Interventions: Other: electronic nose

• Registration Number: NCT02026336
• Lead Sponsor: Astrid Crespo

Brief Summary

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?

Detailed Description

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-12
• Study First Submitted: 2013-12-28
• Study First Submitted QC: 2013-12-31
• Last Update Submitted: 2013-12-31
• Study First Posted: 2014-01-01
• Last Update Posted: 2014-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Adults with persistent asthma, defined as per the Global INitiative for Asthma Management (GINA) criteria, and specifically with positive bronchodilator test, or a daily peak expiratory flow (PEF) variability greater than 20%, or a positive methacholine challenge test documented in case history. Subjects were consecutively enrolled from the outpatient visits of a specialized Asthma Unit located in a tertiary University Hospital.

Exclusion Criteria

Subjects were excluded if they had a respiratory tract infection or asthma exacerbation within 30 days prior to inclusion or were receiving oral steroids or immunosuppressive treatments.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
enose	electronic nose	Electronic nose can discriminate the inflammatory asthma phenotypes, supporting their potential as a non-invasive alternative tool to induced sputum.

Primary Outcome Measures

Name	Time	Method
Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer	2 years	The recognition of volatile organic compound profiles in exhaled air by an electronic nose device can discriminate the inflammatory phenotype of patients with persistent asthma.

Trial Locations

Locations (1)

Vicente Plaza; 🇪🇸 Barcelona, Spain