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E-nose and Inflammatory Asthma Phenotypes

A

Astrid Crespo

Status

Completed

Conditions

Persistent Asthma

Treatments

Other: electronic nose

Study type

Interventional

Funder types

Other

Identifiers

NCT02026336
10/122/1161

Details and patient eligibility

About

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?

Full 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.

Enrollment

52 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

52 participants in 1 patient group

enose
No Intervention group
Description:
Electronic nose can discriminate the inflammatory asthma phenotypes, supporting their potential as a non-invasive alternative tool to induced sputum.
Treatment:
Other: electronic nose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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