E-nose and Inflammatory Asthma Phenotypes

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?

Completed

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Key information

Conditions

Persistent Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vicente Plaza

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

electronic nose

Other

Exhaled gas to assess e-nose VOC profiles was collected as described. Briefly, patients breathed through a mouthpiece into a 2-way nonrebreathing valve (Hans rudolph 2700, Hans rudolph, Kansas City, Mo) with an inspiratory VOC filter and an expiratory silica reservoir to dry the expired air. Expiratory air was collected in a 10-L "Tedlar bag". Within not more than 10 minutes, the bag was connected to the e-nose device (Cyranose 320®; Smith Detections, Pasadena, CA), provided with a 32 organic polymeric nano-composite sensor array, for 5 minutes and changes in the nano-sensor electrical resistance generated a breath-print VOC profile.

Other names: Cyranose 320®; Smith Detections, Pasadena, CA

Primary outcomes

Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Astrid Crespo

Other

Registry information

Official study title

Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jan 1, 2014
Registry last updated: Jan 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed