E-nose Utility in the Diagnosis of Bacterial Infection in COPD

Not Applicable

• Conditions: Pulmonary Disease, Chronic Obstructive (COPD)
• Interventions: Device: enose

• Registration Number: NCT01976117
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

Hypothesis: A commercial e-nose (Cyranose 320) is able to detect specific breathprints from patients with COPD and bacterial infection

Detailed Description

Thirty to 50% of COPD patients have airway colonization with potentially pathogenic bacteria. This is associated with worse prognosis. Currently, diagnosis of bacterial colonization relies mainly upon quantitative sputum culture. However, this method lacks good sensitivity. The electronic nose is a novel device made up of nanosensors capable of detecting specific volatile organic compounds (VOCs). OBJECTIVES: Main 1) To assess the usefulness of the electronic nose in the diagnosis of bacterial colonization in COPD. Secondary 1) To define the VOCs pattern associated with bacterial colonization. 2) To study the pattern of pulmonary and systemic inflammation associated with bacterial colonization as well its relationship with the aforementioned VOCs patterns.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• COPD patients

Exclusion Criteria

• Exacerbation in the last 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
enose	enose	-

Primary Outcome Measures

Name	Time	Method
Breathprint in exhaled breath from patients with COPD	Day 1	Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values

Secondary Outcome Measures

Name	Time	Method
Breathprint in exhaled breath from COPD patients with bacterial colonization	Day 1	Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain