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

Pulmonary Disease, Chronic Obstructive (COPD) Clinical Trial

Official title:

E-nose Utility in the Diagnosis of Bacterial Infection in Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01976117
• Other study ID #: IIBSP-ENO-2009-21
• Status: Active, not recruiting
• Phase: N/A
• First received: October 22, 2013
• Last updated: September 7, 2016
• Start date: June 2012
• Est. completion date: December 2018

Study information

• Verified date: September 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COPD patients

Exclusion Criteria:

• Exacerbation in the last 4 weeks

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bacterial Infections
• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Disease, Chronic Obstructive (COPD)

Intervention

Device:
• enose

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breathprint in exhaled breath from patients with COPD	Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values	Day 1
Secondary	Breathprint in exhaled breath from COPD patients with bacterial colonization	Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values	Day 1