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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01976117
Enrollment
Unknown
Registered
2013-11-05
Start date
2012-06-30
Completion date
2018-12-31
Last updated
2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive (COPD)

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.

Interventions

DEVICEenose

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* COPD patients

Exclusion criteria

* Exacerbation in the last 4 weeks

Design outcomes

Primary

MeasureTime frameDescription
Breathprint in exhaled breath from patients with COPDDay 1Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values

Secondary

MeasureTime frameDescription
Breathprint in exhaled breath from COPD patients with bacterial colonizationDay 1Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026