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

NCT ID: NCT01976117

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2018-12-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive (COPD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

enose

Group Type: EXPERIMENTAL

enose

Intervention Type: DEVICE

Interventions

enose

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• COPD patients

Exclusion Criteria

• Exacerbation in the last 4 weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Countries

Spain

References

Sibila O, Garcia-Bellmunt L, Giner J, Rodrigo-Troyano A, Suarez-Cuartin G, Torrego A, Castillo D, Solanes I, Mateus EF, Vidal S, Sanchez-Reus F, Sala E, Cosio BG, Restrepo MI, Anzueto A, Chalmers JD, Plaza V. Airway Mucin 2 Is Decreased in Patients with Severe Chronic Obstructive Pulmonary Disease with Bacterial Colonization. Ann Am Thorac Soc. 2016 May;13(5):636-42. doi: 10.1513/AnnalsATS.201512-797OC.

Reference Type: DERIVED

PMID: 26882402 (View on PubMed)

Other Identifiers

IIBSP-ENO-2009-21

Identifier Type: -

Identifier Source: org_study_id