- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01976117
E-nose Utility in the Diagnosis of Bacterial Infection in COPD
September 7, 2016 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
E-nose Utility in the Diagnosis of Bacterial Infection in Chronic Obstructive Pulmonary Disease (COPD)
Hypothesis: A commercial e-nose (Cyranose 320) is able to detect specific breathprints from patients with COPD and bacterial infection
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08025
- Hospital de La Santa Creu I Sant Pau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- COPD patients
Exclusion Criteria:
- Exacerbation in the last 4 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: enose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breathprint in exhaled breath from patients with COPD
Time Frame: Day 1
|
Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breathprint in exhaled breath from COPD patients with bacterial colonization
Time Frame: Day 1
|
Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
October 22, 2013
First Submitted That Met QC Criteria
October 29, 2013
First Posted (Estimate)
November 5, 2013
Study Record Updates
Last Update Posted (Estimate)
September 8, 2016
Last Update Submitted That Met QC Criteria
September 7, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIBSP-ENO-2009-21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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