Bronchial Infection in Patients With COPD and Frequent Exacerbations.
NCT ID: NCT03259022
Last Updated: 2017-08-23
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
50 participants
Study Classification
OBSERVATIONAL
Study Start Date
2016-11-30
Study Completion Date
2019-12-31
Brief Summary
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Hypothesis:
1. Innate immunity is altered in certain patients with COPD and frequent exacerbations, a fact that makes them more susceptible to being infected by bacteria.
2. The electronic nose is able to detect patterns of specific VOCs for exacerbations of infectious origin.
1. Innate immunity is altered in certain patients with COPD and frequent exacerbations, a fact that makes them more susceptible to being infected by bacteria.
2. The electronic nose is able to detect patterns of specific VOCs for exacerbations of infectious origin.
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Detailed Description
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Bronchial infection has been described as the leading cause of COPD exacerbations. Different studies with invasive endoscopic techniques have demonstrated the presence of bacteria in the air in 40-70% of exacerbations of the disease. In addition, these patients have a higher concentration of cells and proinflammatory cytokines in the airway. This increased inflammation is associated with more frequent and more severe exacerbations, which worsen this vicious circle.
It is not known why some patients with COPD are more susceptible than others to bronchial, acute or chronic infection. Recent studies have suggested the importance of lung innate immunity, both humoral (proteins with antibiotic activity, inflammatory mediators) and cell (neutrophils, macrophages) as the key to the defense of the lung against infectious agents external factor. There may be a bidirectional relationship between immune response and bronchial infection in COPD exacerbations.
Te main objectives of our study are: 1. To study the expression of mucin, PAM and TLR in the airway of patients with COPD and frequent exacerbations (FE) and its relationship with the infection of the airway. 2. Determine the patterns of volatile organic compounds (VOCs) detected by electronic nose associated with bronchial infection in patients with COPD and FE.
Secondary objectives: 1. To study the relationship between the expression of mucin, PAM and TLR with pulmonary and systemic inflammation. 2. To study the relationship between the expression of mucin, PAM and TLR with bronchial bacterial load. 3. To study the expression of mucin, PAM and TLR at the time of COPD exacerbations and subsequent clinical phase stability. 4. Determine VOC patterns for specific pathogens (H. influenzae, S. pneumoniae, P. aeurginosa). 5. To study the time evolution of patterns of VOCs after a COPD exacerbation.
It is not known why some patients with COPD are more susceptible than others to bronchial, acute or chronic infection. Recent studies have suggested the importance of lung innate immunity, both humoral (proteins with antibiotic activity, inflammatory mediators) and cell (neutrophils, macrophages) as the key to the defense of the lung against infectious agents external factor. There may be a bidirectional relationship between immune response and bronchial infection in COPD exacerbations.
Te main objectives of our study are: 1. To study the expression of mucin, PAM and TLR in the airway of patients with COPD and frequent exacerbations (FE) and its relationship with the infection of the airway. 2. Determine the patterns of volatile organic compounds (VOCs) detected by electronic nose associated with bronchial infection in patients with COPD and FE.
Secondary objectives: 1. To study the relationship between the expression of mucin, PAM and TLR with pulmonary and systemic inflammation. 2. To study the relationship between the expression of mucin, PAM and TLR with bronchial bacterial load. 3. To study the expression of mucin, PAM and TLR at the time of COPD exacerbations and subsequent clinical phase stability. 4. Determine VOC patterns for specific pathogens (H. influenzae, S. pneumoniae, P. aeurginosa). 5. To study the time evolution of patterns of VOCs after a COPD exacerbation.
Conditions
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Pulmonary Disease, Chronic Obstructive
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
1. Diagnosis of COPD according to national and international guidelines.
2. Presence of ≥ 2 exacerbations requiring admission in the last 12 months.
3. Signature of informed consent.
2. Presence of ≥ 2 exacerbations requiring admission in the last 12 months.
3. Signature of informed consent.
Exclusion Criteria
1. Presence of other lung diseases
2. terminal concomitant disease
2. terminal concomitant disease
Minimum Eligible Age
45 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Oriol Sibila, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Site Status
RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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References
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BACKGROUND
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Reference Type
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Reference Type
BACKGROUND
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BACKGROUND
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Reference Type
BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
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Other Identifiers
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IIBSP-BRO-2015-92
Identifier Type: -
Identifier Source: org_study_id
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