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Bronchial Infection in Patients With COPD and Frequent Exacerbations.

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Unknown status
CT.gov ID
NCT03259022
Collaborator
(none)
50
Enrollment
1
Location
37
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Bronchial Infection in Patients With COPD and Frequent Exacerbations; Role of Innate Immunity and the Use of an Electronic Nose for Diagnosis.
    Study Start Date :
    Nov 1, 2016
    Anticipated Primary Completion Date :
    Jul 1, 2019
    Anticipated Study Completion Date :
    Dec 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Relationship between infection and airway innate immunity of patients with COPD and frequent exacerbations. [6 months]

      Mucine levels will be determined with ELISA kits

    2. Association between volatile organic compounds (VOCs) detected by an electronic nose and bronchial infection in patients with COPD and frequent exacerbations. [6 months]

      The patterns of specific volatile organic compounds in echaled air will be determined with electronic nose device.

    Secondary Outcome Measures

    1. Relationship between airway innate immunity and systemic inflammation. [6 months]

      Mucin levels will be determined with ELISA kits

    2. Relationship between airway innate immunity and bronchial bacterial load. [6 months]

      Mucin levels will be determined with ELISA kits.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Exclusion criteria:

    1. Presence of other lung diseases

    2. terminal concomitant disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08026

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Oriol Sibila, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT03259022
    Other Study ID Numbers:
    • IIBSP-BRO-2015-92
    First Posted:
    Aug 23, 2017
    Last Update Posted:
    Aug 23, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Bronchitis
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Aug 23, 2017