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Bronchial Infection in Patients With COPD and Frequent Exacerbations.

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ClinicalTrials.gov Identifier: NCT03259022
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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
Pulmonary Disease, Chronic Obstructive

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 Type : Observational
Estimated 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 : November 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis




Primary Outcome Measures :
  1. Relationship between infection and airway innate immunity of patients with COPD and frequent exacerbations. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 6 months ]
    Mucin levels will be determined with ELISA kits

  2. Relationship between airway innate immunity and bronchial bacterial load. [ Time Frame: 6 months ]
    Mucin levels will be determined with ELISA kits.


Biospecimen Retention:   Samples With DNA
Quantitative sputum culture, oral lavage, peripheral blood and exhaled air intake will be conducted.


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
COPD patients with frequent exacerbations.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259022


Contacts
Contact: Oriol Sibila, PhD 932 91 90 00 osibila@santpau.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08026
Contact: Oriol Sibila, PhD    932 91 90 00    osibila@santpau.cat   
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

Publications:

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03259022     History of Changes
Other Study ID Numbers: IIBSP-BRO-2015-92
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Bronchitis
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Infections