Bronchial Infection in Patients With COPD and Frequent Exacerbations.

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Bronchial Infection in Patients With COPD and Frequent Exacerbations; Role of Innate Immunity and the Use of an Electronic Nose for Diagnosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03259022
• Other study ID #: IIBSP-BRO-2015-92
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2016
• Last updated: August 21, 2017
• Start date: November 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Oriol Sibila, PhD
• Phone: 932 91 90 00
• Email: osibila[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchitis
• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between infection and airway innate immunity of patients with COPD and frequent exacerbations.	Mucine levels will be determined with ELISA kits	6 months
Primary	Association between volatile organic compounds (VOCs) detected by an electronic nose and bronchial infection in patients with COPD and frequent exacerbations.	The patterns of specific volatile organic compounds in echaled air will be determined with electronic nose device.	6 months
Secondary	Relationship between airway innate immunity and systemic inflammation.	Mucin levels will be determined with ELISA kits	6 months
Secondary	Relationship between airway innate immunity and bronchial bacterial load.	Mucin levels will be determined with ELISA kits.	6 months