Bronchial Infection in Patients With COPD and Frequent Exacerbations.

NCT03259022 | Unknown

• 1 other identifier: IIBSP-BRO-2015-92
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis:

1. 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. 2.The electronic nose is able to detect patterns of specific VOCs for exacerbations of infectious origin.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Relationship between infection and airway innate immunity of patients with COPD and frequent exacerbations.

  Mucine levels will be determined with ELISA kits

  6 months

• 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 Outcomes (2)

• Relationship between airway innate immunity and systemic inflammation.

  6 months

• Relationship between airway innate immunity and bronchial bacterial load.

  6 months

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD patients with frequent exacerbations.

You may qualify if:

• Diagnosis of COPD according to national and international guidelines.
• Presence of ≥ 2 exacerbations requiring admission in the last 12 months.
• Signature of informed consent.

You may not qualify if:

• Presence of other lung diseases
• terminal concomitant disease

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

RECRUITING

Related Publications (25)

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Biospecimen

Retention: SAMPLES WITH DNA

Quantitative sputum culture, oral lavage, peripheral blood and exhaled air intake will be conducted.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oriol Sibila, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oriol Sibila, PhD

CONTACT

932 91 90 00; osibila@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: August 23, 2017
• Study Start: November 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

ES (1)