Mechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)

Bacterial Infection in COPD Clinical Trial

Official title:

Mechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01976130
• Other study ID #: IIBSP-MUC-2009-20
• Status: Active, not recruiting
• Phase: N/A
• First received: October 22, 2013
• Last updated: September 7, 2016
• Start date: June 2012
• Est. completion date: June 2018

Study information

• Verified date: September 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Study hypothesis:

Chronic Obstructive Pulmonary Disease (COPD) patients with chronic bacterial colonization have lower levels of mucins and antimicrobial peptides in their airways

Description:

Main objective:

(1) To investigate the expression of mucins and antimicrobial peptides in patients with severe COPD and their relationship with the presence of bacteria in the airway

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COPD

Exclusion Criteria:

• Acute exacerbation in the last 4 weeks

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bacterial Infection in COPD
• Bacterial Infections
• Communicable Diseases
• Infection
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Bronchoscopy

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Instituto de Salud Carlos III, Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucins in sputum		Day 1	No
Secondary	Antimicrobial peptides in sputum		Day 1	No