Back to resultsMechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Bacterial Infection in COPD
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
About this trial
This is an interventional basic science trial for Bacterial Infection in COPD
Eligibility Criteria
Inclusion Criteria:
- COPD
Exclusion Criteria:
- Acute exacerbation in the last 4 weeks
Sites / Locations
- Hospital de la Santa Creu i Sant Pau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bronchoscopy
Arm Description
Procedure
Outcomes
Primary Outcome Measures
Mucins in sputum
Secondary Outcome Measures
Antimicrobial peptides in sputum
Full Information
NCT ID
NCT01976130
First Posted
October 22, 2013
Last Updated
September 7, 2016
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Instituto de Salud Carlos III, Sociedad Española de Neumología y Cirugía Torácica
1. Study Identification
Unique Protocol Identification Number
NCT01976130
Brief Title
Mechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Mechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Instituto de Salud Carlos III, Sociedad Española de Neumología y Cirugía Torácica
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study hypothesis:
Chronic Obstructive Pulmonary Disease (COPD) patients with chronic bacterial colonization have lower levels of mucins and antimicrobial peptides in their airways
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection in COPD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bronchoscopy
Arm Type
Experimental
Arm Description
Procedure
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Primary Outcome Measure Information:
Title
Mucins in sputum
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Antimicrobial peptides in sputum
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD
Exclusion Criteria:
Acute exacerbation in the last 4 weeks
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Mechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)
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