A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337661
• Other study ID #: CD-RI-INDP-1048
• Status: Completed
• Phase: N/A
• First received: April 13, 2011
• Last updated: August 27, 2012
• Start date: April 2011
• Est. completion date: February 2012

Study information

• Verified date: August 2012
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).

Description:

This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease

• Current or ex-smoker with a tobacco history of 15 or more pack years

• Females of childbearing potential must use birth control for the duration of the study.

Exclusion Criteria:

• Evidence or history of clinically significant disease

• Subjects with asthma

• Subjects taking anti-leukotriene medications

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Ireland	Research Site	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of how inflammatory pathways differ in COPD subjects	Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.	6 weeks	No
Secondary	Biomarker Sample Repository	Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD.	6 weeks	No

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