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

August 27, 2012 updated by: MedImmune LLC

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

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).

Study Overview

Status

Completed

Conditions

Detailed 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).

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, 15
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects referred to the hospital clinic with AECOPD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
COPD subjects
Adult male and female subjects with COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of how inflammatory pathways differ in COPD subjects
Time Frame: 6 weeks
Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker Sample Repository
Time Frame: 6 weeks
Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Investigators

  • Study Director: Rene Van Der Merwe, MBChB, MFPM, MedImmune Ltd
  • Principal Investigator: Prof. Connor Burke, BCF Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

August 28, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-RI-INDP-1048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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