How Smoking Causes COPD: Examination of Immune System Changes

July 25, 2011 updated by: St. Joseph's Healthcare Hamilton
A breathing condition known as "chronic obstructive pulmonary disease" (COPD) caused by cigarette smoking is a major health problem. The way by which smoking leads to lung disease is uncertain. Recent research done in animals provides a description of specific changes (that is a reduction) in these immune cell types as a result of cigarette smoke exposure. The study you have been asked to participate in is a pilot study to see if similar changes occur in humans who smoke. The purpose of this study is to evaluate this new method of testing blood in 3 groups of 10 people: normal non-smoking subjects, subjects who smoke with no history of lung disease and subjects who smoke and have smoking related COPD.

Study Overview

Status

Unknown

Detailed Description

The mechanism by which smoking leads to damage to lung tissue in susceptible hosts, is uncertain. Recently there has been description of specific changes (that is reduction) in the number and activity of certain key immune cell types - dendritic cells- as a result of cigarette smoke exposure. This work was done in animal models and we would like to develop methods that will allow us to examine if similar changes occur in humans who smoke. Reduced number and activity of dendritic cells would be expected to lead to increased incidence of infection - a common problem in patients with COPD.

Since dendritic cells come to the lung from the bloodstream, and one can detect them in the circulation, we will look at the dendritic cells that are present in the peripheral blood.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St Joseph's Healthcare
        • Contact:
          • Gerard Cox, MB FRCPC FRCPI
          • Phone Number: 5039 905-522-1155
          • Email: coxp@mcmaster.ca
        • Contact:
        • Principal Investigator:
          • Gerard Cox, MB FRCPC FRCPI
        • Sub-Investigator:
          • Martin Stampfli, PhD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

smokers and non-smokers

Description

Inclusion Criteria:

  • Age > 40 years
  • Healthy Subjects - Non smokers
  • FEV1/FVC > 70% predicted
  • Current Smokers - > 10 pack year smoking history
  • FEV1/FVC > 70% predicted
  • Current Smokers with COPD - > 10 pack year smoking history
  • FEV1/FVC < 70% predicted
  • Able to give informed consent

Exclusion Criteria:

  • Healthy Subjects - Reside with smokers
  • History of lung disease
  • Current Smokers - History of lung disease

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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Gerard Cox, MB FRCPC FRCPI, McMaster University

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

May 1, 2005

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 25, 2011

Last Verified

July 1, 2011

More Information

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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