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How Smoking Causes COPD: Examination of Immune System Changes

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ClinicalTrials.gov Identifier: NCT00186719
Recruitment Status : Unknown
Verified July 2011 by St. Joseph's Healthcare Hamilton.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
St. Joseph's Healthcare Hamilton

Study Description
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Brief Summary:
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.

Condition or disease
Chronic Obstructive Pulmonary Disease

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Smoking Causes COPD: Examination of Immune System Changes
Study Start Date : May 2005
Estimated Study Completion Date : April 2012

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
smokers and non-smokers
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186719


Contacts
Contact: Susan E Carruthers, MLT 905-522-1155 ext 2208 scarruth@stjosham.on.ca
Contact: Sarah E Goodwin, BA RRT CCRC 905-522-1155 ext 6130 sgoodwin@stjosham.on.ca

Locations
Canada, Ontario
St Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Gerard Cox, MB FRCPC FRCPI    905-522-1155 ext 5039    coxp@mcmaster.ca   
Contact: Martin Stampfli, PhD    905-525-9140 ext 22473    stampfli@mcmaster.ca   
Principal Investigator: Gerard Cox, MB FRCPC FRCPI         
Sub-Investigator: Martin Stampfli, PhD         
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Gerard Cox, MB FRCPC FRCPI McMaster University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr. Gerard Cox, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT00186719     History of Changes
Other Study ID Numbers: 02-2182
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by St. Joseph's Healthcare Hamilton:
Chronic Obstructive Pulmonary Disease
Smoking Related Disease
Immune System Changes

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases