How Smoking Causes COPD: Examination of Immune System Changes

NCT ID: NCT00186719

Last Updated: 2011-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

St. Joseph's Healthcare Hamilton

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gerard Cox, MB FRCPC FRCPI

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Susan E Carruthers, MLT

Role: CONTACT

905-522-1155 ext. 2208

Sarah E Goodwin, BA RRT CCRC

Role: CONTACT

905-522-1155 ext. 6130

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gerard Cox, MB FRCPC FRCPI

Role: primary

905-522-1155 ext. 5039

Martin Stampfli, PhD

Role: backup

905-525-9140 ext. 22473

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

02-2182

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Innate Immunity in COPD
NCT05743582 RECRUITING