NCT00186719

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

First QC Date

September 13, 2005

Last Update Submit

July 25, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary DiseaseSmoking Related DiseaseImmune System Changes

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

smokers and non-smokers

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gerard Cox, MB FRCPC FRCPI

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan E Carruthers, MLT

CONTACT

905-522-1155scarruth@stjosham.on.ca

Sarah E Goodwin, BA RRT CCRC

CONTACT

905-522-1155sgoodwin@stjosham.on.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

May 1, 2005

Study Completion

April 1, 2012

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

CA(1)