The Canadian Cohort Obstructive Lung Disease (CanCOLD)

August 23, 2018 updated by: Jean Bourbeau, McGill University Health Centre/Research Institute of the McGill University Health Centre

Abstract Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in Canada. COPD is not just a disease of men, nor is it solely a disease in old age. Women have been underrepresented and early disease has not been studied. Underdiagnosis of COPD remains a significant problem, and it may indicate an unmet healthcare need. This can potentially results not only in a patient been misinformed, but can lead to incorrect management.

Epidemiological research is needed to develop a framework to combat this major health problem, by better characterization of the population of men and women at risk and patients with early disease, by better understanding which factors modifiable through health interventions are related to health perception (health-related quality of life) and disease evolution.

This will be possible through a nationwide study, the Canadian Cohort Obstructive Lung disease (CanCOLD), a prospective longitudinal study. The CanCOLD study is built on the current ongoing prevalence nationwide study, the Canadian Obstructive Lung disease "COLD" study.

The CanCOLD will be the first study to assess prevalence of disease across Canada and its consequence in men and women, and to evaluate a conceptual model of disease severity based on patient's health perception (health-related quality of life). Ultimately, this project will extend to a longitudinal follow up (3 years or beyond) and will allow to have a better understanding of the lifestyle risk factors, not only smoking but also diet, physical activity, and co morbid conditions. This will be a great asset to shift from management of a single risk factor (tobacco control) to total COPD risk management. The results of the study will greatly help to assist decision makers in developing policies to improve the diagnosis, the management of COPD and to optimize health care services use.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1500

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

  • Canada
      • Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Health Sciences Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St-Paul's Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Halifax Infirmary
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V6
        • Kingston General Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital General
      • Toronto, Ontario, Canada, M5T 2S8
        • University of Toronto
    • Quebec
      • Montreal, Quebec, Canada, H2X 2P4
        • Montreal Chest Institute
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital

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

Non-Probability Sample

Study Population

Subjects' selection and participation in CanCOLD- longitudinal cohort: Subjects will be recruited from the study site participants (total from cross-sectional ≈5,000 subjects, men and women).

Description

Inclusion Criteria:

  • All the subjects have taken part in the COLD study, a true population based prevalence study. Subjects must have an inclusion criteria of 40 years and older to participate in the COLD study.

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
Group 1
COPD moderate-severe(GOLD2-4)(post-BD FEV1/FVC<0.70 and FEV1<80% of pred.)
Group 2
COPD mild (GOLD1)(post-BD FEV1/FVC<0.70 AND FEV1>=80% of pred.)
Group 3
COPD at risk (ever smoker with post-BD FEV1/FVC>=0.70)
Group 4
"Healthy control" never smokers without respiratory disease (post-BD FEV1/FVC>=0.70.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
What risk factors other than smoking determine the development and progression of COPD.
Time Frame: One visit a year every 18 months
One visit a year every 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
What are the combinations of the disease and patient attributes that differentiate individuals (men/women) with COPD as they relate to relevant outcomes (symptoms, exacerbations, disease progression or death)
Time Frame: One visit a year 18 months
One visit a year 18 months
Is early detection of COPD with spirometry meaningful according to sex and ageing.
Time Frame: One visit a year 18 months
One visit a year 18 months

Collaborators and Investigators

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

GlaxoSmithKline
Merck Sharp & Dohme LLC
Novartis
Pfizer
Canadian Institutes of Health Research (CIHR)
Takeda
AstraZeneca
Boehringer Ingelheim
Almirall, SAS

Investigators

  • Principal Investigator: Jean Bourbeau, M.D., M.Sc., McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Wan Tan, M.D., CAAA University of British Columbia
  • Principal Investigator: François Maltais, M.D., CFBA Université Laval
  • Principal Investigator: Shawn Aaron, M.D., M.Sc., OHGC Ottawa Hospital General Campus
  • Principal Investigator: Denis O'Donnell, M.D., CEDA Queen's University (Kinsgston)
  • Principal Investigator: Darcy D Marciniuk, M.D., CCAA University of Saskatchewan
  • Principal Investigator: Robert Cowie, M.D., CBBA University of Calgary
  • Principal Investigator: Kenneth R. Chapman, M.D., M.Sc., CEAA University of Toronto
  • Principal Investigator: Paul Hernandez, M.D., CHAA Dalhousie University (Nova Scotia)
  • Principal Investigator: Mark J. FitzGerald, M.D., CAAA University of British Columbia
  • Principal Investigator: Donald Sin, M.D., CAAA University of British Columbia
  • Principal Investigator: Andrea Benedetti, Ph.D., INUD McGill University Healty Center
  • Principal Investigator: Yves Lacasse, M.D., M.Sc., CPVR Institut universitaire de cardiologie et de pneumologie de Québec
  • Principal Investigator: Pierre Ernst, M.D., McGill University
  • Principal Investigator: Harvey Coxson, M.D., University of British Columbia
  • Principal Investigator: Roger Goldstein, M.D., CEAA University of Toronto
  • Principal Investigator: Carlo Marra, Ph.D., CAAA University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2010

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 12, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (Estimate)

June 15, 2009

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRO-93326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

publications; data sharing through substudies submission

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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