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The Canadian Cohort Obstructive Lung Disease (CanCOLD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by McGill University
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
AstraZeneca
Pfizer
Boehringer Ingelheim
Information provided by (Responsible Party):
Jean Bourbeau, McGill University
ClinicalTrials.gov Identifier:
NCT00920348
First received: June 12, 2009
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition
COPD
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Canadian Cohort Obstructive Lung Disease

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • What risk factors other than smoking determine the development and progression of COPD. [ Time Frame: One visit a year every 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Is early detection of COPD with spirometry meaningful according to sex and ageing. [ Time Frame: One visit a year 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood sampling

  • Biomarkers:IL-6, CRP, CC-16, SP-D"
  • DNA for genetics, epigenetic and RNA for transcriptomics
  • Markers for cardiovascular diseases: LDL, LDL and HDL sizes, Apo B, Apo A1, CRP, IL6, TNF alpha, Adiponectine, Leptine, Glucose and Insulin.

Estimated Enrollment: 1500
Study Start Date: January 2010
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920348

Contacts
Contact: Maria Sedeno, M.Sc. 514-934-1934 ext 32485 maria.sedeno@mail.mcgill.ca
Contact: Jean Bourbeau, M.D., M.Sc. 514-934-1934 ext 32158 jean.bourbeau@mcgill.ca

Locations
Canada, Alberta
Health Sciences Centre Active, not recruiting
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
St-Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Wan Tan, M.D.    604-682-2344 ext 63137    wtan@mrl.ubc.ca   
Principal Investigator: Wan Tan, M.D.         
Canada, Nova Scotia
Halifax Infirmary Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V6
Contact: Kathy Webb       kathy.webb@queensu.ca   
Sub-Investigator: Denis O'Donnell, M.D.         
Ottawa Hospital General Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Kathy Vandemheen    (613) 737-8259    kvandemheen@ohri.ca   
Sub-Investigator: Shawn Aaron, M.D., M.Sc.         
University of Toronto Active, not recruiting
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Montreal Chest Institute Recruiting
Montreal, Quebec, Canada, H2X 2P4
Contact: Palmina Mancino    514-934-1934 ext 32116    palmina.mancino@mcgill.ca   
Principal Investigator: Jean Bourbeau, M.D., M.Sc.         
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Darcy Marciniuk, M.D.    (306) 966-8298    darcy.marciniuk@usask.ca   
Sub-Investigator: Darcy Marciniuk, M.D.         
Canada
Institut universitaire de cardiologie et de pneumologie de Québec Recruiting
Quebec, Canada, G1V 4G5
Contact: Marie-Josée Breton    (418) 656-8711 ext 5823    marie-josee.breton@criucpq.ulaval.ca   
Sub-Investigator: François Maltais, M.D.         
Sponsors and Collaborators
McGill University
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
AstraZeneca
Pfizer
Boehringer Ingelheim
Investigators
Principal Investigator: Jean Bourbeau, M.D., M.Sc. McGill University Health Center
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
  More Information

No publications provided

Responsible Party: Jean Bourbeau, MD, M.Sc., McGill University
ClinicalTrials.gov Identifier: NCT00920348     History of Changes
Other Study ID Numbers: IRO-93326
Study First Received: June 12, 2009
Last Updated: November 4, 2013
Health Authority: Canada: Health Canada

Keywords provided by McGill University:
Chronic obstructive pulmonary disease
COPD
Cohort study
prospective longitudinal study
tissue bank

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

ClinicalTrials.gov processed this record on November 27, 2014