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Trial record 1 of 1 for:    NCT00920348
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The Canadian Cohort Obstructive Lung Disease (CanCOLD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00920348
Recruitment Status : Active, not recruiting
First Posted : June 15, 2009
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
AstraZeneca
Pfizer
Boehringer Ingelheim
Novartis
Takeda
Merck Sharp & Dohme Corp.
Almirall, SAS
Information provided by (Responsible Party):
Jean Bourbeau, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date June 12, 2009
First Posted Date June 15, 2009
Last Update Posted Date August 27, 2018
Study Start Date January 2010
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 4, 2013)
What risk factors other than smoking determine the development and progression of COPD. [ Time Frame: One visit a year every 18 months ]
Original Primary Outcome Measures
 (submitted: June 12, 2009)
CanCOLD aims to be the first study to characterize COPD among a random sample of Canadians using spirometry as one of the main outcome. [ Time Frame: One visit a year ]
Change History
Current Secondary Outcome Measures
 (submitted: November 4, 2013)
  • 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 ]
  • Is early detection of COPD with spirometry meaningful according to sex and ageing. [ Time Frame: One visit a year 18 months ]
Original Secondary Outcome Measures
 (submitted: June 12, 2009)
  • To estimate the relationship between structural/biological and physiological variables and symptoms, functional status, comorbid conditions and perception of health. [ Time Frame: One visit a year ]
  • To compare the relationship among models variables between individuals with COPD and their non-COPD peers (those at risk and health peers). [ Time Frame: One visit a year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Canadian Cohort Obstructive Lung Disease
Official Title The Canadian Cohort Obstructive Lung Disease
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.
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).
Condition
  • COPD
  • Chronic Obstructive Pulmonary Disease
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 4, 2013)
1500
Original Estimated Enrollment
 (submitted: June 12, 2009)
1600
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00920348
Other Study ID Numbers IRO-93326
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: publications; data sharing through substudies submission
Responsible Party Jean Bourbeau, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
  • Canadian Institutes of Health Research (CIHR)
  • GlaxoSmithKline
  • AstraZeneca
  • Pfizer
  • Boehringer Ingelheim
  • Novartis
  • Takeda
  • Merck Sharp & Dohme Corp.
  • 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
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date August 2018