Clinical trial NCT00920348: The Canadian Cohort Obstructive Lung Disease
Official title: The Canadian Cohort Obstructive Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
COPD
Cohort study
prospective longitudinal study
tissue bank
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: GlaxoSmithKline
name: AstraZeneca
name: Pfizer
name: Boehringer Ingelheim
name: Novartis
name: Takeda
name: Merck Sharp & Dohme LLC
name: Almirall, SAS
First posted: 2009-06-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


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.

Primary outcomes:
measure: What risk factors other than smoking determine the development and progression of COPD.
timeFrame: One visit a year every 18 months
Secondary outcomes:
measure: 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)
timeFrame: One visit a year 18 months
measure: Is early detection of COPD with spirometry meaningful according to sex and ageing.
timeFrame: One visit a year 18 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Health Sciences Centre
state: Alberta
city: Vancouver
country: Canada
facility: St-Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Halifax Infirmary
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital General
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Montreal
country: Canada
facility: Montreal Chest Institute
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Jean Bourbeau, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: CAAA University of British Columbia
name: Wan Tan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CFBA Université Laval
name: François Maltais, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: OHGC Ottawa Hospital General Campus
name: Shawn Aaron, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: CEDA Queen's University (Kinsgston)
name: Denis O'Donnell, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CCAA University of Saskatchewan
name: Darcy D Marciniuk, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CBBA University of Calgary
name: Robert Cowie, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CEAA University of Toronto
name: Kenneth R. Chapman, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHAA Dalhousie University (Nova Scotia)
name: Paul Hernandez, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CAAA University of British Columbia
name: Mark J. FitzGerald, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CAAA University of British Columbia
name: Donald Sin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: INUD McGill University Healty Center
name: Andrea Benedetti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CPVR Institut universitaire de cardiologie et de pneumologie de Québec
name: Yves Lacasse, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Pierre Ernst, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Harvey Coxson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CEAA University of Toronto
name: Roger Goldstein, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CAAA University of British Columbia
name: Carlo Marra, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moslemi A, Makimoto K, Tan WC, Bourbeau J, Hogg JC, Coxson HO, Kirby M; Canadian Cohort of Obstructive Lung Disease. Quantitative CT Lung Imaging and Machine Learning Improves Prediction of Emergency Room Visits and Hospitalizations in COPD. Acad Radiol. 2023 Apr;30(4):707-716. doi: 10.1016/j.acra.2022.05.009. Epub 2022 Jun 8.
citation: Phillips DB, Elbehairy AF, James MD, Vincent SG, Milne KM, de-Torres JP, Neder JA, Kirby M, Jensen D, Stickland MK, Guenette JA, Smith BM, Aaron SD, Tan WC, Bourbeau J, O'Donnell DE; CanCOLD Collaborative Research Group and the Canadian Respiratory Research Network. Impaired Ventilatory Efficiency, Dyspnea, and Exercise Intolerance in Chronic Obstructive Pulmonary Disease: Results from the CanCOLD Study. Am J Respir Crit Care Med. 2022 Jun 15;205(12):1391-1402. doi: 10.1164/rccm.202109-2171OC.
citation: Tan WC, Bourbeau J, Nadeau G, Wang W, Barnes N, Landis SH, Kirby M, Hogg JC, Sin DD; CanCOLD Collaborative Research Group; authors would also like to thank the men and women who participated in the study and individuals in the CanCOLD Collaborative Research Group not listed as authors:. High eosinophil counts predict decline in FEV1: results from the CanCOLD study. Eur Respir J. 2021 May 27;57(5):2000838. doi: 10.1183/13993003.00838-2020. Print 2021 May.
citation: Lewthwaite H, Elsewify O, Niro F, Bourbeau J, Guenette JA, Maltais F, Marciniuk DD, O'Donnell DE, Smith BM, Stickland MK, Tan WC, Jensen D; CanCOLD Collaborative Research Group; Canadian Respiratory Research Network. Normative Cardiopulmonary Exercise Test Responses at the Ventilatory Threshold in Canadian Adults 40 to 80 Years of Age. Chest. 2021 May;159(5):1922-1933. doi: 10.1016/j.chest.2020.11.009. Epub 2020 Nov 18.
citation: Barrecheguren M, Pinto L, Mostafavi-Pour-Manshadi SM, Tan WC, Li PZ, Aaron SD, Benedetti A, Chapman KR, Walker B, Fitzgerald JM, Hernandez P, Maltais F, Marciniuk DD, O'Donnell DE, Sin DD, Bourbeau J; CanCOLD Collaborative Research Group and the Canadian Respiratory Research Network. Identification and definition of asthma-COPD overlap: The CanCOLD study. Respirology. 2020 Aug;25(8):836-849. doi: 10.1111/resp.13780. Epub 2020 Feb 16.
citation: Gupta N, Pinto L, Benedetti A, Li PZ, Tan WC, Aaron SD, Chapman KR, FitzGerald JM, Hernandez P, Marciniuk DD, Maltais F, O'Donnell DE, Sin D, Walker BL, Bourbeau J; Canadian Respiratory Research Network and the CanCOLD Collaborative Research Group. The COPD Assessment Test: Can It Discriminate Across COPD Subpopulations? Chest. 2016 Nov;150(5):1069-1079. doi: 10.1016/j.chest.2016.06.016. Epub 2016 Jun 27.
citation: Tan WC, Sin DD, Bourbeau J, Hernandez P, Chapman KR, Cowie R, FitzGerald JM, Marciniuk DD, Maltais F, Buist AS, Road J, Hogg JC, Kirby M, Coxson H, Hague C, Leipsic J, O'Donnell DE, Aaron SD; CanCOLD Collaborative Research Group. Characteristics of COPD in never-smokers and ever-smokers in the general population: results from the CanCOLD study. Thorax. 2015 Sep;70(9):822-9. doi: 10.1136/thoraxjnl-2015-206938. Epub 2015 Jun 5.