The Canadian Cohort Obstructive Lung Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— CanCOLD  

Official title:

The Canadian Cohort Obstructive Lung Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00920348
• Other study ID #: IRO-93326
• Status: Active, not recruiting
• Start date: January 2010
• Est. completion date: December 2022

Study information

• Verified date: August 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Calgary	Alberta
Canada	Halifax Infirmary	Halifax	Nova Scotia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Montreal Chest Institute	Montreal	Quebec
Canada	Ottawa Hospital General	Ottawa	Ontario
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	University of Toronto	Toronto	Ontario
Canada	St-Paul's Hospital	Vancouver	British Columbia

Sponsors (10)

Lead Sponsor	Collaborator
McGill University Health Center	Almirall, SAS, AstraZeneca, Boehringer Ingelheim, Canadian Institutes of Health Research (CIHR), GlaxoSmithKline, Merck Sharp & Dohme Corp., Novartis, Pfizer, Takeda

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What risk factors other than smoking determine the development and progression of COPD.		One visit a year every 18 months
Secondary	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)		One visit a year 18 months
Secondary	Is early detection of COPD with spirometry meaningful according to sex and ageing.		One visit a year 18 months