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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04105088
Other study ID # ASB-2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 13, 2018
Est. completion date March 31, 2026

Study information

Verified date January 2024
Source University of British Columbia
Contact Pat G Camp, PhD
Phone 604-806-9144
Email pat.camp@hli.ubc.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background. First Nations peoples in Canada carry an increased respiratory health burden compared to non-First Nations. However, there is little accurate information of how many First Nations people have COPD, especially in remote and rural areas. Goal & Aims of the Study. The goal of this study is to estimate the burden of COPD in remote and rural First Nations communities. This project is a partnership between the University of British Columbia (UBC), Carrier Sekani Family Services (CSFS), and 13 First Nations communities in northern BC. Aim 1: Estimate the prevalence of COPD and the magnitude of underdiagnosis. Aim 2: Characterize the relationship between inhaled pollutants (from residential, occupational, and community/cultural sources) and: 1) symptoms; 2) airflow obstruction; and 3) health care utilization. Methodology. The investigators will recruit adults from randomly-selected households in 13 First Nations communities in northern BC. Detailed measurements of lung function, symptoms, self-reported exposure to lung irritants, air quality, and healthcare use will be collected. Expected Outcomes. This study will provide an accurate estimate of the prevalence of COPD and, using a culturally-relevant community-based research approach, will identify the contribution of risk factors to COPD in First Nations communities.


Description:

Background. First Nations peoples in Canada carry an increased respiratory health burden compared to non-First Nations. They are often exposed to high rates of indoor air pollution and cigarette smoke; and although there is a high use of acute health care services for chronic obstructive pulmonary disease (COPD), this disease is not "on the radar" in many First Nations communities. This may be because there is little accurate information of how many First Nations people have COPD, especially in remote and rural areas. The current estimates of prevalence of COPD in First Nations are based on self-report surveys, which are known to underestimate the true number threefold. Although it is well-known that cigarette smoking causes COPD, there has been less attention paid to the contribution of residential, historical/community/cultural, and occupational factors to the burden of COPD in First Nations people. Goal & Aims of the Study. The goal of this study is to estimate the burden of COPD in remote and rural First Nations communities. This project is a partnership between the University of British Columbia (UBC), Carrier Sekani Family Services (CSFS), and 13 First Nations communities in northern BC. Aim 1: Estimate the prevalence of COPD and the magnitude of underdiagnosis. Aim 2: Characterize the relationship between inhaled pollutants (from residential, occupational, and community/cultural sources) and: 1) symptoms; 2) airflow obstruction; and; 3) health care utilization. The Primary Outcome is the prevalence of COPD. Methodology. The investigators will recruit adults from randomly-selected households in 13 First Nations communities in northern BC. The investigators will collect detailed measurements of lung function, symptoms, self-reported exposure to lung irritants, and healthcare use. The investigators will also collect indoor air quality measures from homes and community buildings. For Aim 1, the prevalence and underdiagnosis of COPD will be estimated by measuring lung function using post-bronchodilator spirometry and comparing the presence of airflow obstruction with the diagnosis of COPD in the electronic health record. For Aim 2, the investigators will explore the relationship between inhaled indoor air pollutants and 1) current cough, wheeze, and dyspnea; 2) airflow obstruction; and 3) respiratory-related primary care visits or hospitalization, adjusting for age, sex, and smoking history. Expected Outcomes. This study will provide an accurate estimate of the prevalence of COPD and, using a culturally-relevant community-based research approach, will identify the contribution of risk factors to COPD in First Nations communities. The Primary Outcome is the prevalence of COPD. Significance of this Project. This project is a novel partnership between UBC, CSFS and partner Nations to explore the prevalence and risk factors of COPD, using a Indigenous approach to health research. This study is unique in being able to address the risks of COPD in remote and rural First Nations communities, which will lead to further work to identify strategies to reduce these risks and improve lung health.


Recruitment information / eligibility

Status Recruiting
Enrollment 325
Est. completion date March 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: - 30 years and older - living in one of participating First Nations communities Exclusion Criteria: - confusion, dementia

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada 13 individual First Nations in north-Central BC near Prince George, BC Prince George British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Carrier Sekani Family Services

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary forced expiratory volume, 1st second in litres pre- and post-bronchodilator FEV1 to determine reversibility of airflow obstruction measured at study recruitment
Primary forced vital capacity in litres pre- and post-bronchodilator measures of vital capacity for use in the diagnosis of COPD measured at study recruitment
Primary FEV1/FVC ratio pre- and post-bronchodilator measures of FEV1/FVC to confirm diagnosis of COPD (where the FEV1 to FVC <0.70) measured at study recruitment
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