Canadian Cohort on the Origin and Progression of Airway Disease: Physiology Platform

NCT ID: NCT02153684

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 99 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2022-09-30

Brief Summary

The Canadian Respiratory Research Network (CRRN) has recently been established to study the origins and evolution of airways disease in the population. The CRRN is funded by the Institute of Cardio-respiratory Health (ICRH), an institute of the CIHR. The Physiology platform will support the other CRRN platforms (biology, imaging, population health, knowledge transfer) by providing a comprehensive characterization of the nature and extent of physiological impairment of respiratory function in smokers at risk for airways disease and in those with early or mild airway obstruction. The planned studies of the physiology group (core sites located at Queen's University, University of British Columbia and McGill University) will initially focus on smoking-related lung injury in those at risk for COPD and in those meeting spirometric criteria for mild airway obstruction, with or without respiratory symptoms. The primary aim of this initial study is to identify and validate sensitive test(s) of peripheral airway dysfunction that may qualify as physiological biomarkers for use in future CRRN studies.

Conditions

Smoking; COPD

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Mild COPD, symptomatic

Smokers fitting GOLD 1B criteria for COPD

No interventions assigned to this group

Mild COPD, asymptomatic

Smokers fitting GOLD 1A criteria for COPD

No interventions assigned to this group

Symptomatic smokers, at risk for COPD

Smokers who do not meet spirometric criteria for COPD

No interventions assigned to this group

Healthy, non-smoking controls

Non-smokers, matched to smoking groups for age (\>40 yrs of age) and gender

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Stable patients with GOLD grade 1 mild COPD will be included in the study if they have: a post-bronchodilator FEV1≥80 %predicted and an FEV1/FVC ratio <0.7 and <LLN; ≥40 years of age; and a cigarette smoking history ≥10 pack-years or ≥10 years of exposure to other inhaled substances (i.e., second hand smoke and/or biomass). Symptomatic (category B) subjects will have a Baseline Dyspnea Index (BDI) total score ≤9, a modified Medical Research Council (MRC) dyspnea score ≥2, or a COPD Assessment Test (CAT) score ≥10. Asymptomatic (category A) subjects will have a BDI>9, modified MRC<2 or CAT<10, no history of seeking medical care for respiratory symptoms, and no history of using respiratory medications. Symptomatic current or ex-smokers (>10 pack-year history) who do not meet criteria for COPD (e.g., post-bronchodilator FEV1<80%predicted and FEV1/FVC<0.7, with both measurements also <LLN) and who are on no respiratory medication will be included. Symptomatic will be defined as: BDI≤9, modified MRC≥2 or CAT>10. Healthy, age- and sex-matched, non-smoking (<2 pack-year history) participants with normal spirometry will be used for comparison purposes.

Exclusion Criteria

• presence of clinically significant comorbidities that could contribute to dyspnea or exercise limitation (i.e., unstable heart disease, a pulmonary disease other than COPD, uncontrolled diabetes, neuromuscular or orthopedic impairment);
• history/clinical evidence of asthma;
• contraindications to exercise testing;
• <40 years of age;
• body mass index <18.5 or >=35 kg/m2.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

Dr. Denis O'Donnell

OTHER

Sponsor Role: lead

Responsible Party

Dr. Denis O'Donnell

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Denis E O'Donnell, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University and Kingston General Hospital

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Queen's University and Kingston General Hospital

Kingston, Ontario, Canada

McGill University

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

DMED-1674-14

Identifier Type: -

Identifier Source: org_study_id