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

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.

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Key information

Conditions

Smoking Behavior COPD Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Small airway function

Time frame: 1 day (Time of visit)

There is no single measurement of small airway function since this study is evaluating which measurements, among a list of conventional and experimental physiological parameters, best characterize the nature and extent of impairment of respiratory function in the smoking study groups and which of these parameters best predict clinical outcome (i.e., dyspnea, exercise capacity, ventilatory capacity, health status). Assessments will include: spirometry, closing volume, impulse oscillometry, frequency dependence of dynamic lung compliance, plethysmographic lung volumes and metronome-paced dynamic hyperinflation.

Secondary outcomes

Cardiopulmonary exercise test

Time frame: 1 day (Time of visit)

Includes measurements of exertional dyspnea (intensity and quality), peak exercise capacity (peak oxygen uptake [VO2]) and ventilatory responses (ventilation, pulmonary gas exchange, breathing pattern, operating lung volumes and tidal flow-volume loops) during symptom-limited incremental cardiopulmonary cycle exercise testing.
Clinical outcome

Time frame: 1 day (Time of visit)

Includes questionnaires regarding chronic activity-related dyspnea, respiratory symptoms, health status and physical activity.

Sponsors and collaborators

Lead sponsor

Dr. Denis O'Donnell

Other

Collaborators

Canadian Institutes of Health Research (CIHR)
McGill University
Ottawa Hospital Research Institute
University of British Columbia

Registry information

Important dates

Study start: 2015
Primary completion: 2022
Study completion: 2022
First posted: Jun 3, 2014
Registry last updated: Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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