Clinical trial NCT02153684: Canadian Cohort on the Origin and Progression of Airway Disease: Physiology Platform
Official title: Canadian Cohort on the Origin and Progression of Airway Disease: Physiology Platform
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
COPD
Keywords: smoking
small airway dysfunction
mild COPD
dyspnea
exercise
clinical outcomes
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Ottawa Hospital Research Institute
name: University of British Columbia
name: McGill University
First posted: 2014-06-03
Enrollment: 99
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will include 30 participants from each of the following four subgroups: GOLD grade 1A COPD, GOLD grade 1B COPD, symptomatic smokers who do not meet spirometric criteria for COPD, and age- and sex-matched healthy non-smoking controls. Subjects will be recruited from the Canadian Chronic Obstructive Lung Disease (CanCOLD) study cohort and, once that source has been exhausted, from each site's database of previous or potential research study participants. The CanCOLD Study cohort was recruited from the COLD Study sample, which was a random sample of adults ≥40 years of age who had pre- and post-bronchodilator spirometry performed in order to estimate the prevalence of COPD in Canada.

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.


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.

Primary outcomes:
measure: Small airway function
timeFrame: 1 day (Time of visit)
Secondary outcomes:
measure: Cardiopulmonary exercise test
timeFrame: 1 day (Time of visit)
measure: Clinical outcome
timeFrame: 1 day (Time of visit)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Kingston
country: Canada
facility: Queen's University and Kingston General Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Queen's University and Kingston General Hospital
name: Denis E O'Donnell, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: