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

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ClinicalTrials.gov Identifier: NCT02153684
Recruitment Status : Recruiting
First Posted : June 3, 2014
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
University of British Columbia
McGill University
Information provided by (Responsible Party):
Dr. Denis O'Donnell, Queen's University

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.

Condition or disease
Smoking COPD

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Canadian Cohort on the Origin and Progression of Airway Disease: Physiology Platform
Study Start Date : March 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Group/Cohort
Mild COPD, symptomatic
Smokers fitting GOLD 1B criteria for COPD
Mild COPD, asymptomatic
Smokers fitting GOLD 1A criteria for COPD
Symptomatic smokers, at risk for COPD
Smokers who do not meet spirometric criteria for COPD
Healthy, non-smoking controls
Non-smokers, matched to smoking groups for age (>40 yrs of age) and gender



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Clinical outcome [ Time Frame: 1 day (Time of visit) ]
    Includes questionnaires regarding chronic activity-related dyspnea, respiratory symptoms, health status and physical activity.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153684


Contacts
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Contact: Denis O'Donnell, MD, FRCPC 613-548-2339 odonnell@queensu.ca
Contact: Sandra Vincent 613-549-6666 ext 4890 vincents@queensu.ca

Locations
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Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Principal Investigator: Jordan A Guenette, Ph.D.         
Canada, Ontario
Queen's University and Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Principal Investigator: Denis E O'Donnell, MD, FRCPC         
Sub-Investigator: J. Alberto Neder, MD         
Canada, Quebec
McGill University Recruiting
Montreal, Quebec, Canada, H2W 1S4
Principal Investigator: Dennis Jensen, Ph.D.         
Sponsors and Collaborators
Queen's University
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
University of British Columbia
McGill University
Investigators
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Principal Investigator: Denis E O'Donnell, MD, FRCPC Queen's University and Kingston General Hospital

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Responsible Party: Dr. Denis O'Donnell, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT02153684     History of Changes
Other Study ID Numbers: DMED-1674-14
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Keywords provided by Dr. Denis O'Donnell, Queen's University:
smoking
small airway dysfunction
mild COPD
dyspnea
exercise
clinical outcomes
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes