About this trial
The natural history of Chronic Obstructive Pulmonary Disease (COPD) is marked by acute, episodic attacks known as exacerbations of COPD. These events are associated with increased systemic inflammation, lung function decline, hospitalization, and mortality. Despite their high clinical burden, the mechanisms underlying exacerbations, as well as effective approaches to their diagnosis, monitoring, and treatment, represent important unmet clinical care gaps.
CAN-EXACT is a prospective longitudinal observational cohort consisting of patient participants with moderate, severe, and very severe COPD with a history of frequent exacerbations. Participants undergo detailed clinical, physiological, imaging, and biological assessments at baseline and at a two-year follow-up visit. Every two weeks, participants complete self-reported symptom and exacerbation questionnaires and continuously wear a biometric wristband to remotely monitor respiratory, cardiac, sleep, physical activity, and autonomic parameters. When participants experience an exacerbation requiring in-person unscheduled acute care, several bedside tests and procedures are performed on each occasion. Biological samples, collected both at the baseline and the follow-up study visits as well as during each acute exacerbation requiring in-person care, are analyzed and are then transferred to a biobank.
This overall cohort design allows for both the comprehensive phenotyping of baseline clinical risk factors as well as for the deep phenotyping of each individual acute event.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females aged ≥40 years
Former or current smoker with a ≥10 pack-year history, or with a confirmed history of alpha-1 antitrypsin deficiency
Spirometry-confirmed COPD (FEV1/FVC < 0.7) and FEV1 < 80% of predicted
History of ≥2 COPD exacerbations in the past 12 months requiring systemic corticosteroids, antibiotics, or both
Disqualifiers
Inability to provide informed consent or to participate in study procedures
Any life-threatening condition, including but not limited to malignancy, that in the opinion of the investigator might prevent the participant from completing study visits
Currently being treated for an exacerbation and in the opinion of the investigator might be unable to complete study visits representative of the participant's clinical baseline
Trial population
Subjects will be recruited from respiratory clinics and urgent care settings at the McGill University Health Centre, Montreal, Quebec, Canada. Potential participants will be asked by their treating clinical team if they can be contacted for possible participation in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
COPD Exacerbations
COPD exacerbations, acute events with symptom worsening and characterized by increased dyspnea and/or cough and sputum that is often associated with increased local and systemic inflammation, will be ascertained through biweekly participant-reported questionnaires and medical records. Exacerbations represent the primary outcome of CAN-EXACT and will be summarized as the rate per participant-year and will be classified by severity.
Diagnostic Markers of COPD Exacerbations
Markers for the diagnosis, monitoring and prediction of COPD exacerbations, derived from clinical assessment, point-of-care testing, patient-reported outcomes, and continuous remote monitoring.
Secondary outcomes
Risk Factors Associated with COPD Exacerbations
Identifiable clinical, physiological, and environmental factors associated with exacerbation occurrence and frequency.
Current and Emerging COPD Exacerbation Interventions
Efficacy of the various observed interventions and healthcare resources used to treat exacerbations.
Mortality
Mortality (death) over the follow-up period, confirmed by chart review.
Health Economic Impact of COPD Exacerbations
Costs associated with exacerbations and with the various health care interventions and resources used to treat them.
Sponsors and contacts
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