An observational study in COPD and AECOPD, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Not yet recruiting at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational
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 both of baseline clinical risk factors as well as for the deep phenotyping of each individual acute event.
The objective of the CAN-EXACT prospective observational cohort study is to collect multidimensional data along both chronic and acute phases of the disease in order to generate new evidence on the underlying mechanisms, diagnosis, monitoring and treatment of acute exacerbations, and thereby advance the standard of care in COPD.
We hypothesize that CAN-EXACT will generate novel insights that will help fill and address the pressing knowledge gaps and unmet needs pertaining to exacerbations of COPD.
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.
Exclusion Criteria:
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.
Time frame: Baseline to 24 months
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.
Time frame: Baseline to 24 months
Risk Factors Associated with COPD Exacerbations
Identifiable clinical, physiological, and environmental factors associated with exacerbation occurrence and frequency.
Time frame: Baseline to 24 months
Current and Emerging COPD Exacerbation Interventions
Efficacy of the various observed interventions and healthcare resources used to treat exacerbations.
Time frame: Baseline to 24 months
Health Economic Impact of COPD Exacerbations
Costs associated with exacerbations and with the various health care interventions and resources used to treat them.
Time frame: Baseline to 24 months
Plan to share: No — Due to data privacy regulations, individual participant data collected during this study is not publicly accessible. However, access to anonymized data may be granted upon evaluation by the trial management group. Additional documents will also be available upon inquiry. All requests should be directed to the corresponding author (BAR).
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
McGill University Health Centre/Research Institute of the McGill University Health Centre