The CANadian EXAcerbation of COPD 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 both of baseline clinical risk factors as well as for the deep phenotyping of each individual acute event.

Inclusion Criteria: * 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 * Capacity to access internet at regular intervals Exclusion Criteria: * 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