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The CANadian EXAcerbation of COPD Trial

Study acronym: CAN-EXACT
StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Secondary endpoints: 3 to 4
    • Study description expanded, about 1 word
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07850648
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: DiaSorin Inc.
Conditions
(from sponsor)
COPD, AECOPD
Related terms Infections, Pulmonary Disease, Chronic Obstructive
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov