The CANadian EXAcerbation of COPD Trial

ConditionsCOPDAECOPD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

Risk Factors Associated with COPD Exacerbations

Identifiable clinical, physiological, and environmental factors associated with exacerbation occurrence and frequency.

Time frame
Baseline to 24 months
2

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
3

Mortality

Mortality (death) over the follow-up period, confirmed by chart review.

Time frame
Baseline to 24 months
4

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

Other outcomes

Sponsors and contacts

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