The CANadian EXAcerbation of COPD Trial

NCT07850648 | Not Yet Recruiting

• 1 other identifier: 2026-12359
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD; AECOPD

Keywords

acute exacerbation of COPD (AECOPD); chronic obstructive pulmonary disease (COPD); remote patient monitoring; oscillometry; heart-lung interactions; type 2 inflammation; infection; imaging biomarkers; clinical exercise testing; patient-reported outcomes; biobank; ambient air pollution; mechanism; immunology; health economic evaluation; non-type 2 inflammation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to 24 months

Secondary Outcomes (3)

• Risk Factors Associated with COPD Exacerbations

  Baseline to 24 months

• Current and Emerging COPD Exacerbation Interventions

  Baseline to 24 months

• Health Economic Impact of COPD Exacerbations

  Baseline to 24 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DiaSorin Inc.: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre, Montreal

Montreal, Quebec, H4A 3J1, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples to measure a broad range of biomarkers: * Cardiac markers * Inflammatory markers * Immunological markers * Infection markers * Acid-base status * Alpha-1-antitrypsin deficiency Sputum samples to measure a broad range of microbiological and inflammatory parameters: * Bacterial culture * Inflammatory markers * Immunological markers * Microbes

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Infections

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bryan A. Ross, MD, MSc (Physiol), MSc (Epi)

CONTACT

(514) 843-1465; bryan.ross@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist (RI-MUHC), Respirologist (MUHC), Assistant Professor (McGill University)

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)