COPDCAN-EXACTNCT07850648
The CANadian EXAcerbation of COPD Trial
An observational study of COPD and AECOPD, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- How many people
- 125 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2026to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
McGill University Health Centre, Montreal
Montreal, Quebec, H4A 3J1
Bryan A. Ross, (514) 843-1465, bryan.ross@mcgill.ca
About this study
Official title: The CANadian EXAcerbation of COPD Trial (CAN-EXACT)
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.
Read the detailed description
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.
The investigators 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.
- 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 24 months
Secondary outcomes (4)
Risk Factors Associated with COPD Exacerbations
Identifiable clinical, physiological, and environmental factors associated with exacerbation occurrence and frequency.
Measured: Baseline to 24 months
Current and Emerging COPD Exacerbation Interventions
Efficacy of the various observed interventions and healthcare resources used to treat exacerbations.
Measured: Baseline to 24 months
Mortality
Mortality (death) over the follow-up period, confirmed by chart review.
Measured: 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.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start28 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- DiaSorin Inc.
- Responsible party
- Principal investigator, Bryan A. Ross, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850648
- Sponsor's protocol ID
- 2026-12359
- Acronym
- CAN-EXACT
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CANadian EXAcerbation of COPD Trial (CAN-EXACT)
- ClinicalTrials.gov ID
- NCT07850648
- Acronym / sponsor ID
- CAN-EXACT / 2026-12359
- Keywords
- acute exacerbation of COPD (AECOPD), chronic obstructive pulmonary disease (COPD), remote patient monitoring, oscillometry, heart-lung interactions, type 2 inflammation, infection, imaging biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- DiaSorin Inc.
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The investigators 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COPD Exacerbations
Time frame: Baseline to 24 months
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.
Diagnostic Markers of COPD Exacerbations
Time frame: Baseline to 24 months
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.
4 secondary outcomes
Risk Factors Associated with COPD Exacerbations
Time frame: Baseline to 24 months
Current and Emerging COPD Exacerbation Interventions
Time frame: Baseline to 24 months
Mortality
Time frame: Baseline to 24 months
Health Economic Impact of COPD Exacerbations
Time frame: Baseline to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and AECOPD, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan A. Ross, MD, MSc (Physiol), MSc (Epi) ((514) 843-1465, bryan.ross@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Exacerbations (time frame: Baseline to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.