Chronic Obstructive Pulmonary Disease Biomarker Study

April 28, 2021 updated by: Don Sin, University of British Columbia

Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for Chronic Obstructive Pulmonary Disease Management

Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease that is characterized by loss of lung function, leading to breathlessness, poor quality of life, loss in productivity, and increased mortality. The World Health Organization estimates that COPD will be the third leading cause of death worldwide by 2020, accounting for more than 7 million deaths annually. COPD patients frequently experience 'lung attacks', during which breathlessness, coughing, and sputum production dramatically increase, leading to urgent office visits, emergency admissions and hospitalizations. Lung attacks reduce patient quality of life and cost the Canadian health care system nearly $4 billion dollars each year in direct and indirect costs. Lung attacks can be effectively managed if they are identified and treated early, but symptoms of a lung attack often overlap with those of other common conditions such as heart failure, pneumonia and even influenza. Because there are no tests that can separate lung attacks from these conditions, doctors struggle to accurately diagnose lung attacks at an early stage when drugs are most effective. This can lead to a delayed or even incorrect diagnosis and inappropriate treatment. This research will address this critical need. Our goal is to improve COPD patient care by developing new blood tests that will help identify patients who are in the early stages of a lung attack. Doctors will be able to use these tests to treat lung attacks at earlier stages than is currently possible. These blood tests will enable doctors to personalize management of COPD to meet the needs of the individual patient.

Hypothesis: New biomarker blood tests can be used to better identify and manage patients with COPD.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

An acute exacerbation of COPD (AECOPD) is defined as an acute event characterized by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication (in most cases to antibiotics and/or oral corticosteroids). In most cases of AECOPD, patients experience a gradual crescendo-like increase in shortness of breath, cough and purulent sputum production over days to weeks. At their peak, patients may experience extreme shortness of breath (sometimes described as "breathless paralysis") and uncontrollable paroxysms of cough and purulent sputum production. AECOPDs are complex physiological events. In 70-80% of cases, AECOPDs are precipitated by bacterial or viral respiratory tract infections. However, most patients who develop acute symptoms (e.g., runny nose, cough or fever) do not progress to AECOPDs and experience spontaneous resolution of their symptoms. Furthermore, many patients with COPD who do harbour pathogenic organisms in their airways do not develop AECOPD symptoms. Thus, other factors, including the host inflammatory response, likely play a role in the pathogenesis of AECOPDs. Prompt recognition and treatment of AECOPD during this prodromal period can abrogate full blown attacks. Thus by identifying and treating AECOPDs early on (in physicians' offices), emergency visits, hospitalizations, and even deaths can be significantly reduced. However, this is not easy as symptoms of AECOPD (especially early in their course) are non-specific and can easily be confused with other ailments such as heart failure, allergies, or even upper respiratory tract infections. Since there are no biochemical tests that clinicians can order to objectively confirm AECOPD, AECOPD can be missed entirely or misdiagnosed, leading to delayed treatments or in some cases to the wrong treatment, which may result in devastating consequences including respiratory failure, hospitalizations or even death. Once patients are in the full blown attack stage of AECOPD, treatments are only modestly helpful in relieving symptoms and hospitalization is often required to resolve them. The median duration of hospitalization for AECOPD in Canada is 10 days, followed by an average of 3 months of convalescence. Unfortunately, in most cases, full recovery is never achieved and patients continue to experience rapid decline in lung and physical function (compared to patients not hospitalized for AECOPD). The 3 year mortality rate following hospitalization is 50%, and hospitalizations and emergency visits are avoidable with earlier detection, diagnosis and treatment of AECOPD. Indeed, COPD is the leading cause of preventable hospitalization in Canada. However, without a simple blood test that primary care physicians (PCPs) can order in their offices, earlier diagnosis will not be feasible.

The primary objective of this study is to identify blood biomarkers that can diagnose AECOPD.

Following informed consent, blood samples will be collected from patients who are admitted for an exacerbation at day 1, 3 and 7 of their hospitalization and then at 30 days and 90 days post-hospitalization. Sputum samples will also be collected on the day of admission for AECOPD etiologic phenotyping. All patients receive standard anti-exacerbation care in hospital, including systemic corticosteroids and antibiotics and are followed both in and out of hospital by a transition team consisting of a nurse, physiotherapist and respiratory therapist with special expertise in COPD care.

Following informed consent of non-exacerbating patients, a blood sample will be collected which will be used as a comparison to the exacerbating patient samples.

Study Type

Observational

Enrollment (Actual)

522

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Exacerbation cohort: COPD patients who present in emergency or are admitted to Vancouver General Hospital or St. Paul's Hospital in Vancouver for a COPD exacerbation are approached for participation in the study.

Non-exacerbation cohort: COPD patients who are seen in the hospital COPD clinic and are not experiencing an exacerbation are approached for participation in the study.

Description

Inclusion Criteria:

  • 19 years of age or older
  • diagnosis of COPD
  • patients admitted to the hospital for a COPD exacerbation OR attending the COPD clinic and not experiencing a COPD exacerbation

Exclusion Criteria:

  • under 19 years of age
  • patients seen in the COPD clinic who are experiencing an exacerbation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Exacerbation
Patients experiencing acute exacerbation of COPD.
Non-Exacerbation
COPD patients not experiencing acute exacerbation of COPD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exacerbation
Time Frame: Within 1 year
Hospitalized and non-hospitalized exacerbations occurring within 1 year of hospital discharge from index hospitalization will be recorded. Non-hospitalized exacerbations will be defined by treatment with prednisone plus/minus antibiotics. Hospitalized exacerbations will be defined as a diagnosis of acute exacerbation of COPD at admission or at presentation to emergency.
Within 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)
St. Paul's Hospital, Canada
Providence Health & Services
Genome British Columbia
Genome Quebec
Centres of Excellence for Commercialization and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (ESTIMATE)

January 30, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H11-00786

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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