Chronic Obstructive Pulmonary Disease Biomarker Study
Chronic Obstructive Pulmonary Disease Biomarker Study
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.
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.
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