Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Obstructive Pulmonary Disease Biomarker Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02050022
Recruitment Status : Unknown
Verified May 2017 by Don Sin, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : January 30, 2014
Last Update Posted : May 31, 2017
Sponsor:
Collaborators:
Genome British Columbia
Centres of Excellence for Commercialization and Research
Canadian Institutes of Health Research (CIHR)
Genome Quebec
Providence Health & Services
St. Paul's Hospital, Canada
Information provided by (Responsible Party):
Don Sin, University of British Columbia

Brief Summary:

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.


Condition or disease
Chronic Obstructive Pulmonary Disease

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for Chronic Obstructive Pulmonary Disease Management
Study Start Date : April 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Plasma, serum, whole blood, sputum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050022


Contacts
Layout table for location contacts
Contact: Sara Assadian, BA, CCRP 604-682-2344 ext 62557 sassadian@providencehealth.bc.ca
Contact: Zsuzsanna Hollander, PHD 604-682-2344 ext 62751 zsuzsanna.hollander@hli.ubc.ca

Locations
Layout table for location information
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Sara Assadian, BA, CCRP    604-682-2344 ext 62557    sassadian@providencehealth.bc.ca   
Principal Investigator: Donald D Sin, MD, MPH         
Sponsors and Collaborators
University of British Columbia
Genome British Columbia
Centres of Excellence for Commercialization and Research
Canadian Institutes of Health Research (CIHR)
Genome Quebec
Providence Health & Services
St. Paul's Hospital, Canada
Investigators
Layout table for investigator information
Principal Investigator: Donald D Sin, MD, MPH University of British Columbia, St. Paul's Hospital, James Hogg Research Centre

Publications:

Layout table for additonal information
Responsible Party: Don Sin, Dr. Don Sin, University of British Columbia
ClinicalTrials.gov Identifier: NCT02050022     History of Changes
Other Study ID Numbers: H11-00786
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Don Sin, University of British Columbia:
Biomarkers
Genomics
Proteomics
Diagnostics
Prognostics

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases