NCT02050022|Unknown
Chronic Obstructive Pulmonary Disease Biomarker Study
Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for Chronic Obstructive Pulmonary Disease Management
Loading search results
Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for Chronic Obstructive Pulmonary Disease Management
Sponsor study identifier
observational
522
1 country
1
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2017
Actual (reported)Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 28, 2014
Actual (reported)January 30, 2014
Actual (reported)December 2017
Actual (reported)December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Exacerbation
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
Patients experiencing acute exacerbation of COPD.
COPD patients not experiencing acute exacerbation of COPD.
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.
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
Bafadhel M, McKenna S, Terry S, Mistry V, Reid C, Haldar P, McCormick M, Haldar K, Kebadze T, Duvoix A, Lindblad K, Patel H, Rugman P, Dodson P, Jenkins M, Saunders M, Newbold P, Green RH, Venge P, Lomas DA, Barer MR, Johnston SL, Pavord ID, Brightling CE. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med. 2011 Sep 15;184(6):662-71. doi: 10.1164/rccm.201104-0597OC.
Plasma, serum, whole blood, sputum
Donald D Sin, MD, MPH
University of British Columbia, St. Paul's Hospital, James Hogg Research Centre
522 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2014
First Posted
January 30, 2014
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Educational Interventions for Chronic Obstructive Pulmonary Disease (COPD) Self-management in Ethno-cultural Communities
Contact the study team to confirm eligibility.
Aaron SD, Donaldson GC, Whitmore GA, Hurst JR, Ramsay T, Wedzicha JA. Time course and pattern of COPD exacerbation onset. Thorax. 2012 Mar;67(3):238-43. doi: 10.1136/thoraxjnl-2011-200768. Epub 2011 Oct 18.
Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1298-303. doi: 10.1164/rccm.200310-1443OC. Epub 2004 Feb 27.
Sin DD, Man SF. Inhaled corticosteroids and survival in chronic obstructive pulmonary disease: does the dose matter? Eur Respir J. 2003 Feb;21(2):260-6. doi: 10.1183/09031936.03.00040803.
Sanchez M, Vellanky S, Herring J, Liang J, Jia H. Variations in Canadian rates of hospitalization for ambulatory care sensitive conditions. Healthc Q. 2008;11(4):20-2. doi: 10.12927/hcq.2008.20087. No abstract available.
Chapman KR, Bourbeau J, Rance L. The burden of COPD in Canada: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S23-31. doi: 10.1016/s0954-6111(03)80022-7.
Mittmann N, Kuramoto L, Seung SJ, Haddon JM, Bradley-Kennedy C, Fitzgerald JM. The cost of moderate and severe COPD exacerbations to the Canadian healthcare system. Respir Med. 2008 Mar;102(3):413-21. doi: 10.1016/j.rmed.2007.10.010. Epub 2007 Dec 20.
Sin DD, McAlister FA, Man SF, Anthonisen NR. Contemporary management of chronic obstructive pulmonary disease: scientific review. JAMA. 2003 Nov 5;290(17):2301-12. doi: 10.1001/jama.290.17.2301.
Malhotra S, Man SF, Sin DD. Emerging drugs for the treatment of chronic obstructive pulmonary disease. Expert Opin Emerg Drugs. 2006 May;11(2):275-91. doi: 10.1517/14728214.11.2.275.
Vestbo J, Anderson W, Coxson HO, Crim C, Dawber F, Edwards L, Hagan G, Knobil K, Lomas DA, MacNee W, Silverman EK, Tal-Singer R; ECLIPSE investigators. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE). Eur Respir J. 2008 Apr;31(4):869-73. doi: 10.1183/09031936.00111707. Epub 2008 Jan 23.
Freue GV, Sasaki M, Meredith A, Gunther OP, Bergman A, Takhar M, Mui A, Balshaw RF, Ng RT, Opushneva N, Hollander Z, Li G, Borchers CH, Wilson-McManus J, McManus BM, Keown PA, McMaster WR; Genome Canada Biomarkers in Transplantation Group. Proteomic signatures in plasma during early acute renal allograft rejection. Mol Cell Proteomics. 2010 Sep;9(9):1954-67. doi: 10.1074/mcp.M110.000554. Epub 2010 May 25.
Gunther OP, Balshaw RF, Scherer A, Hollander Z, Mui A, Triche TJ, Freue GC, Li G, Ng RT, Wilson-McManus J, McMaster WR, McManus BM, Keown PA; Biomarkers in Transplantation Team. Functional genomic analysis of peripheral blood during early acute renal allograft rejection. Transplantation. 2009 Oct 15;88(7):942-51. doi: 10.1097/TP.0b013e3181b7ccc6.
Lin D, Hollander Z, Ng RT, Imai C, Ignaszewski A, Balshaw R, Freue GC, Wilson-McManus JE, Qasimi P, Meredith A, Mui A, Triche T, McMaster R, Keown PA, McManus BM; Biomarkers in Transplantation Team; NCE CECR Centre of Excellence for the Prevention of Organ Failure. Whole blood genomic biomarkers of acute cardiac allograft rejection. J Heart Lung Transplant. 2009 Sep;28(9):927-35. doi: 10.1016/j.healun.2009.04.025.
Kuzyk MA, Smith D, Yang J, Cross TJ, Jackson AM, Hardie DB, Anderson NL, Borchers CH. Multiple reaction monitoring-based, multiplexed, absolute quantitation of 45 proteins in human plasma. Mol Cell Proteomics. 2009 Aug;8(8):1860-77. doi: 10.1074/mcp.M800540-MCP200. Epub 2009 May 1.
Lee H, Kovacs C, Mattman A, Hollander Z, Chen V, Ng R, Leung JM, Sin DD. The impact of IgG subclass deficiency on the risk of mortality in hospitalized patients with COPD. Respir Res. 2022 May 31;23(1):141. doi: 10.1186/s12931-022-02052-3.
Takiguchi H, Chen V, Obeidat M, Hollander Z, FitzGerald JM, McManus BM, Ng RT, Sin DD. Effect of short-term oral prednisone therapy on blood gene expression: a randomised controlled clinical trial. Respir Res. 2019 Aug 5;20(1):176. doi: 10.1186/s12931-019-1147-2.
Primary Completion
December 2017
Actual (reported)Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 30, 2021
Record last verified: 2021-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: