Characteristics That Identify Exacerbation Risk Following Colds in COPD Patients
Biomarkers and Clinical Characteristics That Identify the Risk of an Exacerbation Following Viral Upper Respiratory Tract Infections in COPD Patients
Biomarkers and Clinical Characteristics That Identify the Risk of an Exacerbation Following Viral Upper Respiratory Tract Infections in COPD Patients
Sponsor study identifier
observational
35
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Respiratory virus infections are a common cause of COPD exacerbations and antiviral therapies have potential as treatments for exacerbations. However it is likely that treating patients when they present with an exacerbation with antiviral drugs will be too late to be effective and earlier treatment at the time of the initial upper respiratory tract infection (URTI) will be required. The incidence of exacerbations following URTIs in COPD patients, and whether there are host factors and biomarkers that can identify the risk of this, is unknown. The aims of this study are to establish the proportion of viral URTIs that progress to an acute exacerbation in COPD patients and identify clinical, viral and biological markers that predict risk of an exacerbation following an URTI. In addition we will determine the frequency of, and risk factors for, bacterial infection following viral URTIs in COPD patients. This data will permit development of a model combining baseline patient characteristics, clinical measurements and biomarkers to predict exacerbation risk following viral URTI in COPD patients. The results will open the way for trials of antiviral therapy in COPD exacerbations and targeting of treatment to high risk patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Actual (reported)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.
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 17, 2011
Actual (reported)June 20, 2011
Actual (reported)June 2013
Actual (reported)June 2013
Actual (reported)Proportion of colds followed by exacerbations in COPD patients
2 years
Clinical characteristics that identify high risk of exacerbation following a cold in COPD patients
2 years
Biomarkers that identify the risk of exacerbation following colds in COPD patients
2 years
Changes in bacterial flora following colds in COPD patients
2 years
COPD patients
Imperial College
London, W2 1PG, United Kingdom
Seemungal T, Harper-Owen R, Bhowmik A, Moric I, Sanderson G, Message S, Maccallum P, Meade TW, Jeffries DJ, Johnston SL, Wedzicha JA. Respiratory viruses, symptoms, and inflammatory markers in acute exacerbations and stable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1618-23. doi: 10.1164/ajrccm.164.9.2105011.
Papi A, Bellettato CM, Braccioni F, Romagnoli M, Casolari P, Caramori G, Fabbri LM, Johnston SL. Infections and airway inflammation in chronic obstructive pulmonary disease severe exacerbations. Am J Respir Crit Care Med. 2006 May 15;173(10):1114-21. doi: 10.1164/rccm.200506-859OC. Epub 2006 Feb 16.
Sputum,nasal lavage, serum
Patrick Mallia, MD, PhD
Imperial College London
35 participants (actual enrollment reported by the registry).
First Submitted
June 17, 2011
First Posted
June 20, 2011
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Inhaled Mannitol and Ciliary Beat Frequency in COPD Patients
Contact the study team to confirm eligibility.
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Stolz D, Christ-Crain M, Morgenthaler NG, Leuppi J, Miedinger D, Bingisser R, Muller C, Struck J, Muller B, Tamm M. Copeptin, C-reactive protein, and procalcitonin as prognostic biomarkers in acute exacerbation of COPD. Chest. 2007 Apr;131(4):1058-67. doi: 10.1378/chest.06-2336.
Bozinovski S, Hutchinson A, Thompson M, Macgregor L, Black J, Giannakis E, Karlsson AS, Silvestrini R, Smallwood D, Vlahos R, Irving LB, Anderson GP. Serum amyloid a is a biomarker of acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2008 Feb 1;177(3):269-78. doi: 10.1164/rccm.200705-678OC. Epub 2007 Nov 15.
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Ip M, Rainer TH, Lee N, Chan C, Chau SS, Leung W, Leung MF, Tam TK, Antonio GE, Lui G, Lau TK, Hui DS, Fuchs D, Renneberg R, Chan PK. Value of serum procalcitonin, neopterin, and C-reactive protein in differentiating bacterial from viral etiologies in patients presenting with lower respiratory tract infections. Diagn Microbiol Infect Dis. 2007 Oct;59(2):131-6. doi: 10.1016/j.diagmicrobio.2007.04.019. Epub 2007 Jul 26.
Rainer TH, Chan CP, Leung MF, Leung W, Ip M, Lee N, Cautherley GW, Graham CA, Fuchs D, Renneberg R. Diagnostic utility of CRP to neopterin ratio in patients with acute respiratory tract infections. J Infect. 2009 Feb;58(2):123-30. doi: 10.1016/j.jinf.2008.11.007. Epub 2008 Dec 13.
Stolz D, Christ-Crain M, Bingisser R, Leuppi J, Miedinger D, Muller C, Huber P, Muller B, Tamm M. Antibiotic treatment of exacerbations of COPD: a randomized, controlled trial comparing procalcitonin-guidance with standard therapy. Chest. 2007 Jan;131(1):9-19. doi: 10.1378/chest.06-1500.
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Walter MJ, Castro M, Kunselman SJ, Chinchilli VM, Reno M, Ramkumar TP, Avila PC, Boushey HA, Ameredes BT, Bleecker ER, Calhoun WJ, Cherniack RM, Craig TJ, Denlinger LC, Israel E, Fahy JV, Jarjour NN, Kraft M, Lazarus SC, Lemanske RF Jr, Martin RJ, Peters SP, Ramsdell JW, Sorkness CA, Sutherland ER, Szefler SJ, Wasserman SI, Wechsler ME; National Heart, Lung and Blood Institute's Asthma Clinical Research Network. Predicting worsening asthma control following the common cold. Eur Respir J. 2008 Dec;32(6):1548-54. doi: 10.1183/09031936.00026808. Epub 2008 Sep 3.
Efthimiadis A, Spanevello A, Hamid Q, Kelly MM, Linden M, Louis R, Pizzichini MM, Pizzichini E, Ronchi C, Van Overvel F, Djukanovic R. Methods of sputum processing for cell counts, immunocytochemistry and in situ hybridisation. Eur Respir J Suppl. 2002 Sep;37:19s-23s. doi: 10.1183/09031936.02.00001902. No abstract available.
Calderazzo MA, Trujillo-Torralbo MB, Finney LJ, Singanayagam A, Bakhsoliani E, Padmanaban V, Kebadze T, Aniscenko J, Elkin SL, Johnston SL, Mallia P. Inflammation and infections in unreported chronic obstructive pulmonary disease exacerbations. Int J Chron Obstruct Pulmon Dis. 2019 Apr 10;14:823-832. doi: 10.2147/COPD.S191946. eCollection 2019.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Last Updated
August 24, 2015
Record last verified: 2011-06
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