Characteristics That Identify Exacerbation Risk Following Colds in COPD Patients

NCT01376830 | Completed

• 1 other identifier: CRO1697
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Exacerbations; Viruses

Outcome Measures

Primary Outcomes (1)

• Proportion of colds followed by exacerbations in COPD patients

  2 years

Secondary Outcomes (3)

• 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

Study Arms (1)

COPD patients

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients

You may qualify if:

• COPD
• Age 40-85

You may not qualify if:

• Unable to understand English
• Expected life expectancy \< 2 years
• Unable to attend hospital

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College

London, W2 1PG, United Kingdom

Location

Related Publications (21)

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  PMID: 11719299 BACKGROUND

• 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.

  PMID: 16484677 BACKGROUND

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  PMID: 19948820 BACKGROUND

• Hayden FG, Herrington DT, Coats TL, Kim K, Cooper EC, Villano SA, Liu S, Hudson S, Pevear DC, Collett M, McKinlay M; Pleconaril Respiratory Infection Study Group. Efficacy and safety of oral pleconaril for treatment of colds due to picornaviruses in adults: results of 2 double-blind, randomized, placebo-controlled trials. Clin Infect Dis. 2003 Jun 15;36(12):1523-32. doi: 10.1086/375069. Epub 2003 Jun 6.

  PMID: 12802751 BACKGROUND

• Mallia P, Message SD, Kebadze T, Parker HL, Kon OM, Johnston SL. An experimental model of rhinovirus induced chronic obstructive pulmonary disease exacerbations: a pilot study. Respir Res. 2006 Sep 6;7(1):116. doi: 10.1186/1465-9921-7-116.

  PMID: 16956406 BACKGROUND

• Mallia P, Message SD, Gielen V, Contoli M, Gray K, Kebadze T, Aniscenko J, Laza-Stanca V, Edwards MR, Slater L, Papi A, Stanciu LA, Kon OM, Johnson M, Johnston SL. Experimental rhinovirus infection as a human model of chronic obstructive pulmonary disease exacerbation. Am J Respir Crit Care Med. 2011 Mar 15;183(6):734-42. doi: 10.1164/rccm.201006-0833OC. Epub 2010 Oct 1.

  PMID: 20889904 BACKGROUND

• 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.

  PMID: 14990395 BACKGROUND

• Hurst JR, Donaldson GC, Perera WR, Wilkinson TM, Bilello JA, Hagan GW, Vessey RS, Wedzicha JA. Use of plasma biomarkers at exacerbation of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2006 Oct 15;174(8):867-74. doi: 10.1164/rccm.200604-506OC. Epub 2006 Jun 23.

  PMID: 16799074 BACKGROUND

• 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.

  PMID: 17426210 BACKGROUND

• 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.

  PMID: 18006888 BACKGROUND

• Quint JK, Donaldson GC, Goldring JJ, Baghai-Ravary R, Hurst JR, Wedzicha JA. Serum IP-10 as a biomarker of human rhinovirus infection at exacerbation of COPD. Chest. 2010 Apr;137(4):812-22. doi: 10.1378/chest.09-1541. Epub 2009 Oct 16.

  PMID: 19837822 BACKGROUND

• 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.

  PMID: 17662560 BACKGROUND

• 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.

  PMID: 19073345 BACKGROUND

• 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.

  PMID: 17218551 BACKGROUND

• Hurst JR, Donaldson GC, Wilkinson TM, Perera WR, Wedzicha JA. Epidemiological relationships between the common cold and exacerbation frequency in COPD. Eur Respir J. 2005 Nov;26(5):846-52. doi: 10.1183/09031936.05.00043405.

  PMID: 16264045 BACKGROUND

• Roberts NJ, Lloyd-Owen SJ, Rapado F, Patel IS, Wilkinson TM, Donaldson GC, Wedzicha JA. Relationship between chronic nasal and respiratory symptoms in patients with COPD. Respir Med. 2003 Aug;97(8):909-14. doi: 10.1016/s0954-6111(03)00114-8.

  PMID: 12924517 BACKGROUND

• Leidy NK, Wilcox TK, Jones PW, Roberts L, Powers JH, Sethi S; EXACT-PRO Study Group. Standardizing measurement of chronic obstructive pulmonary disease exacerbations. Reliability and validity of a patient-reported diary. Am J Respir Crit Care Med. 2011 Feb 1;183(3):323-9. doi: 10.1164/rccm.201005-0762OC. Epub 2010 Sep 2.

  PMID: 20813886 BACKGROUND

• Barrett B, Brown R, Voland R, Maberry R, Turner R. Relations among questionnaire and laboratory measures of rhinovirus infection. Eur Respir J. 2006 Aug;28(2):358-63. doi: 10.1183/09031936.06.00002606. Epub 2006 Apr 26.

  PMID: 16641127 BACKGROUND

• 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.

  PMID: 18768579 BACKGROUND

• 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.

  PMID: 12361358 BACKGROUND

• 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.

  PMID: 31114182 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum,nasal lavage, serum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Virus Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Patrick Mallia, MD, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 20, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 24, 2015

Record last verified: 2011-06

Locations

GB (1)