Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints

NCT00292552 | Completed

• 1 other identifier: SCO104960
• Study Type: observational
• Target: 2,747
• Locations: 12 countries
• Sites: 44

Brief Summary

This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease (COPD); longitudinal; eclipse

Outcome Measures

Primary Outcomes (1)

• Identifying new patient subtypes and endpoints for COPD

  3 years

Study Arms (3)

COPD subjects

Subjects with GOLD stage II-IV COPD

Other: Novel endpoint determination

Smoker controls

Subjects with smoking history but normal lung function

Other: Novel endpoint determination

Non-smoker controls

Normal healthy non-smokers

Other: Novel endpoint determination

Interventions

Novel endpoint determination OTHER

Novel endpoint determination

COPD subjects; Non-smoker controls; Smoker controls

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD subjects and smoking and non-smoking controls

You may qualify if:

• COPD Subjects
• Male or female subjects, aged 40-75 years inclusive
• A baseline (post-bronchodilator) FEV1 \<80% of predicted normal and a baseline (post-bronchodilator) FEV1/FVC ratio 70%
• Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack years = (number of cigarettes per day / 20) x number of years smoked e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
• A signed and dated written informed consent is obtained prior to participation
• Able to comply with the requirements of the protocol and be available for study visits over 3 years
• Control Subjects - Current/Ex Smokers
• Male or female subjects, aged 40-75 years inclusive, who are free from significant disease as determined by history, physical examination and screening investigations
• Baseline (post-bronchodilator) FEV1 \>85% of predicted normal. FEV1/FVC ratio \>70%
• Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack years = (number of cigarettes per day / 20) x number of years smoked e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
• A signed and dated written informed consent is obtained prior to participation.
• Able to comply with the requirements of the protocol and be available for study visits over 3 years
• Control Subjects - Non-smokers
• Male or female subjects, aged 40-75 years inclusive, who are free from significant disease as determined by history, physical examination and screening investigations
• Baseline (post-bronchodilator) FEV1 \>85% of predicted normal. FEV1/FVC ratio \>70%

You may not qualify if:

• COPD Subjects
• Known respiratory disorders, or disorders identified at screening/visit 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
• Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus)
• Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)
• Having undergone lung surgery (e.g. lung reduction, lung transplant)
• Have cancer or have had cancer in the 5 years prior to study entry
• Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety
• Is enrolled in a long term blinded drug study (subjects in open label studies may be considered and subjects in short blinded studies (approx less than 12 weeks may be considered following consultation with sponsor) or a study where there is significant radiation exposure (e.g.: CT scans)
• Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse
• Have received a blood transfusion in the 4 weeks prior to study start
• Has experienced a moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks. All courses of oral corticosteroids and antibiotics must be completed at least 2 weeks before study start
• Is on long term oral corticosteroids (long term is considered use for more than 3 consecutive months)
• Unable to walk
• Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
• Control Subjects

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (44)

GSK Investigational Site

Phoenix, Arizona, 85006, United States

Location

GSK Investigational Site

Rancho Mirage, California, 92270, United States

Location

GSK Investigational Site

Torrance, California, 90502, United States

Location

GSK Investigational Site

Denver, Colorado, 80206, United States

Location

GSK Investigational Site

Hartford, Connecticut, 06105, United States

Location

GSK Investigational Site

New Haven, Connecticut, 06519, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21224, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02115, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02135, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Location

GSK Investigational Site

Saint Charles, Missouri, 63301, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68131, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68198, United States

Location

GSK Investigational Site

Lebanon, New Hampshire, 03756, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

GSK Investigational Site

Providence, Rhode Island, 02903, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Richmond, Virginia, 23225, United States

Location

GSK Investigational Site

Pleven, 5800, Bulgaria

Location

GSK Investigational Site

Sofia, 1000, Bulgaria

Location

GSK Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

GSK Investigational Site

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

GSK Investigational Site

Kingston, Ontario, K7L 2V7, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2X 2P4, Canada

Location

GSK Investigational Site

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

GSK Investigational Site

Prague, 182 00, Czechia

Location

GSK Investigational Site

Hvidovre, 2650, Denmark

Location

GSK Investigational Site

Horn, 6085 NM, Netherlands

Location

GSK Investigational Site

Wellington, 6035, New Zealand

Location

GSK Investigational Site

Bergen, N-5021, Norway

Location

GSK Investigational Site

Golnik, 4204, Slovenia

Location

GSK Investigational Site

Palma de Mallorca, 07014, Spain

Location

GSK Investigational Site

Donetsk, 83003, Ukraine

Location

GSK Investigational Site

Kiev, 03680, Ukraine

Location

GSK Investigational Site

Kiev, 3680, Ukraine

Location

GSK Investigational Site

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

GSK Investigational Site

Cambridge, CB2 2XY, United Kingdom

Location

GSK Investigational Site

Liverpool, L9 7AL, United Kingdom

Location

GSK Investigational Site

London, NW3 2QG, United Kingdom

Location

GSK Investigational Site

Manchester, M23 9LT, United Kingdom

Location

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• Menche J, Sharma A, Cho MH, Mayer RJ, Rennard SI, Celli B, Miller BE, Locantore N, Tal-Singer R, Ghosh S, Larminie C, Bradley G, Riley JH, Agusti A, Silverman EK, Barabasi AL. A diVIsive Shuffling Approach (VIStA) for gene expression analysis to identify subtypes in Chronic Obstructive Pulmonary Disease. BMC Syst Biol. 2014;8 Suppl 2(Suppl 2):S8. doi: 10.1186/1752-0509-8-S2-S8. Epub 2014 Mar 13.

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• Wells JM, O'Reilly PJ, Szul T, Sullivan DI, Handley G, Garrett C, McNicholas CM, Roda MA, Miller BE, Tal-Singer R, Gaggar A, Rennard SI, Jackson PL, Blalock JE. An aberrant leukotriene A4 hydrolase-proline-glycine-proline pathway in the pathogenesis of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 Jul 1;190(1):51-61. doi: 10.1164/rccm.201401-0145OC.

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• Vestbo J, Agusti A, Wouters EF, Bakke P, Calverley PM, Celli B, Coxson H, Crim C, Edwards LD, Locantore N, Lomas DA, MacNee W, Miller B, Rennard SI, Silverman EK, Yates JC, Tal-Singer R; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints Study Investigators. Should we view chronic obstructive pulmonary disease differently after ECLIPSE? A clinical perspective from the study team. Am J Respir Crit Care Med. 2014 May 1;189(9):1022-30. doi: 10.1164/rccm.201311-2006PP.

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• Coxson HO, Dirksen A, Edwards LD, Yates JC, Agusti A, Bakke P, Calverley PM, Celli B, Crim C, Duvoix A, Fauerbach PN, Lomas DA, Macnee W, Mayer RJ, Miller BE, Muller NL, Rennard SI, Silverman EK, Tal-Singer R, Wouters EF, Vestbo J; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. The presence and progression of emphysema in COPD as determined by CT scanning and biomarker expression: a prospective analysis from the ECLIPSE study. Lancet Respir Med. 2013 Apr;1(2):129-36. doi: 10.1016/S2213-2600(13)70006-7. Epub 2013 Feb 1.

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• Cheng DT, Kim DK, Cockayne DA, Belousov A, Bitter H, Cho MH, Duvoix A, Edwards LD, Lomas DA, Miller BE, Reynaert N, Tal-Singer R, Wouters EF, Agusti A, Fabbri LM, Rames A, Visvanathan S, Rennard SI, Jones P, Parmar H, MacNee W, Wolff G, Silverman EK, Mayer RJ, Pillai SG; TESRA and ECLIPSE Investigators. Systemic soluble receptor for advanced glycation endproducts is a biomarker of emphysema and associated with AGER genetic variants in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Oct 15;188(8):948-57. doi: 10.1164/rccm.201302-0247OC.

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• Ubhi BK, Davenport PW, Welch M, Riley J, Griffin JL, Connor SC. Analysis of chloroformate-derivatised amino acids, dipeptides and polyamines by LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2013 Sep 1;934:79-88. doi: 10.1016/j.jchromb.2013.06.026. Epub 2013 Jun 29.

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• Donaldson GC, Mullerova H, Locantore N, Hurst JR, Calverley PM, Vestbo J, Anzueto A, Wedzicha JA. Factors associated with change in exacerbation frequency in COPD. Respir Res. 2013 Jul 30;14(1):79. doi: 10.1186/1465-9921-14-79.

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• Berg I, Hanson C, Sayles H, Romberger D, Nelson A, Meza J, Miller B, Wouters EF, Macnee W, Rutten EP, Romme EA, Vestbo J, Edwards L, Rennard S. Vitamin D, vitamin D binding protein, lung function and structure in COPD. Respir Med. 2013 Oct;107(10):1578-88. doi: 10.1016/j.rmed.2013.05.010. Epub 2013 Jul 1.

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• Sumner H, Woodcock A, Kolsum U, Dockry R, Lazaar AL, Singh D, Vestbo J, Smith JA. Predictors of objective cough frequency in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 May 1;187(9):943-9. doi: 10.1164/rccm.201211-2000OC.

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• Zhou X, Qiu W, Sathirapongsasuti JF, Cho MH, Mancini JD, Lao T, Thibault DM, Litonjua AA, Bakke PS, Gulsvik A, Lomas DA, Beaty TH, Hersh CP, Anderson C, Geigenmuller U, Raby BA, Rennard SI, Perrella MA, Choi AM, Quackenbush J, Silverman EK. Gene expression analysis uncovers novel hedgehog interacting protein (HHIP) effects in human bronchial epithelial cells. Genomics. 2013 May;101(5):263-72. doi: 10.1016/j.ygeno.2013.02.010. Epub 2013 Mar 1.

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• Kim DK, Cho MH, Hersh CP, Lomas DA, Miller BE, Kong X, Bakke P, Gulsvik A, Agusti A, Wouters E, Celli B, Coxson H, Vestbo J, MacNee W, Yates JC, Rennard S, Litonjua A, Qiu W, Beaty TH, Crapo JD, Riley JH, Tal-Singer R, Silverman EK; ECLIPSE, ICGN, and COPDGene Investigators. Genome-wide association analysis of blood biomarkers in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1238-47. doi: 10.1164/rccm.201206-1013OC. Epub 2012 Nov 9.

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• Ubhi BK, Cheng KK, Dong J, Janowitz T, Jodrell D, Tal-Singer R, MacNee W, Lomas DA, Riley JH, Griffin JL, Connor SC. Targeted metabolomics identifies perturbations in amino acid metabolism that sub-classify patients with COPD. Mol Biosyst. 2012 Oct 30;8(12):3125-33. doi: 10.1039/c2mb25194a.

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• Wells JM, Washko GR, Han MK, Abbas N, Nath H, Mamary AJ, Regan E, Bailey WC, Martinez FJ, Westfall E, Beaty TH, Curran-Everett D, Curtis JL, Hokanson JE, Lynch DA, Make BJ, Crapo JD, Silverman EK, Bowler RP, Dransfield MT; COPDGene Investigators; ECLIPSE Study Investigators. Pulmonary arterial enlargement and acute exacerbations of COPD. N Engl J Med. 2012 Sep 6;367(10):913-21. doi: 10.1056/NEJMoa1203830. Epub 2012 Sep 3.

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• Wilk JB, Shrine NR, Loehr LR, Zhao JH, Manichaikul A, Lopez LM, Smith AV, Heckbert SR, Smolonska J, Tang W, Loth DW, Curjuric I, Hui J, Cho MH, Latourelle JC, Henry AP, Aldrich M, Bakke P, Beaty TH, Bentley AR, Borecki IB, Brusselle GG, Burkart KM, Chen TH, Couper D, Crapo JD, Davies G, Dupuis J, Franceschini N, Gulsvik A, Hancock DB, Harris TB, Hofman A, Imboden M, James AL, Khaw KT, Lahousse L, Launer LJ, Litonjua A, Liu Y, Lohman KK, Lomas DA, Lumley T, Marciante KD, McArdle WL, Meibohm B, Morrison AC, Musk AW, Myers RH, North KE, Postma DS, Psaty BM, Rich SS, Rivadeneira F, Rochat T, Rotter JI, Soler Artigas M, Starr JM, Uitterlinden AG, Wareham NJ, Wijmenga C, Zanen P, Province MA, Silverman EK, Deary IJ, Palmer LJ, Cassano PA, Gudnason V, Barr RG, Loos RJ, Strachan DP, London SJ, Boezen HM, Probst-Hensch N, Gharib SA, Hall IP, O'Connor GT, Tobin MD, Stricker BH. Genome-wide association studies identify CHRNA5/3 and HTR4 in the development of airflow obstruction. Am J Respir Crit Care Med. 2012 Oct 1;186(7):622-32. doi: 10.1164/rccm.201202-0366OC. Epub 2012 Jul 26.

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• Albert P, Agusti A, Edwards L, Tal-Singer R, Yates J, Bakke P, Celli BR, Coxson HO, Crim C, Lomas DA, Macnee W, Miller B, Rennard S, Silverman EK, Vestbo J, Wouters E, Calverley P. Bronchodilator responsiveness as a phenotypic characteristic of established chronic obstructive pulmonary disease. Thorax. 2012 Aug;67(8):701-8. doi: 10.1136/thoraxjnl-2011-201458. Epub 2012 Jun 13.

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• Agusti A, Edwards LD, Rennard SI, MacNee W, Tal-Singer R, Miller BE, Vestbo J, Lomas DA, Calverley PM, Wouters E, Crim C, Yates JC, Silverman EK, Coxson HO, Bakke P, Mayer RJ, Celli B; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Persistent systemic inflammation is associated with poor clinical outcomes in COPD: a novel phenotype. PLoS One. 2012;7(5):e37483. doi: 10.1371/journal.pone.0037483. Epub 2012 May 18.

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• Celli BR, Locantore N, Yates J, Tal-Singer R, Miller BE, Bakke P, Calverley P, Coxson H, Crim C, Edwards LD, Lomas DA, Duvoix A, MacNee W, Rennard S, Silverman E, Vestbo J, Wouters E, Agusti A; ECLIPSE Investigators. Inflammatory biomarkers improve clinical prediction of mortality in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 May 15;185(10):1065-72. doi: 10.1164/rccm.201110-1792OC. Epub 2012 Mar 15.

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• Waschki B, Spruit MA, Watz H, Albert PS, Shrikrishna D, Groenen M, Smith C, Man WD, Tal-Singer R, Edwards LD, Calverley PM, Magnussen H, Polkey MI, Wouters EF. Physical activity monitoring in COPD: compliance and associations with clinical characteristics in a multicenter study. Respir Med. 2012 Apr;106(4):522-30. doi: 10.1016/j.rmed.2011.10.022. Epub 2011 Nov 25.

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• Cho MH, Castaldi PJ, Wan ES, Siedlinski M, Hersh CP, Demeo DL, Himes BE, Sylvia JS, Klanderman BJ, Ziniti JP, Lange C, Litonjua AA, Sparrow D, Regan EA, Make BJ, Hokanson JE, Murray T, Hetmanski JB, Pillai SG, Kong X, Anderson WH, Tal-Singer R, Lomas DA, Coxson HO, Edwards LD, MacNee W, Vestbo J, Yates JC, Agusti A, Calverley PM, Celli B, Crim C, Rennard S, Wouters E, Bakke P, Gulsvik A, Crapo JD, Beaty TH, Silverman EK; ICGN Investigators; ECLIPSE Investigators; COPDGene Investigators. A genome-wide association study of COPD identifies a susceptibility locus on chromosome 19q13. Hum Mol Genet. 2012 Feb 15;21(4):947-57. doi: 10.1093/hmg/ddr524. Epub 2011 Nov 11.

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• Dickens JA, Miller BE, Edwards LD, Silverman EK, Lomas DA, Tal-Singer R; Evaluation of COPD Longitudinally to Identify Surrogate Endpoints (ECLIPSE) study investigators. COPD association and repeatability of blood biomarkers in the ECLIPSE cohort. Respir Res. 2011 Nov 4;12(1):146. doi: 10.1186/1465-9921-12-146.

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• Vestbo J, Edwards LD, Scanlon PD, Yates JC, Agusti A, Bakke P, Calverley PM, Celli B, Coxson HO, Crim C, Lomas DA, MacNee W, Miller BE, Silverman EK, Tal-Singer R, Wouters E, Rennard SI; ECLIPSE Investigators. Changes in forced expiratory volume in 1 second over time in COPD. N Engl J Med. 2011 Sep 29;365(13):1184-92. doi: 10.1056/NEJMoa1105482. Epub 2011 Sep 26.

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• Brehm JM, Hagiwara K, Tesfaigzi Y, Bruse S, Mariani TJ, Bhattacharya S, Boutaoui N, Ziniti JP, Soto-Quiros ME, Avila L, Cho MH, Himes B, Litonjua AA, Jacobson F, Bakke P, Gulsvik A, Anderson WH, Lomas DA, Forno E, Datta S, Silverman EK, Celedon JC. Identification of FGF7 as a novel susceptibility locus for chronic obstructive pulmonary disease. Thorax. 2011 Dec;66(12):1085-90. doi: 10.1136/thoraxjnl-2011-200017. Epub 2011 Sep 15.

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• Spruit MA, Polkey MI, Celli B, Edwards LD, Watkins ML, Pinto-Plata V, Vestbo J, Calverley PM, Tal-Singer R, Agusti A, Coxson HO, Lomas DA, MacNee W, Rennard S, Silverman EK, Crim CC, Yates J, Wouters EF; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study investigators. Predicting outcomes from 6-minute walk distance in chronic obstructive pulmonary disease. J Am Med Dir Assoc. 2012 Mar;13(3):291-7. doi: 10.1016/j.jamda.2011.06.009. Epub 2011 Jul 21.

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• Siedlinski M, Cho MH, Bakke P, Gulsvik A, Lomas DA, Anderson W, Kong X, Rennard SI, Beaty TH, Hokanson JE, Crapo JD, Silverman EK; COPDGene Investigators; ECLIPSE Investigators. Genome-wide association study of smoking behaviours in patients with COPD. Thorax. 2011 Oct;66(10):894-902. doi: 10.1136/thoraxjnl-2011-200154. Epub 2011 Jun 16.

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Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma, urine sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 16, 2006
• Study Start: December 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 23, 2017

Record last verified: 2017-03

Locations

DK (1); NZ (1); NO (1); US (20); CA (7); ES (1); UA (3); GB (5); CZ (1); SL (1); BU (2); NL (1)