17/10/13 Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints - Tabular View - ClinicalTrials.

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clinicaltrials.gov/ct2/show/record/NCT00292552 1/6
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00292552
First received: February 14, 2006
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record
A service of the U.S. National Institutes of Health
Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate
Endpoints (ECLIPSE)
Tracking Information
First Received Date ICMJE
February 14, 2006
Last Updated Date January 4, 2013
Start Date ICMJE
December 2005
Primary Completion Date February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome
Measures ICMJE
(submitted: March 4, 2010)
Identifying new patient subtypes and endpoints for COPD [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Primary Outcome
Measures ICMJE
Not Provided
Change History Complete list of historical versions of study NCT00292552 on ClinicalTrials.gov Archive Site
Current Secondary
Outcome Measures ICMJE
Not Provided
Original Secondary
Outcome Measures ICMJE
Not Provided
Current Other Outcome
Measures ICMJE
Not Provided
Original Other Outcome
Measures ICMJE
Not Provided

Descriptive Information
Brief Title ICMJE
Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints
Official Title ICMJE
A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory
Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
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.
Detailed Description Not Provided
Study Type ICMJE
Observational
17/10/13 Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints - Tabular View - ClinicalTrials.gov
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Study Type ICMJE
Observational
Study Design ICMJE
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention: Samples With DNA
Description:
Whole blood, serum, plasma, urine sputum
Sampling Method Probability Sample
Study Population
COPD subjects and smoking and non-smoking controls
Condition ICMJE
Pulmonary Disease, Chronic Obstructive
Intervention ICMJE
Other: Novel endpoint determination
Novel endpoint determination
Study Group/Cohort (s)
COPD subjects
Subjects with GOLD stage II-IV COPD
Intervention: Other: Novel endpoint determination
Smoker controls
Subjects with smoking history but normal lung function
Intervention: Other: Novel endpoint determination
Non-smoker controls
Normal healthy non-smokers
Intervention: Other: Novel endpoint determination
Publications *
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.
Donaldson GC, Mllerova 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;14:79. doi: 10.1186/1465-9921-14-79.
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.
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.
Kim DK, Cho MH, Hersh CP, Lomas DA, Miller BE, Kong X, Bakke P, Gulsvik A, Agust 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.
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.
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. Epub 2012 Sep 3.
Al-shair K, Muellerova H, Yorke J, Rennard SI, Wouters EF, Hanania NA, Sharafkhaneh A, Vestbo J; ECLIPSE investigators.
Examining fatigue in COPD: development, validity and reliability of a modified version of FACIT-F scale. Health Qual Life
Outcomes. 2012 Aug 23;10:100. doi: 10.1186/1477-7525-10-100.
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,
Artigas MS, 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
17/10/13 Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints - Tabular View - ClinicalTrials.gov
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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.
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. Epub 2012 Jun 13.
Agust 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. Epub 2012 May 18.
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, Agust 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. Epub 2012 Mar 15.
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. Epub 2011 Nov 25.
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. Epub 2011 Nov 11.
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;12:146.
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. Epub 2011 Sep 26.
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, Celedn JC.
Identification of FGF7 as a novel susceptibility locus for chronic obstructive pulmonary disease. Thorax. 2011 Dec;66(12):1085-
90. Epub 2011 Sep 15.
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. Epub 2011 Jul 21.
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. Epub 2011 Jun 16.
Castaldi PJ, Cho MH, Litonjua AA, Bakke P, Gulsvik A, Lomas DA, Anderson W, Beaty TH, Hokanson JE, Crapo JD, Laird N,
Silverman EK; COPDGene and Eclipse Investigators. The association of genome-wide significant spirometric loci with chronic
obstructive pulmonary disease susceptibility. Am J Respir Cell Mol Biol. 2011 Dec;45(6):1147-53. Epub 2011 Jun 9.
Crim C, Celli B, Edwards LD, Wouters E, Coxson HO, Tal-Singer R, Calverley PM; ECLIPSE investigators. Respiratory system
impedance with impulse oscillometry in healthy and COPD subjects: ECLIPSE baseline results. Respir Med. 2011
Jul;105(7):1069-78. Epub 2011 Apr 11.
Gietema HA, Mller NL, Fauerbach PV, Sharma S, Edwards LD, Camp PG, Coxson HO; Evaluation of COPD Longitudinally to
Identify Predictive Surrogate Endpoints (ECLIPSE) investigators. Quantifying the extent of emphysema: factors associated with
radiologists' estimations and quantitative indices of emphysema severity using the ECLIPSE cohort. Acad Radiol. 2011
Jun;18(6):661-71. Epub 2011 Mar 9.
Sin DD, Miller BE, Duvoix A, Man SF, Zhang X, Silverman EK, Connett JE, Anthonisen NA, Wise RA, Tashkin D, Celli BR, Edwards
LD, Locantore N, Macnee W, Tal-Singer R, Lomas DA; ECLIPSE Investigators. Serum PARC/CCL-18 concentrations and health
outcomes in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2011 May 1;183(9):1187-92. Epub 2011 Jan 7.
Hanania NA, Mllerova H, Locantore NW, Vestbo J, Watkins ML, Wouters EF, Rennard SI, Sharafkhaneh A; Evaluation of COPD
Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study investigators. Determinants of depression in the
ECLIPSE chronic obstructive pulmonary disease cohort. Am J Respir Crit Care Med. 2011 Mar 1;183(5):604-11. Epub 2010 Oct
1.
Hurst JR, Vestbo J, Anzueto A, Locantore N, Mllerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P,
Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE)
Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-
38.
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38.
Singh D, Edwards L, Tal-Singer R, Rennard S. Sputum neutrophils as a biomarker in COPD: findings from the ECLIPSE study.
Respir Res. 2010 Jun 15;11:77.
Cho MH, Boutaoui N, Klanderman BJ, Sylvia JS, Ziniti JP, Hersh CP, DeMeo DL, Hunninghake GM, Litonjua AA, Sparrow D,
Lange C, Won S, Murphy JR, Beaty TH, Regan EA, Make BJ, Hokanson JE, Crapo JD, Kong X, Anderson WH, Tal-Singer R,
Lomas DA, Bakke P, Gulsvik A, Pillai SG, Silverman EK. Variants in FAM13A are associated with chronic obstructive pulmonary
disease. Nat Genet. 2010 Mar;42(3):200-2. Epub 2010 Feb 21.
Lomas DA, Silverman EK, Edwards LD, Locantore NW, Miller BE, Horstman DH, Tal-Singer R; Evaluation of COPD
Longitudinally to Identify Predictive Surrogate Endpoints study investigators. Serum surfactant protein D is steroid sensitive and
associated with exacerbations of COPD. Eur Respir J. 2009 Jul;34(1):95-102. Epub 2009 Jan 22.
Lomas DA, Silverman EK, Edwards LD, Miller BE, Coxson HO, Tal-Singer R; Evaluation of COPD Longitudinally to Identify
Predictive Surrogate Endpoints (ECLIPSE) investigators. Evaluation of serum CC-16 as a biomarker for COPD in the ECLIPSE
cohort. Thorax. 2008 Dec;63(12):1058-63. Epub 2008 Aug 29.
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. Epub 2008 Jan 23.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ICMJE
Completed
Enrollment ICMJE
2747
Completion Date February 2010
Primary Completion Date February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
Inclusion criteria:
COPD Subjects
A COPD subject will be eligible for inclusion in this study only if all of the following criteria apply:
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
A control subject will be eligible for inclusion in this study only if all of the following criteria apply:
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
A non-smoking control subject will be eligible for inclusion in this study only if all of the following criteria apply:
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%
Non-smokers with a smoking history of < 1 pack-year (number of pack years = (number of cigarettes per day / 20) x
number of years smoked).
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
Exclusion Criteria:
COPD Subjects
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COPD Subjects
A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
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
A control subject will not be eligible for inclusion in this study if any of the following criteria apply:
Known respiratory disorders, or disorders identified at screening/visit 1 including identification on the first CT scan (e.g.:
COPD, asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis)
Known history of significant inflammatory disease (eg 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
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
Is on long term oral corticosteroids (long term is considered use for more than 3 consecutive months)
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.
Gender Both
Ages 40 Years to 75 Years
Accepts Healthy
Volunteers
Yes
Contacts ICMJE
Contact information is only displayed when the study is recruiting subjects
Location Countries ICMJE
United States, Bulgaria, Canada, Czech Republic, Denmark, Netherlands, New Zealand, Norway, Slovenia, Spain,
Ukraine, United Kingdom

Administrative Information
NCT Number ICMJE
NCT00292552
Other Study ID Numbers
ICMJE
SCO104960
Has Data Monitoring
Committee
No
Responsible Party GlaxoSmithKline
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Study Sponsor ICMJE
GlaxoSmithKline
Collaborators ICMJE
Not Provided
Investigators ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
Information Provided By GlaxoSmithKline
Verification Date January 2013
ICMJE
Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP