Last updated: 11/07/2018 19:01:34
Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate EndpointsECLIPSE
GSK study ID
SCO104960
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Identifying new patient subtypes and endpoints for COPD
Timeframe: 3 years
Secondary outcomes:
Not applicable
Interventions:
Other: Novel endpoint determination
Enrollment:
2747
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Castaldi PJ, Cho MH, Zhou X, Qiu W, McGeachie M, Celli B, Bakke P, Gulsvik A, Lomas DA, Crapo JD, Beaty TH, Rennard S, Harshfield B, Lange C, Singh D, Tal-Singer R, Riley JH, Quackenbush J, Raby BA, Carey VJ, Silverman EK, Hersh CP.Genetic control of gene expression at novel and established chronic obstructive pulmonary disease loci.Hum Mol Genet.2015;15(24(4)):1200-10
Glass K, Quackenbush J, Silverman EK, Celli B, Rennard SI, Yuan G-C, DeMeo DL.Sexually-dimorphic targeting of functionally-related genes in COPD.Mol Syst Biol.2014;8(1):118
Lee JH, Cho MH, Hersh CP, McDonald M-LN, Wells JM, Dransfield MT, Bowler RP, Lynch DA, Lomas DA, Crapo JD, Silverman EK, on behalf of the COPDGene and ECLIPSE Investigators.IREB2 and GALC are associated with pulmonary artery enlargement in chronic obstructive pulmonary disease.Am J Respir Cell Mol Biol.2015;52(3):365-76
Lee JH, McDonald M-LN, Cho MH, Wan ES, Castaldi PJ, Hunninghake GM, Marchetti NM, Lynch DA, Crapo JD, Lomas DA, Coxson HO, Bakke PS, Silverman EK, Hersh CP, and the COPDGene and ECLIPSE Investigators .DNAH5 is associated with total lung capacity in chronic obstructive pulmonary disease.Respir Res.2014;15(1):97
Müllerova H, Maselli DJ, Locantore N, Vestbo J, Hurst JR, Wedzicha J, Bakke P, Agusti A, Anzueto A for the ECLIPSE investigators.Hospitalized exacerbations of chronic obstructive pulmonary disease: risk factors and outcomes in the ECLIPSE cohort.Chest.2014;147(4):999-1007
Rabinovich RA, Miller BE, Wrobel K, Ranjit k, Williams MC, Crost E, Edwards LD, Lomas DA, Rennard SI, Agusti A, Tal-Singer R, Vestbo J, Wouters E, John M, Van Beek E, Murchison JT, Bolton CE, MacNee W, Huang JTJ.Circulating desmosine levels do not predict emphysema progression but are associated with cardiovascular risk and mortality in COPD.Eur Respir J.2016;47(5):1365-1373
Rennard SI, Locantore N, Delafont B, Tal-Singer R, Silverman EK, Vestbo J, Miller BE, Bakke P, Celli B, Calverley P, Coxson H, Crim C, Edwards LD, Lomas DA, MacNee W, Wouters EFM, Yates JC, Coca I, Agusti A, on behalf of the.Identification of five COPD subgroups with different prognoses in the ECLIPSE cohort using cluster analysis.Ann Am Thorac Soc.2015;12(3):303-12
Wilke S, Jones PW, Müllerova H, Vestbo J, Tal-Singer R, Franssen FME, Agusti A, Bakke P, Calverley PM, Coxson H, Crim C, Edwards L, Lomas DA, MacNee W, Rennard SI, Yates JC, Wouters EFM, Spruit M.One-year change in health status and subsequent outcomes in COPD.Thorax.2015;70(5):420-5
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2005 to February 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40 - 75 years
Accepts healthy volunteers
Yes
- COPD Subjects
- A COPD subject will be eligible for inclusion in this study only if all of the following criteria apply:
- COPD Subjects
- A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
Inclusion and exclusion criteria
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
- 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.
Trial location(s)
Location
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH16 4SA
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90502
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02135
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23225
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
New Haven, Connecticut, United States, 06519
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21224
Status
Study Complete
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06105
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02903
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Status
Study Complete
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Status
Study Complete
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2010-19-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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