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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00292552
First received: February 14, 2006
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Other: Novel endpoint determination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Identifying new patient subtypes and endpoints for COPD [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma, urine sputum


Enrollment: 2747
Study Start Date: December 2005
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
COPD subjects
Subjects with GOLD stage II-IV COPD
Other: Novel endpoint determination
Novel endpoint determination
Smoker controls
Subjects with smoking history but normal lung function
Other: Novel endpoint determination
Novel endpoint determination
Non-smoker controls
Normal healthy non-smokers
Other: Novel endpoint determination
Novel endpoint determination

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

COPD subjects and smoking and non-smoking controls

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292552

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
United States, California
GSK Investigational Site
Rancho Mirage, California, United States, 92270
GSK Investigational Site
Torrance, California, United States, 90502
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80206
United States, Connecticut
GSK Investigational Site
Hartford, Connecticut, United States, 06105
GSK Investigational Site
New Haven, Connecticut, United States, 06519
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33136
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21224
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02115
GSK Investigational Site
Boston, Massachusetts, United States, 02135
United States, Minnesota
GSK Investigational Site
Rochester, Minnesota, United States, 55905
United States, Missouri
GSK Investigational Site
St. Charles, Missouri, United States, 63301
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68131
GSK Investigational Site
Omaha, Nebraska, United States, 68198
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02903
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23225
Bulgaria
GSK Investigational Site
Pleven, Bulgaria, 5800
GSK Investigational Site
Sofia, Bulgaria, 1000
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
GSK Investigational Site
Kingston, Ontario, Canada, K7L 2V7
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2X 2P4
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G5
Czech Republic
GSK Investigational Site
Praha 8, Czech Republic, 182 00
Denmark
GSK Investigational Site
Hvidovre, Denmark, 2650
Netherlands
GSK Investigational Site
Horn, Netherlands, 6085 NM
New Zealand
GSK Investigational Site
Wellington, New Zealand, 6035
Norway
GSK Investigational Site
Bergen, Norway, N-5021
Slovenia
GSK Investigational Site
Golnik, Slovenia, 4204
Spain
GSK Investigational Site
Palma de Mallorca, Spain, 07014
Ukraine
GSK Investigational Site
Kiev, Ukraine, 03680
United Kingdom
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH16 4SA
GSK Investigational Site
Cambridge, United Kingdom, CB2 2XY
GSK Investigational Site
Liverpool, United Kingdom, L9 7AL
GSK Investigational Site
London, United Kingdom, NW3 2QG
GSK Investigational Site
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 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.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00292552     History of Changes
Other Study ID Numbers: SCO104960
Study First Received: February 14, 2006
Last Updated: January 4, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Chronic Obstructive Pulmonary Disease (COPD)
longitudinal
eclipse

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014