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

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ClinicalTrials.gov Identifier: NCT00292552
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date February 14, 2006
First Posted Date February 16, 2006
Last Update Posted Date March 23, 2017
Study Start Date December 2005
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 4, 2010)
Identifying new patient subtypes and endpoints for COPD [ Time Frame: 3 years ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints
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
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 Observational
Study Design 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 Pulmonary Disease, Chronic Obstructive
Intervention Other: Novel endpoint determination
Novel endpoint determination
Study Groups/Cohorts
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 4, 2010)
2747
Original Enrollment
 (submitted: February 14, 2006)
2736
Actual Study Completion Date February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Bulgaria,   Canada,   Czech Republic,   Denmark,   Netherlands,   New Zealand,   Norway,   Slovenia,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00292552
Other Study ID Numbers SCO104960
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date March 2017