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

March 21, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2747

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • GSK Investigational Site
      • Sofia, Bulgaria, 1000
        • GSK Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • GSK Investigational Site
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • GSK Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • GSK Investigational Site
      • Kingston, Ontario, Canada, K7L 2V7
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 2P4
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • GSK Investigational Site
  • Czech Republic
      • Praha 8, Czech Republic, 182 00
        • GSK Investigational Site
  • Denmark
      • Hvidovre, Denmark, 2650
        • GSK Investigational Site
  • Netherlands
      • Horn, Netherlands, 6085 NM
        • GSK Investigational Site
  • New Zealand
      • Wellington, New Zealand, 6035
        • GSK Investigational Site
  • Norway
      • Bergen, Norway, N-5021
        • GSK Investigational Site
  • Slovenia
      • Golnik, Slovenia, 4204
        • GSK Investigational Site
  • Spain
      • Palma de Mallorca, Spain, 07014
        • GSK Investigational Site
  • Ukraine
      • Donetsk, Ukraine, 83003
        • GSK Investigational Site
      • Kiev, Ukraine, 03680
        • GSK Investigational Site
      • Kiev, Ukraine, 3680
        • GSK Investigational Site
  • United Kingdom
      • 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
        • GSK Investigational Site
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH16 4SA
        • GSK Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • GSK Investigational Site
    • California
      • Rancho Mirage, California, United States, 92270
        • GSK Investigational Site
      • Torrance, California, United States, 90502
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • GSK Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • GSK Investigational Site
      • New Haven, Connecticut, United States, 06519
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • GSK Investigational Site
      • Boston, Massachusetts, United States, 02135
        • GSK Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • GSK Investigational Site
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68131
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • GSK Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23225
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

COPD subjects and smoking and non-smoking controls

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identifying new patient subtypes and endpoints for COPD
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCO104960

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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