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GSK to make ECLIPSE data available to investigators through new research collaboration

Collaboration encompasses systems biology research and data coordination

GSK and the Channing Division of Network Medicine at the Brigham and Women’s Hospital (BWH) (http://brighamandwomens.org/research/depts/
medicine/channing/researchprojects.aspx
) have signed a collaborative research agreement for ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints). Under the agreement, BWH has assumed data coordinating centre functions for ECLIPSE, including the integration of the existing data sets (clinical, physiological, imaging, genetics, and –omics) with recently obtained eight year survival data and data from the ECLIPSE investigator-led extension study in Europe. The data coordinating center will provide data sets to investigators with approved ancillary studies in ECLIPSE. There is an intention to submit the integrated ECLIPSE data set to the database of Genotypes and Phenotypes dbGaP (www.ncbi.nlm.nih.gov/gap), if feasible. In addition, BWH Channing Division will also perform systems biology research and conduct biostatistical data analysis using the ECLIPSE data.

Click on the links below to read comments from

Ruth Tal-Singer, Vice President for clinical discovery at GSK
Edwin K. Silverman, Chief of the Channing Division of Network Medicine at BWH

Requests for data from the ECLIPSE database should be directed to: eclipseDCC@channing.harvard.edu at the Channing Division of Network Medicine.

What is ECLIPSE?

The ECLIPSE study is a non-interventional, observational, multicentre, three-year study in people with Chronic Obstructive Pulmonary Disease (COPD). COPD is most commonly caused by smoking and is usually diagnosed based on a history of exposure to risk factors and the presence of airflow limitation that is not fully reversible (as measured by spirometry). However, spirometry only measures one aspect of disease – airway obstruction. Therefore in order to expand disease understanding and enable the development of more treatment options to optimise management of all aspects of the disease (e.g. muscle dysfunction, mucus hypersecretion, emphysema, dyspnea and cough), better characterisation of the disease entities that make up COPD is required. In addition, identification of more sensitive measures and/or markers of disease progression are also needed.

The ECLIPSE study was therefore designed to determine the underlying mechanisms of disease progression and identify biomarkers that may serve as surrogate endpoints and therefore measures of disease progression. ECLIPSE is a unique collaborative project between external experts and industry.

  • ECLIPSE is the first study to investigate novel endpoints in COPD disease progression.
  • ECLIPSE will provide a greater insight into patient needs and expand COPD disease understanding – causes, processes, patterns and progression.
  • The ECLIPSE study is leading the advancement of scientific and medical investigation into COPD.

Click on the links below to learn more about

Study design
Study endpoints

Last updated: March 2016

“ECLIPSE is a large and well-characterized study population, which has already proven to be extremely useful for studies of COPD epidemiology and genetics. We are pleased to assist the general scientific community in advancing research in COPD through this valuable data set.”

Edwin K. Silverman, Chief of the Channing Division of Network Medicine at BWH

“To maximize the value of ECLIPSE we have been sharing data with individual researchers and Consortia including COPDGene, the COPD Biomarker Consortium and U-BIOPRED based on written proposals approved by the Steering and Scientific Committees. Collaboration led to important insights and publications in COPD including the qualification of the biomarker plasma fibrinogen as a drug development tool by the FDA. To improve access to the wider academic community, we are now making the data available through the Channing data coordinating centre. We hope this will make it easier for interested clinical researchers to access the data from this unique collaborative longitudinal study in COPD.”

Ruth Tal-Singer, Vice President for COPD clinical discovery at GSK

Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease state characterised by airflow limitation that is not fully reversible. COPD is an umbrella term, which is used to describe chronic bronchitis, emphysema or a combination of these. COPD is most commonly caused by smoking and is usually diagnosed based on a history of exposure to risk factors and the presence of airflow limitation that is not fully reversible (as measured by spirometry). It is a fatal lung disease that kills more people each year than lung cancer and breast cancer combined. As there is no cure for COPD, all currently available treatments concentrate on slowing progression of the disease, controlling symptoms and reducing complications.

Spirometry (a relatively simple lung function test) measures forced expiratory volume in one second (FEV1) which is used for the diagnosis and staging of COPD. However there is wide acceptance that it is a crude measure and insensitive to change over shorter periods of time and only measures one clinical manifestation of COPD: airway obstruction. Therefore in order to expand disease understanding and enable the development of more treatment options to optimise management of all aspects of the disease (e.g. muscle dysfunction, mucus hypersecretion, emphysema, dyspnoea and cough), better characterisation of the disease entities that make up COPD is required. In addition, identification of more sensitive measures and/or markers of disease progression are also needed.

Design: ECLIPSE is a non-interventional, longitudinal prospective three-year study in people with COPD and control subjects. In the study, novel COPD biochemical, radiological and physiological biomarker endpoints will be compared with FEV1 in COPD patients and control subjects.

design

Study procedures performed at 8 visits (baseline, 3 months, 6 months, and then every 6 months for 3 years).

Endpoints

Assessments include:

  • Pulmonary function measurements (plethysmography, spirometry and forced oscillometry)
  • Biomarkers (in blood, sputum, urine, and exhaled breath condensate for proteomic and metabolomic analysis)
  • Health outcomes
  • Chest computed tomography scans
  • Body impedance
  • Resting oxygen saturation
  • 6 minute walk distance

Note: list above is not in any order of importance.

 

GlaxoSmithkline is proud to collaborate with leading external experts in this unique, groundbreaking 3-year study.