PHILADELPHIA, February 08, 2012 - ERT, a global technology-driven provider of health outcomes services and customizable medical devices to biopharmaceutical sponsors and Contract Research Organizations (CROs), announces the launch of the CLEAR Study in collaboration with UCLA, an innovative program to help patients suffering from Chronic Obstructive Pulmonary Disease (COPD). COPD is a leading and increasingly prevalent disease which, according to the World Health Organization, will become the world’s third most common cause of death by 2020.
COPD is a progressive and chronic inflammatory disease of airways that typically occurs in middle-aged and older patients. There is no cure for COPD, only therapies that manage the symptoms and seek to prevent acute and debilitating events such as pulmonary exacerbations. These exacerbations are an important cause of disability and further decrease in lung function, which typically require medical therapy at the home or in the hospital. Therefore, early identification and prevention of exacerbations are important, can improve the quality of life of the patients, and can delay or decrease the demand for expensive medical care.
To identify symptoms and concerns early, ERT and UCLA will be providing enhanced services to help the patients outside the physician’s office and beyond the normal process of care. The twelve month study is specifically designed to test whether remote health monitoring:
- Is feasible in patients with moderate-severe COPD
- Improves treatment adherence, symptoms, activity level and quality of life and enables early detection of COPD exacerbations, facilitating early interventions and reducing health related expenditures
The program will operate as a randomized study for patients over 40 years old receiving their care in the Los Angeles community. The program brings together home based spirometry, activity monitoring, adherence scoring, and self-reported symptom monitoring, all enabled through technology. On a daily basis in the patient’s home, enrollees will track their lung function using ERT’s SpiroPro® which will also record symptoms through questions of the CLEAR Sx Assessment instrument. Symptoms, such as breathlessness and cough, will be tracked on the SpiroPro using a novel series of screens adapted from previously reported instruments for the detection of exacerbations. The devices will also deliver the new CLEAR Rx and CLEAR Ex Assessment instruments to determine prescription adherence and perceived activity levels. Every day, enrollees will record their physical activity levels, such as the number of steps taken per day and total activity time, using a wearable accelerometer. All patient data will be securely uploaded to a web based data tracking site where trends in symptoms and concerns with patient status can be quickly identified and addressed through clinical care.
“The breadth of services is a truly unique and innovative design for respiratory care”, notes John Sory, ERT’s Chief Development Officer. “The combined efforts of UCLA and ERT will test new approaches and could well deliver a meaningful new approach for the benefit of patients where the burden of illness is high, the need for quick intervention apparent, and the demand for new forms of care increasingly acute.”
“COPD is a serious illness and early intervention can be critical in improving COPD patients’ quality of life. We welcome the opportunity to work with ERT in helping to remotely monitor patients on a daily basis in their own homes, which may help promptly identify health problems and ensure treatment adherence. Such monitoring may prove to be an important component in the future of healthcare delivery,” said Dr. Christopher Cooper, the study’s principal investigator and professor of medicine and physiology at the David Geffen School of Medicine at UCLA.
The first of over 200 patients are expected to be recruited starting in February, 2012 and patient outcomes will be reported in late 2013. Enrollees will have full physical exams upon enrollment and at the test conclusion. Throughout the period, the metrics to be tracked will include:
• Adoption rates of remote health monitoring
• Treatment adherence in terms of percentage of days prescribed treatment is taken.
• Time to first COPD exacerbation as defined by standard criteria and number of exacerbations per year including the proportion of subjects experiencing one or more exacerbations.
• Respiratory function values such as mean daily forced expiratory volume in one second (forced spirometry), inspiratory capacity (slow spirometry), and pulse oximetry (SPO2)
• Daily activity level and symptom scores
• Utilization information such as number of physician visits, emergency department visits, hospitalizations, number of days spent in hospital, and inferred health care costs
Dr. Jeffrey Litwin, President and CEO of ERT concluded, “We are excited to work with Dr Cooper and his colleagues at UCLA to help progress the adoption of remote healthcare monitoring and we look forward to learning and sharing the results of this important trial”.
For further information on ERT and its technology and services, please email info@ERT.com, call +1 215 972 0420 or visit www.ERT.com
For further press information, please contact Laura Browne, the Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom. Phone +44 1477 539 539, Fax +44 1477 539 540, Email firstname.lastname@example.org
The David Geffen School of Medicine at UCLA is an internationally recognized leader in research, medical education and patient care. The school has more than 2,000 full-time faculty members, almost 1,300 residents, more than 750 medical students and roughly 400 Ph.D. candidates.
ERT (www.ert.com) is a global technology-driven provider of health outcomes research services and customizable medical devices supporting biopharmaceutical sponsors and Contract Research Organizations (CROs) to achieve their drug development and healthcare objectives. ERT harnesses leading technology coupled with unrivalled processes and scientific expertise to collect, analyse and report on clinical data to support the determination of health outcomes critical to the approval, labelling and reimbursement of pharmaceutical products. ERT is the acknowledged industry leader in centralized cardiac safety and respiratory efficacy services and also provides electronic Patient Reported Outcomes (ePRO) and Outcomes Assessments for multiple modalities across all phases.
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