PHT's LogPad Collects Patient Data Used for FDA Approval of SYMBICORT® by AstraZeneca
FDA relies on primary endpoint data from two LogPad clinical trials to evaluate efficacy; data from seven LogPad trials used to prove safety
CHARLESTOWN, MA – February 14, 2007 – PHT Corporation, the market-leading provider of electronic patient-reported outcome (ePRO) solutions used in a record 275 clinical trials worldwide, is pleased to announce that primary endpoint data collected by its flagship LogPad System in two clinical trials were successfully used by the U.S. Food and Drug Administration (FDA) reviewers in the July 21, 2006, approval of SYMBICORT (budesonide/formoterol) for the long-term maintenance treatment of asthma in people 12 years of age and older. Data from seven LogPad trials were used to evaluate the safety profile of SYMBICORT. Patient data captured by PHT's ePRO systems have been successfully used in at least eight NDA submissions, with five known approvals to date, including SYMBICORT.
Industry estimates suggest 30 million people living in the United States currently suffer from asthma, with approximately 5 million asthmatics under the age of 18. SYMBICORT was approved by the FDA for the maintenance treatment of asthma in patients 12 or older.
SYMBICORT is a twice-daily asthma therapy combining budesonide, an inhaled corticosteroid, and formoterol, a rapid and long-acting beta2-agonist, into one inhaler. The United States is the first country where SYMBICORT will be available in this type of device.
This type of combination therapy is recommended by National Asthma Education and Prevention Program (NAEPP) of The National Institutes of Health (NIH) to maintain long-term control of moderate and severe persistent asthma.
The approved indication is based on data from two pivotal double blind, placebo-controlled, 12-week trials involving 1,076 patients at 45 sites in the United States. Subjects in the trials were adolescents ages 12 and over – each of whom used PHT’s LogPad to complete daytime and nighttime diaries. Patients recorded information on their Peak Expiratory Flow (PEF) scores, nighttime awakenings, sputum, coughing and breathlessness in order to provide scientific researchers with insights into treatment improvements in asthma symptoms and health-related quality of life.
The PHT LogPad System was selected for these pivotal trials to minimize errors in reliability and quality of the self-reported patient data, according to sources at AstraZeneca.
Unlike paper diaries, the LogPad offers controls on data quality – such as time response windows, reminder alarms, inherent legibility, completeness rules, programmed sequence controls, and restricted response options – while also ensuring accurate timestamps. This is especially important for asthma trials when evaluating frequently sampled PEF scores in addition to nighttime and morning symptoms, which impact the quality of life of asthma patients.
In addition to providing trustworthy data for use in submission to the FDA, the LogPad was programmed with patient alerts and site tools to improve trial management. For example, if a patient’s PEF score decreased 20% or more from baseline over three days within a rolling seven consecutive day period, the LogPad would prompt the subject to contact study personnel to discuss asthma symptoms and discontinuation. The LogPad also calculated eligibility criteria during the run-in period, helping sites more easily make randomization decisions. Patients also found the LogPad easy to use, and in total exhibited 87% compliance throughout the studies.
“The entire PHT team is proud to have played a role in the SYMBICORT trial program and recent approval,” said Phil Lee, PHT President and CEO. “At PHT, we develop technology solutions that enable trial sponsors and regulatory authorities to trust the voice of the patients involved in drug research. PHT is fully committed to continually developing and advancing ePRO solutions in order to provide the FDA and other regulatory authorities with patient self-assessment data they can trust. In this way, PHT achieves its mission of ultimately helping study sponsors treat disease and improve quality of life for individuals worldwide.”
AstraZeneca, which recently awarded seven additional SYMBICORT studies to PHT, bringing the total to 28 to date, plans to launch SYMBICORT in the U.S. in mid-2007.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
About PHT Corporation
PHT is the market-leading provider of electronic patient reported outcome (ePRO) solutions used in more than 275 clinical trials around the world. Our proven LogPad® and StudyPad® Systems deliver the voice of the patient – directly and without distortion – with reliable and timely self-reported data. By capturing more and better PRO data with reduced variance, sponsors are able to conduct smaller, faster clinical trials. Meanwhile, StudyWorks™ helps sites improve trial management efficiencies with real-time access to symptom, compliance and enrollment data. PHT’s exclusive products and features include wirelessly integrated eSense™ Sensors, real-time calculations and scoring, email safety alerts, and the mobile SimpleSend™ Wireless Pak™, which provides traditional Palm devices with global wireless data transmission capabilities. Patient data captured firsthand by PHT’s ePRO systems have been used successfully in at least eight NDA submissions to date, with five known approvals, to date. With the PHT Product Suite, biopharmaceutical and medical device companies have more control over their clinical studies and can investigate innovative new areas of scientific research – ultimately resulting in more successful trials. Learn how leading companies worldwide use and benefit from PHT’s ePRO solutions at www.phtcorp.com.
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SYMBICORT is a registered trademark of AstraZeneca. LogPad, StudyPad, PHT, StudyWorks, eSense, SimpleSend and Wireless Pak are among the trademarks and registered trademarks belonging to PHT Corporation.
© 2007 PHT Corporation
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