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PHT's LogPad Collects Patient Data Used for FDA Approval
of SYMBICORT® by AstraZeneca
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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