A Breath of Fresh Air
How ePRO improves Asthma and Rhinoconjunctivitis clinical studies
The Time is Now
Sponsors elect to use ePRO to capture data from asthma patients primarily because of the
importance of collecting timely and frequent assessments. The LogPad’s accurate time-
stamps ensure data are entered at appropriate times according to the protocl, while its
intuitive touchscreen interface, reminder alarms and branching logic reduce respondent
burden especially during periods of dense sampling. eSense device integration further
elevates the reliability of patient data to unprecedented heights.
Whether you are implementing a diary question about the degree of breathing difficulty,
or comparing PEF and FEV1scores to baseline, PHT’s LogPad System enables higher quality
data and safer clinical research worldwide.
Behind only disorders of the Central Nervous System, the majority of PHT’s market-leading
clinical trial experience is in the Respiratory therapeutic area, a significant percentage of
which are allergy and rhinoconjunctivitis studies*:
Clinical Trials 35
Subjects 14,000 (includes pediatrics) eSense Device Integration
Wirelessly integrated PEF meters,
Sites 2,100 pioneered by PHT, have become the
By Phase Phase II (30%) - Phase III (58%) - Phase IV (12%) gold standard in asthma research.
Subjects use the PEF meter throughout
Questionnaires Asthma Control Quesitonnaire (ACQ-5), Asthma Quality of the day, and all timestamped scores
Life Questionnaire (AQLQ), Rhinioconjunctivitis Quality of Life are sent automatically to the LogPad.
Questionnaire (RQLQ), St. George’s Respiratory Questionnaire This eliminates invented data, user
(SGRQ),Total Nasal Symptom Score (TNSS) error, and transcription error typical of
Countries Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, asthma and pediatric asthma trials.
Costa Rica, Colombia, Czech Republic, Denmark, France,
Germany, Hungary, Israel, Indonesia, Italy, Latvia, Mexico, PHT Client Case Study
Netherlands, New Zealand, Pakistan, Peru, Phillipines, Poland, One sponsor allowed subjects to use
Portugal, Puerto Rico, Russia, Singapore, Slovakia, South Africa, eSense integration or enter readings
South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, manually into the eDiary.
United Kingdom, United States
As presented in a poster at the 2008
Languages Afrikaans, Bulgarian, Chinese (China, Singapore, Taiwan), Czech,
AAAAI Annual Meeting, 86.5% of
Danish, Dutch, English (Australia, UK, US), Flemish, French
12,195 expected blows were sent to the
(Belgium, Canada, France), German, Hangul, Hebrew, Hindi,
LogPad via eSense, 12.5% were entered
Hungarian, Indonesian, Italian, Latvian, Malay, Polish, Portu-
manually, and only 1.0% were missed.
guese (Brazil, Portugal), Spanish (Argentina, Costa Rica, Puerto
Rico, Russian, Peru, Spain, US), Swedish, Tagalog, Thai, Urdu
These results demonstrate frequent
voluntary use of the eSense PiKo
* As of September, 2008
provides a significant increase in data
reliability over antiquated paper diaries
or disconnected eSource methods.
NDA Approval of SYBMICORT® by AstraZeneca
The FDA approved the use of SYBMICORT (budesonide/formoterol) in the United States based on primary efficacy
data captured in two LogPad trials with 1,076 patients. Data from seven LogPad studies were used to prove safety.