Astra-Zeneca’s Symbicort, an inhaled combination therapy for asthma, was approved by the FDA with the use of data from an electronic patient-reported outcome (ePRO) handheld device from PHT.

It’s a major win for the Boston e-diary company. The approval also appears to be an additional sign that the FDA feels the electronic patient diary data is solid. The agency has hardly made it a secret that it would like to wean the industry away from the ludicrous anachronism of handwritten paper diaries for patients in clinical trials, which have been proven to contain pervasively back- and forward-dated entries.

We’re working on getting a few more details about the COMIC trial of Symbicort, which combines budesonide and formoterol. In the meantime, here’s some of what PHT says in its release:

“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.”

In the release, PHT says that 275 trials and four previous FDA approvals (and seven FDA submissions) have relied upon its Palm-based patient-diary platform.

Said Phil Lee, PHT’s president and CEO: “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.”