There are approximately 55 million allergy sufferers in the United States, and only 5% of them are currently being treated with subcutaneous injection immunotherapy (i.e., allergy shots). Despite the myriad of prescription and OTC medications available to relieve symptoms, the only immunotherapy to prevent and reduce future allergy responses available in the United States is administered via injection.

Potential alternative

Greer Laboratories of Lenoir, NC, was founded in 1904 and provides allergy immunotherapy products and services for the treatment of humans and animals. Today, Greer is investigating the use of sublingual immunotherapy as an alternative route of administration to current injection immunotherapy.

Sublingual immunotherapy, which is not yet approved by FDA for use in the United States, treats the root cause by dispensing drops of an allergen solution under the tongue. The solution works with the body’s immune system to decrease allergic sensitivity over time. With sublingual immunotherapy no shots are required and subjects may self-administer at home instead of going to a doctor’s office. Sublingual immunotherapy has been used successfully in Europe for many years, and Greer hopes to offer allergists in the United States this alternative for treating allergies.

Paper vs electronic

Greer’s commitment to providing an effective alternative for allergy immunotherapy extends into its trial design. Greer is using cutting edge electronic patient reported outcome (ePRO) solutions from PHT Corporation of Boston instead of paper diaries in its clinical research programs.

"PHT stood out among ePRO vendors because of its excellent service," said Brad Whitlow, Greer’s clinical project manager for the trials. "The PHT team came up with innovative ideas for optimizing diary designs to ensure our primary endpoint data were captured in a way that was simple for subjects."

PHT’s LogPad System captures ePRO data on mobile handheld devices. Data are transmitted daily from subjects’ homes throughout the United States to a central server hosted by PHT. There, the data is accessed by site personnel, monitors, and sponsors in real time in order to manage subject symptoms and compliance. The LogPad System helps Greer improve data quality, enhance safety, and conduct more efficient clinical studies for this exciting investigational therapy.

Real-time results

"One of Greer’s primary concerns is for the safety of subjects enrolled in the trials," said Whitlow.

"Sites in the studies are able to monitor allergy symptoms and medication use with an online portal, PHT StudyWorks. Once data is entered by the subjects, the sites know immediately what symptoms the subjects are experiencing and are able to make the appropriate adjustments if necessary. This level of firsthand knowledge and response is only possible using a real-time ePRO solution."

One of the sites Greer is using to conduct the allergen studies is the well-known research arm of the Family Allergy and Asthma Institute in Louisville, KY. Patti Hall, RN, CCRC, director of clinical research at Family Allergy, explained:

"The major difference in using an eDiary instead of paper is a huge increase in the percentage of patient compliance, which also increases patient safety. We can track every patient and get results from their eDiaries in real time."

According to Hall, the immediate information they receive as a subject completes a questionnaire enables her team of nine coordinators and investigators to know in real time if a subject is being compliant and answering the questionnaire.

"It gives us the opportunity to keep an eye on patient safety and also to make sure they complete every question and enter data correctly," she said: "The questionnaire is designed so the patient has to answer each question appropriately before proceeding to the next one."