First Clinical Trial with a Medical Device for Anaphylaxis Management
Sunday, March 4, 2018
South Hall A2 (Convention Center)
Victoria Cardona, MD PhD, Olga Luengo, MD, PhD, Moises Labrador-Horrillo, MD, PhD, Nuria Moreno, M.D, Ph.D, Mar Guilarte, M.D, Ph.D, Elena Pala, Adrian Curran, M.D, Ph.D, Anna Sala-Cunill, M.D, Ph.D
RATIONALE: Patients with anaphylaxis should always carry an epinephrine auto-injector (EAI), which has well-described drawbacks. The aim of this study was to evaluate the satisfaction with a medical device (anAPPhylaxisTM) to be used with EAI, which overcomes most of these drawbacks.

METHODS: Randomized, open-label, cross-over clinical trial, consecutively including anaphylaxis patients carrying an EIA. anAPPhylaxisTM is a patented smart case for EIA connected to a smartphone app with several functions that help the patient in managing anaphylaxis. The primary endpoint was satisfaction with anAPPhylaxisTM. Usability, adherence and anxiety were evaluated as secondary endpoints with specific questionnaires. Anaphylaxis episodes were registered, analyzing the potential impact of anAPPhylaxisTM during the episode.

RESULTS: 100 patients were included (mean age 39 years, 74% female) and 95 completed the trial. Satisfaction with EIA increased from 60% to 80% (p<0.05) when anAPPhylaxisTM was used. Regarding usability, 88% patients found anAPPhylaxisTM easy to use and 83% would use it frequently. Warning by the app when patients forgot the EAI was considered very useful by 95% of patients and adherence was significantly increased. Eighty-seven percent of patients were much more involved in anaphylaxis management after using the smart case. Anxiety decreased “quite” or “a lot” in 95% of patients with anAPPhylaxisTM use. Seven anaphylaxes were registered during the study and all patients felt more confident with anAPPhylaxisTM.

CONCLUSIONS: anAPPhylaxisTM increases satisfaction with EAI use, improving adherence, involvement in anaphylaxis management and decreasing anxiety in patients with anaphylaxis.