Evaluation of a Digital Tool to Improve Aeroallergen Immunotherapy Adherence. NavigAITme Project

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFundación de Investigación Biomédica - Hospital Universitario de La Princesa

About this trial

Aaeroallergen Immunotherapy (AIT) is indicated in the treatment of allergic rhinitis and asthma, and has shown efficacy to control symptoms and induce immunomodulatory changes that support post discontinuation efficacy. Data from clinical trials provides founding for its efficacy and safety profile, but the therapy needs to be withheld for a minimum of 3 years, with modalities that imply daily or near daily administration of a sublingual extract, or subcutaneous injections, every 4 to 6 weeks. This treatment regimen often faces other limitations such as cost, patient´s lack of knowledge regarding efficacy/safety, or potentiality of adverse reactions. These factors have been pointed out as main reasons for a reported low level of treatment adherence in real life.

While overall literature data on treatment adherence ranges widely, from 6% to 93% of patients finalising the minimum of 3 years, current data from precise German registries inform of persistence at 3 years being very low, varying from 5.2% to 18.2% with differences depending on extract, route and patient´s age.

Surprisingly, even if the Scientific community acknowledges patient adherence as a very relevant weak point, there´s paucity of structured strategies to tackle this issue, and those available, have mostly been developed in single centers, for periods below the 3 years of AIT recommended duration. In the era of technology, and with the spreading of mobile applications (App), new approaches are currently ongoing to counteract this important drawback . In this landscape, this study aims at creating a new App that will be thoroughly tested in a prospective long-term randomized trial, to improve AIT persistence.

Eligibility criteria

Qualifiers

Patients of any age and sex

Patients who have received their first prescription for a new aeroallergen immunotherapy treatment as part of their routine care for allergic rhinitis with or without asthma

Patients who have been prescribed only a single immunotherapy product

Patients who have been prescribed a commercially available product, from any company, for sublingual or subcutaneous administration

Disqualifiers

Patients receiving AIT prescription for asthma only, and do not suffer allergic rhinitis

Administration routes other than subcutaneous or sublingual

Patients receiving AIT prescription for other indications, e.g., food or hymenoptera allergies

Patients who have received immunotherapy in the last 3 years or are currently undergoing treatment with an AIT product other than the one being studied in the current project.

Trial design

Treatments tested in this trial

  • Active Adherence-booster App
  • Inactive Adherence-booster App

Treatment groups

880 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Lead sponsor

Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús

Collaborator