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.
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
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.
Parallel
Active Adherence-booster App
DeviceThe Active Adherence-booster App includes an array of short messages that will be delivered to the active arm participants to tackle previously reported factors negatively influencing adherence in AIT, such as patient´s knowledge on Allergic rhinitis and AIT as well as administration and purchase reminders. The App will also serve as electronic Case Report Form
Inactive Adherence-booster App
DeviceThe Inactive Adherence-booster App does not include any of the messages or intervention of the Active version. The App only serves as electronic Case Report Form
Comparing the proportion of subjects who maintain therapeutic persistence after completing 3 years of Immunotherapy treatment in the active and control groups
Persistence definition: time from the moment of delivery of the first product, until the estimated time of completion of the last product delivered. This definition has been previously used in this field. A difference of 15% between active and control groups will be considered as clinically meaningful, denoting success of the intervention
Comparing the proportion of subjects who maintain therapeutic persistence after completing 2 years of Immunotherapy treatment in the active group vs control group
Comparing the proportion of subjects who maintain therapeutic persistence after completing 1 years of Immunotherapy treatment in the active group vs control group
Comparing the therapeutic self-reported implementation between persistent subjects after completing 3 years of Immunotherapy in the active group vs. the control group
Self-reported implementation data will be collected using a 7 point scale, where 1 represents the best implementation possible (100% of doses correctly taken) and 7 represents treatment withdrawal (0% of doses taken). Intermediate implementation levels vary to complete the scale
Comparing AIT discontinuation reasons in non-persistent patients (ie, withdrawing the treatment), after 3 years of study will be collected
Patients withdrawing AIT will be invited to select one or more reasons for treatment discontinuation: i) AIT Adverse Events, ii) Insufficient AIT efficacy, iii) Considering AIT sufficiently efficacious as to prematurely withdrawn the treatment, iv) AIT costs, v) Lack of sufficient baseline allergy severity as to have started the treatment, vi) AIT schedule interfering patient´s lifestyle, vii) Insufficient adherence, viii) AIT discontinuated by the patient´s allergist, ix) Other reasons
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead sponsor
Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
Collaborator
