An interventional study of Active Adherence-booster App and Inactive Adherence-booster App in Allergic Rhinitis, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Not applicable, Interventional, and Other
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.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 880 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Fundación de Investigación Biomédica - Hospital Universitario de La Princesa is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
This is the arm of the study where patients will receive the intervention, ie: adherence-booster App. All participants in this arm will download the mobile App. This App will have two main objectives: i) deliver the intervention, mainly messages to improve patient´s education on allergic conditions and Aeroallergen Immunotherapy as well as administration and purchase reminders. ii) serve as electronic Case Report Form allowing patients providing feedback to inform study variables
Device: Active Adherence-booster App
This is the arm of the study where patients will NOT receive the intervention, ie: adherence-booster App. All participants in this arm will download the mobile App. This App will have only one objective: i) serve as electronic Case Report Form allowing patients providing feedback to inform study variables
Device: Inactive Adherence-booster App
The 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
The 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
Time frame: From entry to the end of study period at 3 years
Comparing the proportion of subjects who maintain therapeutic persistence after completing 2 years of Immunotherapy treatment in the active group vs control group
Time frame: From entry to the end of second year of study period
Comparing the proportion of subjects who maintain therapeutic persistence after completing 1 years of Immunotherapy treatment in the active group vs control group
Time frame: From entry to the end of first year of study period
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
Time frame: From entry to the end of study period at 3 years
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
Time frame: From entry to the end of study period at 3 years
Plan to share: No
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Started Mar 2026 (actual). Primary completion is estimated for Mar 2030, 48 months after the start.
Of 66 non-industry interventional studies with no phase under Rhinitis, Allergic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's planned 48 months is above that.
Counting every sponsor, half of 87 studies reached it within 11 months; a quarter within 4 and three quarters within 27.
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa