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

NCT07419230 | Recruiting

• 1 other identifier: R-0010/25
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis

Keywords

allergen immunotherapy; Respiratory allergy; Allergic rhinitis; Adherence; Implementation; Persistance; AIT; Mobile App; Real life study; mites; grass; pollen; animal dander; sublingual; subcutaneous; SLIT; SCIT

Outcome Measures

Primary Outcomes (1)

• 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

  From entry to the end of study period at 3 years

Secondary Outcomes (4)

• Comparing the proportion of subjects who maintain therapeutic persistence after completing 2 years of Immunotherapy treatment in the active group vs control group

  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

  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

  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

  From entry to the end of study period at 3 years

Study Arms (2)

Active Group

ACTIVE COMPARATOR

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

Control Group

OTHER

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

Interventions

Active Adherence-booster App DEVICE

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

Active Group

Inactive Adherence-booster App DEVICE

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

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 who have provided the first photograph of the product for which they are entering the study

You may not qualify if:

• 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.
• Patients who have received prescription for two or more different immunotherapy products simultaneously

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead
• Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús: collaborator

Study Sites (1)

Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65

Madrid, Madrid, 28010, Spain

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Pablo Rodríguez del Río, MD PhD

CONTACT

+34915035900; prrio@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Multicenter, national study

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 18, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): March 11, 2030
• Study Completion (Estimated): March 11, 2030
• Last Updated: March 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)