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NCT Number: NCT07419230

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Madrid, 28010, Spain

Location status: Recruiting

Location contact

Pablo Rodríguez del Río

CONTACT

[email protected]

+34915035900

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

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

    Time frame: From entry to the end of study period at 3 years

    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

Secondary outcomes

  1. 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

  2. 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

  3. Comparing the therapeutic self-reported implementation between persistent subjects after completing 3 years of Immunotherapy in the active group vs. the control group

    Time frame: From entry to the end of study period at 3 years

    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

  4. Comparing AIT discontinuation reasons in non-persistent patients (ie, withdrawing the treatment), after 3 years of study will be collected

    Time frame: From entry to the end of study period at 3 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Pablo Rodríguez del Río, MD PhD

CONTACT

[email protected]

+34915035900

Sponsors and collaborators

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Other

Collaborators

  • Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús

Registry information

Official study title

Pragmatic Randomized Prospective Clinical Study to Evaluate the Effectiveness of a Digital Application to Improve Aeroallergen Immunotherapy Adherence in Real Life. The NavigAITme Project

Acronym: NavigAIT

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 18, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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