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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
RECRUITING
Madrid
Contact Information
Primary
Pablo Rodríguez del Río, MD PhD
prrio@yahoo.es
+34915035900
Time Frame
Start Date: 2026-03-11
Estimated Completion Date: 2030-03-11
Participants
Target number of participants: 880
Treatments
Active_comparator: Active Group
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
Other: Control Group
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
Related Therapeutic Areas
Sponsors
Collaborators: Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
Leads: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

This content was sourced from clinicaltrials.gov

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