Digital app to improve adherence to aeroallergen immunotherapy
Official 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
Run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · NCT07419230 · Data updated 2026-11-12
This project will test whether a smartphone app can help people with allergic rhinitis keep taking their prescribed aeroallergen immunotherapy for the full treatment course.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 880 (estimated) |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | March 11, 2026 |
| Main results expected | March 11, 2030 |
| Study ends | March 11, 2030 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT07419230 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People of any age with allergic rhinitis (with or without asthma) who are starting a new, single commercial sublingual or subcutaneous aeroallergen immunotherapy and can provide a first photo of the product are ideal candidates.
✕Probably not a fit
Patients prescribed AIT for asthma only, those treated for food or hymenoptera allergies, those using routes other than sublingual/subcutaneous, or those who recently received AIT within 3 years (or who cannot use the app) are unlikely to benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants who are starting a new sublingual or subcutaneous aeroallergen immunotherapy as part of routine care will be assigned to either an active adherence‑booster app or an inactive app. The active app offers reminders, educational content, and photo-based product confirmation to encourage persistence, while the inactive app provides minimal or no adherence support. Researchers will track how well participants stick with their prescribed immunotherapy over the treatment period and compare adherence between groups. Recruitment and follow-up are conducted at participating hospitals in Madrid.
Why it matters
Potential benefit: If successful, the app could increase adherence to aeroallergen immunotherapy, leading to better symptom control and more durable benefit after treatment ends.
How similar studies have gone: Digital adherence tools have improved medication adherence in other chronic conditions, but evidence specifically showing benefit for aeroallergen immunotherapy adherence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
Madrid, Madrid, Spain Recruiting
Study contacts
- Study coordinator: Pablo Rodríguez del Río, MD PhD
- Email: prrio@yahoo.es
- Phone: +34915035900
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.