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

RecruitingNAAges any - anyAllFundación de Investigación Biomédica - Hospital U…
NCT07419230 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 yea

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📋 Eligibility rules (as published)
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
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What it tests

  • Active Adherence-booster App
  • Inactive Adherence-booster App
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Where

1 site
Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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