Actively Recruiting

Phase Not Applicable
Age: 5Years +
All Genders
NCT05448066

Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy

Led by Universidade do Porto · Updated on 2025-04-06

210

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

U

Universidade do Porto

Lead Sponsor

S

Sociedade Portuguesa de Alergologia e Imunologia Clinica

Collaborating Sponsor

AI-Summary

What this Trial Is About

Allergen immunotherapy (AIT) is used for the control of allergic diseases that are not completely responsive to avoidance strategies and/or pharmacotherapy. It is also considered the main treatment with the potential to modify allergic disease evolution. It's efficacy and safety in allergic rhinitis and asthma is supported by large systematic reviews and is recommended as a cornerstone treatment option in allergic disease. Molecular based allergy diagnosis has greatly evolved and the knowledge of molecular allergen sensitization pattern has been used to better define the allergen extract composition of AIT. However, uncertainty remains if this strategy is related to an increase of efficacy. Regulation of allergen extracts for allergen immunotherapy are currently underway in Europe, but there is still lack of standardization of relevant allergens and important differences are seen between allergenic contents. Therefore, we aim to evaluate, in a real-life setting, the impact of using molecular-based diagnosis versus standard diagnostic tools in the efficacy of aeroallergen immunotherapy, using a pragmatic randomized controlled trial design and also to address the impact of the discrepancy between individual aeroallergen sensitization profiles and the major allergen molecular content of aeroallergen immunotherapy.

CONDITIONS

Official Title

Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy

Who Can Participate

Age: 5Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with medical indication for aeroallergen immunotherapy for allergic rhinoconjunctivitis or asthma according to AIT guidelines
  • Over 5 years of age
  • Evidence of IgE-sensitization (positive skin prick tests and/or serum specific-IgE)
  • Indication to AIT for house dust mites and/or grass pollen; association with other allergens allowed
Not Eligible

You will not qualify if you...

  • Previously received allergen immunotherapy
  • Need for molecular allergen diagnosis to decide treatment and diagnostic strategy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Faculty of Medicine Porto University/Centro Hospitalar de São João

Porto, Portugal

Actively Recruiting

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Research Team

D

Diana M Silva, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy | DecenTrialz