Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Faculty of Medicine Porto University/Centro Hospitalar de São João
Porto, Portugal
Actively Recruiting
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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