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NCT05448066 | RECRUITING | Asthma

Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy
Sponsor:

University of Porto

Brief Summary:

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.

Condition or disease

Asthma

Rhinitis, Allergic

Intervention/treatment

Component resolved diagnosis

Standard diagnosis

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 210 participants
Masking : QUADRUPLE
Primary Purpose : DIAGNOSTIC
Official Title : Molecular Allergen Based Diagnosis Impact on Clinical Efficacy of Aeroallergen Immunotherapy- a Pragmatic Randomized Clinical Trial
Actual Study Start Date : 2022-07-30
Estimated Primary Completion Date : 2026-04-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 5 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Individuals with medical indication for aeroallergen immunotherapy(AIT) for allergic rhinoconjunctivitis or asthma, accordingly to the AIT guidelines;
  • * Over 5 years of age;
  • * Evidence of IgE-sensitization (positive skin prick tests and / or serum specific-IgE)
  • * Patients have indication to AIT to house dust mites and/or grass pollen, association with other allergens is not an exclusion criteria
Exclusion Criteria
  • * Previously performed allergen immunotherapy
  • * Need the use of molecular allergen diagnosis to decide treatment and diagnostic strategy
Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy

Location Details

NCT05448066

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How to Participate

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Locations

RECRUITING

Portugal,

Faculty of Medicine Porto University/São João Hospital Center

Porto, Portugal,