Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy (CRD-AIT)

Universidade do Porto

Status: Enrolling

Conditions: Asthma; Rhinitis, Allergic

Treatments: Diagnostic Test: Component resolved diagnosis; Diagnostic Test: Standard diagnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05448066

2017-21

Details and patient eligibility

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 2 patient groups

Standard diagnosis

Active Comparator group

Description:

Patients followed in the allergy clinic with indication for allergen immunotherapy using only standard diagnosis.

Treatment:

Diagnostic Test: Standard diagnosis

CRD diagnosis

Experimental group

Description:

Patients followed in the allergy clinic with indication for allergen immunotherapy decided with standard diagnostic tools and molecular based diagnosis.

Treatment:

Diagnostic Test: Component resolved diagnosis