NCT05448066

Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy

Molecular Allergen Based Diagnosis Impact on Clinical Efficacy of Aeroallergen Immunotherapy- a Pragmatic Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma
• Rhinitis, Allergic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Component resolved diagnosis	Physicians in this group will have access to allergen molecular component sensitization profile, using ImmunoCAP ISAC E112i and to all standard diagnostic tolls
DIAGNOSTIC_TEST	Standard diagnosis	Physicians will only have access to standard diagnostic tools namely skin prick tests and sIgE sensitization (not molecular IgE) and clinical history.

Timeline

• Start date: 2022-07-30
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2022-07-07
• Last updated: 2025-04-06

Locations

1 site across 1 country: Portugal