Actively Recruiting

Phase Not Applicable
Age: 5Years +
All Genders
ID05448066

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

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

210

Participants Needed

1

Research Sites

8 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

Researchers are studying the use of allergen immunotherapy (AIT) for people with allergic rhinitis or asthma that do not fully respond to avoidance or medication. This research evaluates whether using a molecular-based allergy diagnosis improves the effectiveness of AIT compared to standard allergy testing. The study aims to better understand how matching allergen treatments to individual molecular sensitization patterns may impact treatment results. Participants are randomly assigned to one of two groups: one group receives immunotherapy based on standard allergy testing methods such as skin prick tests and specific IgE levels, while the other group's treatment decisions are guided by additional molecular allergen component testing using ImmunoCAP ISAC E112i. The study follows participants over a year to compare how these diagnostic approaches affect treatment outcomes. During the study, researchers will measure changes in combined symptom and medication scores, rhinitis symptoms, and control tests for allergic rhinitis and asthma at 24 and 52 weeks. Quality of life related to these conditions and patient opinions about immunotherapy will also be assessed. The study monitors participants' symptoms, medication use, and costs associated with treatment to evaluate the impact of molecular diagnosis on immunotherapy effectiveness.

CONDITIONS

Brief 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 guidelines
  • Age 5 years or older
  • Evidence of IgE-sensitization confirmed by positive skin prick tests and/or serum specific-IgE
  • Indication for immunotherapy to house dust mites and/or grass pollen; association with other allergens allowed
Not Eligible

You will not qualify if you...

  • Previous allergen immunotherapy
  • Requirement of 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week

Participants undergo allergen diagnostic tests using either standard diagnostic tools or molecular allergen component resolved diagnosis to guide immunotherapy decisions.

1 to 2 visits depending on diagnostic tests

Treatment

Duration - Up to 52 weeks

Participants receive allergen immunotherapy based on diagnostic results and clinical indication.

Regular visits as per clinical practice for immunotherapy

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

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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