NCT05448066 Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy
| NCT ID | NCT05448066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidade do Porto |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2022-07-30 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2022-07-30 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Diana Silva
PRINCIPAL INVESTIGATOR
Faculty of Medicine Porto University
Frequently Asked Questions
Who can join the NCT05448066 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05448066 currently recruiting?
Yes, NCT05448066 is actively recruiting participants. Contact the research team at dianapereirasilva@chsj.min-saude.pt for enrollment information.
Where is the NCT05448066 trial being conducted?
This trial is being conducted at Porto, Portugal.
Who is sponsoring the NCT05448066 clinical trial?
NCT05448066 is sponsored by Universidade do Porto. The principal investigator is Diana Silva at Faculty of Medicine Porto University. The trial plans to enroll 210 participants.
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